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)

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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.

Protocol Number021204
Principal InvestigatorKevin David
PhasePhase III
ScopeNational
Applicable Disease SitesLymphoid Leukemia
Therapies InvolvedChemotherapy single agent systemic
Therapy (NOS)
Drugs InvolvedFLUDARABINE
CYTARABINE
Inotuzumab ozogamicin (CMC-544)
MITOXANTRONE
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.