|Protocol||Trial Name and Objective|
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.
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.
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.
A Pilot Study of Romidepsin for Therapy of Graft-versus-Host Disease
1.1 Primary Objective:
To determine if romidepsin should be developed as a therapy for patients with steroid-refractory GVHD.
1.2 Primary Hypothesis:
The hypothesis is that romidespin will reduce GVHD in some patients with steroid refractory disease. If greater than or equal to 2/10 patients with either aGVHD or cGVHD demonstrate a PR, a formal phase 2 study will be developed.
Retrospective Comparative Analysis of Hematologic Toxicities in Patients Receiving Chemo-Radiotherapy in Rectal Cancers Versus Chemotherapy in Colon Cancers.
To quantify bone marrow toxicity after radiation therapy in rectal cancer patients compared to bone marrow toxicity without radiation therapy in colon cancer patients.
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
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.
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.
COG AHEP0731: Treatment of Children with All Stages of Hepatoblastoma
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).
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.
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.
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
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.
To determine the feasibility and toxicity of adding doxorubicin to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma.
To estimate the response rate to vincristine and irinotecan in previously untreated children with high-risk, metastatic hepatoblastoma.
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.
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.
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
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.
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.
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.
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
M13-982: A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects with Relapsed/Refractory or Previously Untreated 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.
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 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
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)
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).
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
MK-8228-001: A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Clinically Significant Human Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients
1) Objective: To evaluate the efficacy of MK-8228 in the prevention of clinically significant CMV infection through Week 24 (~6 months) post-transplant following administration of MK-8228 or placebo.
1) Objective: To evaluate the safety and tolerability of MK-8228.
2) Objective: To evaluate the efficacy of MK-8228 in the prevention of clinically significant CMV infection through Week 14 (~100 days) post-transplant.
3) Objective: To evaluate the efficacy of MK-8228 as assessed by time to onset of clinically significant CMV infection through Week 24 (~6 months) post-transplant.
4) Objective: To determine the incidence of CMV disease through Week 14 post -
transplant and Week 24 post-transplant.
5) Objective: To assess the incidence of anti-CMV pre-emptive therapy (PET) for CMV viremia through Week 14 post -transplant and Week 24 post-transplant.
1) Objective: To determine the incidence of CMV disease through Week 48 posttransplant.
2) Objective: To determine the incidence of all-cause mortality through Week 14 posttransplant, Week 24 post-transplant, and Week 48 post-transplant.
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)
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
13-006: An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (asparaginase Erwinia chrysanthemi)/Erwinase® (crisantaspase)Administered Following Hypersensitivity to E. coli Asparaginase in Young Adults with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
1. The primary objective of this study is to determine the proportion of subjects with 2-day nadir serum asparaginase activity (NSAA) levels (48-hour levels taken after the 5th dose) that are >= 0.1 IU/mL in the first 2 consecutive weeks of Erwinaze treatment.
2.To determine the proportion of subjects with 3-day NSAA levels (72-hour levels taken after the 6th dose) that are ? 0.1 IU/mL in the first 2 consecutive weeks of Erwinaze treatment
3. To describe the NSAA over time following repeated administration of Erwinaze
4.To evaluate the safety of Erwinaze in young adult subjects as follows:
5.To describe the incidence and severity of asparaginase-related toxicities
6.To measure the presence of anti-Erwinaze antibodies and neutralizing antibody
A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion
The primary objective of this study is:
h To evaluate the overall response rate (ORR) following treatment
with idelalisib (IDELA) plus rituximab in subjects with
previously untreated chronic lymphocytic leukemia (CLL) with
The secondary objectives of this study are:
h To evaluate the effect of the combination of IDELA and
rituximab on the onset, magnitude, and duration of disease
control, including duration of response (DOR), progression free
survival (PFS), and overall survival (OS)
h To evaluate the effect of the combination of IDELA and
rituximab on minimal residual disease (MRD)
h To describe the safety profile observed with the combination of
IDELA and rituximab
h To characterize exposure to study treatment with IDELA and
rituximab as determined by treatment administration and
evaluation of IDELA plasma concentrations over time
The exploratory objectives of this study are:
h To evaluate the effect of the combination of IDELA and
rituximab on measures of subject well-being and health-related
quality of life (HRQL)
h To assess the effects of the combination of IDELA and rituximab
on disease-associated biomarkers and to evaluate potential
mechanisms of resistance
AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy)
1 To compare EFS in patients with newly diagnosed T-ALL and T-LLy who are randomized to a modified ABFM backbone versus bortezomib plus the modified ABFM backbone.
2.To determine the safety and feasibility of modifying standard therapy for T-ALL and T-LLy based on the results of UKALL 2003, which includes a dexamethasone-based Induction, additional doses of pegaspargase (PEG-ASP) during Induction and Delayed Intensification (DI), and dexamethasone pulses during Maintenance therapy
3. To determine if prophylactic cranial radiation therapy (CRT) can be safely and effectively eliminated in the 85-90% of T-ALL patients classified asstandard or intermediate risk.
4.To determine the proportion of EOC MRD ? 0.1% T-ALL patients who become MRD negative (undetectable by flow cytometry) after intensification of chemotherapy, using three high risk (HR) BFM blocks, and to compare EFS between the patients who become MRD negative after the three HR BFM blocks and continue on chemotherapy with those who continue to have detectable MRD and are eligible for other treatment strategies, including hematopoietic stem cell transplant
Similarly, to compare the EFS between very high risk (Induction failure) T-LLy
patients treated with HR BFM intensification blocks who have partial or complete response (PR or CR) with those who do not respond (NR).
5. To investigate the prognostic significance of Day 29 BM MRD in T-LLy patients.
6. To determine if protein expression patterns can predict bortezomib response and drug resistance in T-ALL
7. To analyze and target relevant signaling pathways in T-ALL blasts, focusing on Early T cell Precursor ALL
R1979-HM-1333: An Open-label, Multi-center Phase I Study to Investigate the Safety and Tolerability of REGN1979, an anti-CD20 x anti-CD3 bispecific monoclonal antibody, in Patients with CD20+ B-cell Malignancies previously treated with CD20 directed antibody therapy.
The primary objective of the study is to assess the safety, tolerability, and dose-limiting toxicities (DLTs) of REGN1979 administered intravenously (IV).
The secondary objectives of the study are:
* To characterize the pharmacokinetic (PK) profile of REGN1979
* To assess the immunogenicity of REGN1979
* To study the preliminary antitumor activity of REGN1979 administered to patients with CD20+ B-cell malignancies (non-Hodgkin's lymphoma [NHL] and chronic lymphocytic leukemia [CLL]) previously treated with anti-CD20 antibody therapy.
o Minimal residual disease (MRD) assessments in patients with CLL
The exploratory objectives of the study are:
* To evaluate biomarkers that may correlate with mechanism of action, observed toxicity, and potential anti-tumor activity including, but not limited, to:
o Cytokine profiling
o Peripheral blood B-cell and T-cell subsets and immune phenotyping
o Changes in gene expression in peripheral blood
Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 8 - LEE011 for patients with CDK4/6 pathway.
1)To assess clinical benefit associated with LEE011 treatment based on
local investigator assessment.
2) For patients with solid tumors the assessment criteria will be RECIST 1.1
and will include responses of CR or PR or SD ? 16 weeks. For
hematologic tumors, other appropriate hematological response criteria will
apply and are included in the appendices.
Key Secondary objective:
1) To assess Overall Response (OR) of Partial Response (PR) or greater
based on local investigator assessment.
2) For patients with solid tumors, the assessment criteria will be RECIST 1.1
and will include responses of CR and/or PR. For hematologic tumors,
other appropriate hematological response criteria will apply and are
included in the appendices.
1) Progression-Free Survival (PFS) based on local investigator assessment
per RECIST 1.1 or other appropriate hematological response criteria
2) Overall Survival (OS)
3) Duration of Response (DOR) based on local investigator assessment per
RECIST 1.1 or other appropriate hematological response criteria
4) Safety and tolerability
1) To assess any relationship betweenCDK4/6 pathway activation and
response to treatment with LEE011
Gemtuzumab Ozogamicin Expanded Access Protocol For Treatment Of Patients In The United States With Relapsed/Refractory Acute Myelogenous Leukemia Who May Benefit From Treatment And Have No Access To Other Comparable/Aletrnative Therapy.
This expanded access protocol is designed in accordance with FDA 21 CFR 312.315
to allow compassionate access to Mylotarg for treatment of our single patient with AML who is thought to have the potential to derive clinical benefit and has exhausted other appropriate and reasonable treatment options. The objective of the protocol is to provide patients compassionate access to Mylotarg.
Therefore, there is no formal primary endpoint. Instead, safety information from
patients receiving Mylotarg in this setting will be carefully monitored, collected and
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