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ProtocolTrial Name and Objective
021202

A Randomized Trial Testing a Probiotic Enteric Regimen for Easing Complications of Transplant (Randomized PERFECT Trial)

Primary: To determine if allogeneic hematopoietic stem cell transplant patients treated with a probiotic containing diet compared to those not assigned to receive probiotic have a lower incidence of grade 1 upper GI or grade 2-4 lower GI acute GVHD using CIBMTR scoring than those not prescribed a probiotic.
Secondary: To determine if allogeneic hematopoietic stem cell transplant patients treated with a probiotic-containing diet compared to those not assigned to receive a probiotic have (a) lower rate of organ-specific GVHD; (b) lower rate of moderate to severe chronic GVHD at 6 months and 1 year post transplant; (c) shorter duration of immunosuppressive therapy; (d) lower rate of bacterial and/or opportunistic infection.
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011202

Autologous stem cell transplant with Pomalidomide (CC-4047) Maintenance versus continuous Clarithromycin/Pomalidomide/Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma: A Phase 2 open-Label Randomized study by Tristate Consortium

Primary: Compare the overall response rate at 9 months after study entry between the two study arms: 4 cycles of Pomalidomide/Dexamethasone followed by auto-SCT versus 9 cycles of Pomalidomide/Dexamethasone.
Secondary Objectives:
1. Determine the feasibility of a salvage auto-SCT after Pomalidomide/Dexamethasone reinduction in relapsed/refractory MM.
2. Determine the Overall survival and progression free survival.
3. Compare the time to next treatment on both treatment arms.
4. Compare the rate of minimal residual disease by flow cytometry or PCR clonal analysis at 9 months after registration between treatment arms.
5. Determine the safety of maintenance single agent pomalidomide.
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021208

AML Therapy with Irradiated Allogeneic Cells

Efficacy of allogeneic irradiated cells as consolidation therapy for patients with AML after fludarabine-cytarabine induction chemotherapy for patients with relapsed or refractory AML, age > 60 years old.
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081301

A Phase II, Randomized, Three-Arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients with Prostate Cancer with a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy

The primary endpoint for each cohort is progression-free survival (PFS) at 18 months from the start of randomization (PSA0). PFS is defined as an undetectable (less than or equal to 0.05 ng/mL) PSA with a non-castrate level of testosterone (greater than 150 ng/dL). Pathological lymph nodes (whether target or non-target) must also have reduction in short axis to less than 10mm (Compelte Response per RECIST) in order to meet the criteria for PFS.
Secondary endpoints: (1) PSA response rate (Percentage of patients with an undetectable PSA at 8 months from PSA0). (2) Effects of each arm on overall quality of life, with particular attention to libido, potency, anxiety, depression, hot flashes and fatigue. (3) Frequency and intensity of non-hematologic adverse events. (4) Testosterone and leuteinizing hormone (LH) recovery rates.
Tertiary endpoint: Correlative tissue analysis with clinical outcomes while on study treatment.
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020803

A Randomized Phase II Study of Nuclear Factor-kappa B (NF-kB) Inhibition During Induction Chemotherapy for Patients with Acute Myelogenous Leukemia (AML)

This trial will determine if salicylate-mediated NF-kB suppression results in suppression of NF-kB target gene expression and/or chemotherapy drug efflux in AML cells. If inhibition of these biologically relevant endpoints can be demonstrated in > 50% of patients, we will propose a phase III multi-institutional study to determine the effects of salicylate on complete remission rates.
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110811

COG-AALL0631: A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND #76431; NSC #617807)

We want to find out if adding lestaurtinib to standard therapy for Intermediate and High Risk infants with ALL will result in better treatment outcomes than standard chemotherapy alone. Since lestaurtinib only targets leukemia cells, it is hoped that the side effects of lestaurtinib will be less than for standard chemotherapy drugs. Although lestaurtinib is investigational and has not been approved by the FDA, it has been shown to be well-tolerated in children and adults. The side effects of lestaurtinib in infants are not known because the drug hasn't been evaluated in infants yet.

The goal of Part 1 of the study is to find the dose of lestaurtinib that is safe and that can turn off the FLT3 gene when given to Intermediate and High Risk infants with ALL.

During Part 1 of the study, lestaurtinib will be given to Intermediate and High Risk patients only at a limited number of cancer treatment centers. The Cancer Institute of New Jersey is NOT one of these centers. Therefore subjects will receive the combination chemotherapy treatment without lestaurtinib.

Part 2 of this study will only be undertaken if Part 1 of the study successfully finds a dose of lestaurtinib that is safe and can turn off the FLT3 gene. In Part 2 of the study, the researchers will try to find out how helpful lestaurtinib is in getting rid of cancer in infants with Intermediate and High Risk. Subjects participating in Part 1 of the study will not participate in Part 2 of the study.

The goal of Part 2 of the study is to find out the effects, good and/or bad, of lestaurtinib given in combination with standard chemotherapy in treating Intermediate and High Risk infants with ALL.
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111007

COG-AALL0932: Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)

1.To determine if a Maintenance regimen containing weekly oral methotrexate at 40 mg/m2/week will result in an improved disease free survival compared to that containing weekly oral methotrexate at 20 mg/m2/week in the average risk subset of patients with Standard Risk B-precursor ALL.
2. To determine whether a reduced-pulses Maintenance regimen with vincristine/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the average risk subset of patients with Standard Risk B-precursor ALL.
3.To confirm that patients in the low risk subset of Standard Risk B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5-year DFS of at least 95%
with either a P9904-based regimen that includes 6 courses of intermediate dose (1 g/m2 over 24 hours) methotrexate without alkylating agents or anthracyclines or an outpatient based regimen identical to that of average risk patients with vincristine/dexamethasone pulses at 12 week intervals during maintenance
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011104

NMDP 10-CBA: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications

Primary: to examine the incidence of neutrophil recovery of greater than or equal to 500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.
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051201

TED12471: A Phase 1 dose-escalation study of the safety and pharmacokinetics of a tablet formulation of SAR245409 administered daily to patients with solid tumors or lymphoma

Primary objective
To evaluate the safety and tolerability of SAR245409 administered
as a tablet formulation on 2 treatment schedules (once daily [QD]
and twice daily [BID] dosing) in patients with solid tumors or
lymphoma
Secondary objectives
To evaluate the plasma pharmacokinetics (PK) of oral administration
of SAR245409 given as a tablet formulation on QD and BID
treatment schedules in patients with solid tumors or lymphoma
To obtain preliminary information on the effect of food on the plasma
PK of oral administration of SAR245409 as a tablet formulation in
patients with solid tumors or lymphoma
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111109

COG AHEP0731: Treatment of Children with All Stages of Hepatoblastoma

1.1.2
Stage I hepatoblastoma (non-pure fetal histology [PFH]), non-small cell undifferentiated [SCU]) and Stage II (non-SCU) is a highly curable disease with 2 cycles of adjuvant cisplatin, 5-fluorouracil, and vincristine (C5V).

1.1.3
The addition of doxorubicin to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma will be feasible and associated with acceptable levels of toxicity.

1.1.4
The use of vincristine and irinotecan in an upfront window for children with high-risk, metastatic hepatoblastoma will improve the response rate in this group of children.

1.1.5
Referral for orthotopic liver transplant (OTL) is feasible in a cooperative group setting in children with hepatoblastoma designated as potentially unresectable following central surgical review and staging according to the PRE TEXT (Pretreatment Extent of Disease) grouping system.

1.2 Primary Aims

1.2.1
To estimate the EFS in children with Stage I (non-PFH, non-SCU) and Stage II (non SCU) hepatoblastoma treated with surgical resection followed by 2 cycles of C5V.

1.2.2
To determine the feasibility and toxicity of adding doxorubicin to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma.

1.2.3
To estimate the response rate to vincristine and irinotecan in previously untreated children with high-risk, metastatic hepatoblastoma.

1.2.4
To determine whether timely (between diagnosis and end of second cycle of chemotherapy) consultation with a treatment center with surgical expertise in major pediatric liver resection and transplant can be achieved in 70% of patients with potentially unresectable hepatoblastoma.

1.2.5
To foster the collection of tumor tissue and biologic samples to facilitate translational research and to provide data that may aid in risk-adapted approaches for subsequent clinical trials.
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111104

COG-AAML1031: A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND#69896, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD

1. To compare event free survival (EFS) and overall survival (OS) in patients with de novo acute myeloid leukemia (AML) without high allelic ratio FLT3/ITD+ mutations who are randomized to standard therapy versus bortezomib/standard combination therapy.
2, To determine the feasibility of combining bortezomib with standard chemotherapy in patients with de novo AML.
3. To compare the OS and EFS of high risk patients treated with intensive Induction II with historical controls from AAML03P1 and AAML0531. 1.1.4 To determine the feasibility of combining sorafenib with standard chemotherapy in patients with de novo high allelic ratio FLT3/ITD+ AML.
4. Secondary Objectives 1.2.1 To assess the anti-leukemic activity of sorafenib in patients with de novo high allelic ratio FLT3/ITD+ AML. 1.2.2 To compare the percentage of patients converting from positive MRD to negative MRD after Intensive Induction II with historical controls from AAML03P1 and AAML0531.
5. To compare OS, disease free survival (DFS), cumulative incidence of relapse, and treatment related mortality from end of Intensification I between patients allocated to best allogenic donor stem cell transplant (SCT) and comparable patients on AAML0531 who did not receive allogenic donor SCT.
6. To compare OS, DFS, cumulative incidence of relapse, treatment related mortality, and severe toxicity between patients allocated to matched family donor SCT on AAML1031 and AAML0531. 1.2.5 To assess the health-related quality of life (HRQOL) of patients treated with chemotherapy and stem cell transplant (SCT) for AML.
7. To compare the changes in shortening fraction/ejection fraction over time between patients treated with and without dexrazoxane.
8. To refine the use of minimal residual disease (MRD) detection with 4-color flow cytometry.
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011201

CC-122-ST-001: A Phase IA/IB, Multi-center,Open-Label, Dose Finding Study To Assess The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotrophic Pathway modifier CC-122 administered orally to subjects with advanced solid tumors, NHL and Multiple Myeloma.

Primary Objectives:
1. To determine the safety and tolerability of CC-122 given orally and to define the non-tolerable dose, MDT and the recommended phase 2 dose.
2. To determine the PK and extent of urinary excretion of CC-122.
Secondary Objectives:
1. Preliminary assessment of the anti-tumor activity of CC-122.
2. To determine the CNS penetration of CC-122.
3. To evaluate the PD effects of CC-122 on gene expression, cytoskeletal structure and cell surface organization in peripheral blood cell components.
4. To evaluate modulation of circulating cytokines in the plasma.
5. To evaluate modulation of immune effector cells and their subtypes in peripheral blood.
6. To evaluate the modulation of cytokine production in ex vivo LPS and anti-CD3 stimulated peripheral blood.
7. To determine the plasmacogenomic relationship between tumor gene sequence or copy number and response.
8. To explore the relationship between PK and PD effects of CC-122.
9. To explore the effect of CC-122 on biomarkers of angiogenesis in pre-and during treatment tumor biopsies when available.
10. To characterize the principle metabolites of CC-122 in plasma and urine.
11.To determine the PK of CC-122 anantiomers in urine and plasma.
12. To assess relationship between renal function and the PK of CC-122.
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021204

PF-05208773: An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator's Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)

PRIMARY: To compare the hematological remission, defined as CR (both CR and CRi), reported by the external independent adjudication committee, in patients with relapsed/refractory ALL randomized to receive inotuzumab ozogamicin (Arm A) versus patients randomized to receive the active comparator (Arm B).

SECONDARY: To compare the following between the two treatment arms:

1.Overall survival (OS) of patients with relapsed/refractory ALL.
2.Duration of response (DoR);
3.Progression-free survival (PFS);
4.Rate of stem-cell transplantation in patients;
5.To characterize the safety and tolerability including the rate of VOD/SOS followingallogeneic stem cell transplant;
6.To assess minimal residual disease levels and cytogenetics in patients achieving a CR/CRi;
7.To determine the population pharmacokinetic parameters of inotuzumab and confirm sources of exposure variability;
8.To compare patient-reported health-related quality of life (HRQOL) and patient-reported health status between treatment arms.
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111204

COG-ANHL1131: Intergroup Trial for Children or Adolescents with B-cell Non-Hodgkin Lymphoma (NHL) or Mature B-cell Leukemia (B-AL): Evaluation of Rituximab Efficacy and Safety in High Risk Patients

1. For patients with advanced stage B-Cell NHL/B-AL to test whether adding 6 injections of rituximab to standard LMB therapy increases the event free survival
2. For patients with PMLB, to evaluate the event free survival following treatment with DA-EPOCH-rituximab
3. To evaluate potential diagnostic value of MRD in this population
4. To obtain data on PET scans in childhood Bcell NHL
5. To characterize pharmacokinetics of rituximab in combination with LMB therapy
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111208

COG ACCL0934:A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

1. To determine if levofloxacin given prophylactically during periods of neutropenia to patients being treated for AL or undergoing SCT will decrease the incidence of bacteremia

2. To determine the effect of prophylaxis on the incidence of F+N, severe infection and death from bacterial infection

3. Assess safety, with specific focus on musculoskeletal disorders

4. Assess impact on bacterial resistance
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021302

ECOG E2906: Phase 3 Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age >= 60 Years)

Primary Objective
2.1.1 To evaluate the effect of clofarabine induction and consolidation therapy on overall survival in comparison with standard therapy (daunorubicin & cytarabine) in newly-diagnosed AML patients age ? 60 years.
2.2 Secondary Objectives
2.2.1 To evaluate complete remission (CR) rates, duration of remission, and toxicity/treatment-related mortality of clofarabine in comparison with standard therapy (daunorubicin & cytarabine) in newly-diagnosed AML patients age >60 years.
2.2.2 To evaluate the feasibility of consolidation with reduced-intensity conditioning and allogeneic hematopoietic stem cell transplantation from HLA-identical donors in select patients age 60-69 years who achieve a response to induction therapy, including the incidence of successful engraftment, acute and chronic graft-versus-host disease, transplant-related mortality, and its impact on overall survival in comparison to patients receiving chemotherapy.
2.2.3 To evaluate the duration of remission and disease-free survival of patients in complete remission following completion of consolidation therapy who are subsequently randomized to receive scheduled low-dose decitabine maintenance in comparison with observation.
Other Objectives include examination of several molecular correlates including methylation profiles, p-glycoprptein and CXCr4 expression, analyzing somatic mutations.
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021303

CC-486-AML-001: A Phase 3, Randomized, Double-Bind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission

Objectives
Primary Objective:
The primary objective of the study is to demonstrate if maintenance therapy with oral azacitidine improves overall survival (OS) compared with placebo in subjects with AML, age ? 55 years, who have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after induction with intensive chemotherapy with or without consolidation
chemotherapy.
Secondary Objectives:
The secondary objectives of the study are:
- To determine relapse-free survival (RFS);
- To determine safety, tolerability; and
- To determine the effect of oral azacitidine compared with placebo on health-related quality-of-life (HRQoL) and healthcare resource utilization.
Exploratory objectives:
The exploratory objectives of the study are:
- To determine complete cytogenetic remission (CRc) rate;
- To evaluate molecular and/or cellular markers in the bone marrow post-induction and during maintenance therapy that may be predictive of clinical outcomes with therapy (placebo or oral azacitidine), including OS and RFS, following CR/CRi; and
- To evaluate exploratory HRQoL measures
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021301

M13-982: A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion

Primary objective: The primary objective of this study is to evaluate the efficacy of ABT-199
monotherapy in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) harboring the
17p deletion. Efficacy will be measured by overall response rate (ORR).
Secondary objectives: The secondary objectives are to evaluate the duration of response,
progression-free survival (PFS), time to progression (TTP), overall survival (OS) and percent of subjects
who move on to stem cell transplant. The safety and tolerability of ABT-199 in subjects with relapsed
or refractory CLL harboring 17p deletion will also be evaluated.
Exploratory objectives: Time to next anti-CLL treatment (TTNT) will be evaluated. Minimal residual
disease (MRD) will be assessed in the peripheral blood and bone marrow (BM) either by flow cytometry
or real-time PCR. Pharmacokinetics, pharmacogenetics and biomarkers may also be evaluated as
exploratory objectives. Health Economic and Patient-Reported Outcome Measures will include the
MDASI (measure of patient reported symptoms), the EORTC QLQ-C30 and EORTC QLQ CLL16 (a
measure of health related quality of life specific to CLL) and the EQ-5D-5L (measure of general health
status) and EQ-5D-VAS.
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011301

GS-US-313-0125: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Primary Objective:To evaluate the effect of the addition of GS-1101 to B/R on PFS in subjects with previously treated iNHL

Secondary Objectives:
To evaluate the effect of the addition of GS-1101 to B/R on the onset, magnitude, and duration of tumor control
-To assess the effect of the addition of GS-1101 to B/R on measures of subject well-being, including OS, HRQL, and performance status
-To assess the effects of the addition of GS-1101 to B/R on disease-associated biomarkers
-To characterize exposure to study treatment as determined by treatment administration with each of the therapeutic agents and evaluation of GS-1101 plasma concentrations over time
-To describe the safety profile observed with the addition of GS-1101 to B/R
-To estimate health resource utilization associated with the addition of GS-1101 to B/R
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111304

COG-ANBL12P1 Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients with Newly Diagnosed High Risk Neuroblastoma: A Groupwide Pilot Study

1.To determine if the acute toxicity of an autologous stem cell transplant with a busulfan/melphalan (BuMel) based regimen is tolerable when given as
Consolidation therapy for high-risk neuroblastoma.

2.To determine the incidence of non-hematologic organ toxicity (Grade 3 and higher) and all causes of mortality in patients undergoing autologous stem cell transplant with a BuMel based regimen followed by local radiotherapy for the treatment of high-risk neuroblastoma.

3. To describe response rates, event-free survival (EFS), and overall survival (OS) for patients undergoing Induction therapy followed by Consolidation with myeloablative BuMel preparative regimen and local radiotherapy for the treatment of high-risk neuroblastoma.

4.To correlate busulfan pharmacokinetics with non-
hematologic toxicity following a BuMel based autologous transplant regimen
and event-free survival and overall survival

5.To determine the feasibility of performing Curie scores in real time, as assessed by central scan committee review of a 123 I-MIBG scan obtained after Cycle 4 of Induction therapy.

6. To examine the concordance between central reviewers and institutional reviewers in performing Curie scoring at diagnosis and after Cycle 4 of Induction therapy.

7. To determine the feasibility of detecting aberrations in the Anaplastic Lymphoma Kinase (ALK)gene in tumors obtained at the time of diagnosis in patients with high-risk neuroblastoma.

8.To determine the feasibility of performing molecular profiling of neuroblastoma tumors obtained at the time of diagnosis in patients with high
-risk neuroblastoma.

9. To correlate melphalan pharmacokinetics with non-hematologic toxicity following a BuMelbased autologous transplant regimenand event-
free survival and overall survival
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021310

IPI-145-07: A Phase 3 Study of IPI-145 versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

PRIMARY OBJECTIVE
The primary objective of this trial is to examine the efficacy of IPI-145 monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory CLL or SLL. PFS is the primary endpoint.

SECONDARY OBJECTIVES
To determine the safety of IPI-145 in subjects with CLL or SLL
To evaluate the PK of IPI-145 and, if applicable, its metabolite(s)

EXPLORATORY OBJECTIVES
To evaluate the health-related quality of life (QOL) of subjects
To evaluate pharmacodynamic biomarkers of IPI-145
To evaluate biomarkers that may predict IPI-145 clinical activity and/or safety
To evaluate mechanisms of resistance in subjects who exhibit disease progression while
being treated with IPI-145 and ofatumumab
To evaluate genomic features of tumors predictive of response in subjects treated with IPI-
145 and ofatumumab
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011304

PCI-32765DBL3001: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

The primary objective is to evaluate if the addition of ibrutinib to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) prolongs event-free survival (EFS) compared with R-CHOP alone in subjects with newly diagnosed non-GCB DLBCL.

The secondary objectives are to:
Evaluate PFS
Evaluate overall survival
Evaluate CR rate
Evaluate patient-reported lymphoma symptoms and concerns as measured by the Lym
subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)

Evaluate the treatment benefit of ibrutinib in subjects with the ABC subtype based on GEP

Characterize the pharmacokinetics of ibrutinib and to explore the potential relationships between ibrutinib metrics of exposure with relevant clinical or biomarker information

Evaluate the safety of ibrutinib when combined with R-CHOP
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021311

IPI-145-12: A Study of IPI-145 and Ofatumumab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI-145-07

Extension study of CINJ # 021310 (IPI-145-07)
Primary Objectives:
- To examine the efficacy of IPI-145 monotherapy in subjects with
Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic
Lymphoma (SLL) who experienced disease progression after
treatment with ofatumumab in Study IPI-145-07
- To examine the efficacy of ofatumumab monotherapy in subjects
who experienced disease progressionafter treatment with IPI-145 or
ofatumumab in Study IPI-145-07

Secondary Objective:
-To determine the safety of IPI-145 and ofatumumab in subjects with
CLL and SLL who experienced disease progression after treatment
with IPI-145 in Study IPI-145-07
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111305

COG ANHL12P1 A Randomized Phase II study of Brentuximab Vedotin (NSC# 749710) and Crizotinib (NSC# 749005) in Patients with Newly Diagnosed Anaplastic Large Cell Lymphoma (ALCL) IND #117117

1. To determine the
tolerability of brentuximab vedotin given in combination with
standard chemotherapy (ALCL99) and to determine the tolerability of crizotinib
given in combination with chemotherapy (ALCL99).
2.
To estimate the Event Free Survival of Arm Brentuximab and standard chemotheray and Crizotinib and standard chemotherapy and contrast these to historical control data.

3. To determine the prognostic significance of minimal disseminated
disease (MDD) at diagnosis and minimal residual disease (MRD)
as measured by RT - polymerase chain reaction (PCR)in peripheral blood
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021305

PCI-32765MCL3002: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

Primary objective: To evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of PFS in subjects with newly diagnosed MCL who are 65 years of age or older

Secondary Objectives:
- To evaluate overall survival
- To evaluate the CR rate and overall response rate (CR+PR)
- To evaluate patient-reported lymphoma symptoms and concerns as measured by the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
- To evaluate the minimal residual disease (MRD) negative rate
- To evaluate duration of response
- To evaluate time-to-next treatment (TTNT)
- To evaluate the safety of ibrutinib when combined with BR
- To characterize the pharmacokinetics of ibrutinib and explore the potential relationships between ibrutinib metrics of exposure with relevant clinical, pharmacodynamic, or biomarker information
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051302

JNJ-42756493: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, in Subjects With Advanced or Refractory Solid Tumors or Lymphoma

1) To determine a safe and biologically active Phase 2 dose (recommended Phase 2 dose [RP2D]) for JNJ-42756493 (Part 1 Dose Escalation)
2) To evaluate the feasibility of treating a molecularly-defined subset of subjects with squamous celllung cancer and subjects with breast cancer with JNJ-42756493 at the RP2D (Part 2 Dose Expansion)
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021403

CALGB A041202: A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

Primary Objective
To determine whether progression free survival (PFS) is superior after therapy with bendamustine in combination with rituximab, ibrutinib alone, or ibrutinib in combination with rituximab in patients age 65 or older with previously untreated CLL
2.2 Secondary Objectives
2.2.1 To determine 2-year PFS in each of the three treatment arms
2.2.2 To determine which treatment arm produces superior overall survival (OS)
2.2.3 To determine the complete response (CR) rate, complete and nodular partial response (CR/nPR) rate, and overall response (PR+nPR+CR) rate (ORR) among the three treatment arms and compare these arms
2.2.4 To determine the impact of MRD-negative disease at time of CR documentation and at 2 years on PFS and OS in each of the treatment arms
2.2.5 To determine duration of response after each of the three treatments and compare these treatment arms
2.2.6 To determine toxicity and tolerability of the three treatment regimens
2.2.7 To determine response and PFS of patients initially on the bendamustine in combination with rituximab arm who cross over to ibrutinib
2.2.8 To determine whether baseline cytogenetic markers, Zap-70 methylation, IgVH mutational status, or select DNA mutations predict outcomes or time to response in these three arms
2.2.9 To determine whether local FISH results for del(11q22.3) and del(17p13.1) are consistent with central analysis.
2.2.10 To determine whether baseline microRNA and gene expression markers are correlated with clinical outcomes of interest (e.g. progression-free and alive at 2 years versus not), as well as to explore changes in microRNA expression from baseline to post-treatment time points, with a focus on those with persistent lymphocytosis and relapse
2.2.11 To determine whether eradication of MRD predicts longer duration of response with standard therapy and ibrutinib-based regimens
2.2.12 To describe the baseline functional status, comorbid medical conditions, and number of medications of older CLL patients who meet criteria for therapy
2.2.13 To determine how functional status changes with therapy using baseline to 3-month evaluation and end-of-study/2-year evaluation; to determine whether this change is different among the treatment groups
2.2.14 To determine whether geriatric assessment variables known to be associated with chemotherapy toxicity in other disease groups can also predict therapy-associated toxicity in the CLL population
2.2.15 To assess whether the FCGR3A polymorphism (rs396991) is correlated with depth of response (MRD status) to ibrutinib plus rituximab after 6 cycles, with secondary endpoints CR rate, rapidity of response, and progression-free survival (PFS)
2.2.16 To assess whether C1QA polymorphism (rs172378) is correlated with MRD status, CR rate, rapidity of response, and PFS
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111102

COG ACCL0933: A Randomized Open Label Trial of Caspofungin versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

To determine if prophylaxis with caspofungin administered during periods of neutropenia following chemotherapy for acute myeloid leukemia is associated with a lower incidence of proven or probable invasive fungal infections compared with fluconazole.

To determine sensistivity, specificity of biweekly galactomannan and beta-D glucan testing

To test association between single nucleotode polymorphisms in genes involved in innate immunity
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