Overview

This trial is active, not recruiting.

Condition acute lymphoblastic leukemia
Treatments inotuzumab ozogamicin, flag (fludarabine, cytarabine and g-csf), hidac (high dose cytarabine), cytarabine and mitoxantrone
Phase phase 3
Target CD22
Sponsor Pfizer
Collaborator UCB Pharma
Start date August 2012
End date March 2016
Trial size 325 participants
Trial identifier NCT01564784, 2011-005491-41, B1931022

Summary

This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
inotuzumab ozogamicin
Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
(Active Comparator)
flag (fludarabine, cytarabine and g-csf)
Dose: cytarabine 2.0 g/m^2/day IV days 1-6 fludarabine30 mg/m^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4
hidac (high dose cytarabine)
cytarabine 3 g/m^2 IV every 12 hours for up to 12 times
cytarabine and mitoxantrone
mitoxantrone 12 mg/m^2 IV days 1-3 cytarabine 200 mg/m^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4

Primary Outcomes

Measure
Response to therapy (percentage of patients achieving a complete response and complete response with incomplete platelet and/or neutrophil recovery).
time frame: 6 months
Overall Survival
time frame: Baseline to 24 months

Secondary Outcomes

Measure
Progression free survival
time frame: Baseline to 24 months
Volume of distribution (Vd) for inotuzumab ozogamicin in serum
time frame: Cycle 1, Days 1, 3, 8 and 15; Cycle 2 , Days 1 and 8; Cycle 4, Days 1 and 8
Systemic clearance (CL) for inotuzumab ozogamicin in serum
time frame: Cycle 1, Days 1, 3, 8 and 15; Cycle 2 , Days 1 and 8; Cycle 4, Days 1 and 8
Duration of response
time frame: Baseline to 24 months
Rate of stem-cell transplantation: percentage of patients having stem-cell transplant
time frame: Baseline to 8 months
Minimal residual disease (MRD): number of leukemic cells in bone marrow after CR/CRi
time frame: Baseline to 7 months
Cytogenetics: quantitate t(9;22), MLL, and IGH rearrangements in leukemia cells
time frame: Baseline to 7 months
Quality of life: . EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer. Quality of Life Questionnaire, Core-30
time frame: Baseline to 6 months
Quality of life: EQ-5D = EuroQual -5D Health Questionnaire
time frame: Baseline to 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - CD22 expression - Adequate liver and renal functions Exclusion Criteria: - Isolated extramedullary disease - Active Central Nervous System [CNS] disease

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pfizer.