A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
UCB Pharma
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: March 26, 2012
Last updated: March 11, 2016
Last verified: March 2016
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: inotuzumab ozogamicin
Drug: FLAG (fludarabine, cytarabine and G-CSF)
Drug: HIDAC (high dose cytarabine)
Drug: cytarabine and mitoxantrone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Response to therapy (percentage of patients achieving a complete response and complete response with incomplete platelet and/or neutrophil recovery). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Rate of stem-cell transplantation: percentage of patients having stem-cell transplant [ Time Frame: Baseline to 8 months ] [ Designated as safety issue: No ]
  • Minimal residual disease (MRD): number of leukemic cells in bone marrow after CR/CRi [ Time Frame: Baseline to 7 months ] [ Designated as safety issue: No ]
  • Cytogenetics: quantitate t(9;22), MLL, and IGH rearrangements in leukemia cells [ Time Frame: Baseline to 7 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quality of life: EQ-5D = EuroQual -5D Health Questionnaire [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 325
Study Start Date: August 2012
Estimated Study Completion Date: February 2017
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: 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: Arm B Drug: 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
Drug: HIDAC (high dose cytarabine)
cytarabine 3 g/m^2 IV every 12 hours for up to 12 times
Drug: 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CD22 expression
  • Adequate liver and renal functions

Exclusion Criteria:

  • Isolated extramedullary disease
  • Active Central Nervous System [CNS] disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564784

  Show 197 Study Locations
Sponsors and Collaborators
UCB Pharma
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01564784     History of Changes
Other Study ID Numbers: B1931022  2011-005491-41 
Study First Received: March 26, 2012
Last Updated: March 11, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 24, 2016