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
G-CSF
MITOXANTRONE
Inotuzumab ozogamicin (CMC-544)
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.