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Trial record 1 of 1 for:    B1931022
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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01564784
First Posted: March 28, 2012
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Pfizer
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • Overall Survival [ Time Frame: Baseline to 24 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 325
Study Start Date: August 2012
Estimated Study Completion Date: January 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CD22 expression
  • Adequate liver and renal functions

Exclusion Criteria:

  • Isolated extramedullary disease
  • Active Central Nervous System [CNS] disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564784


  Show 199 Study Locations
Sponsors and Collaborators
Pfizer
UCB Pharma
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01564784     History of Changes
Other Study ID Numbers: B1931022
2011-005491-41 ( EudraCT Number )
First Submitted: March 26, 2012
First Posted: March 28, 2012
Last Update Posted: October 16, 2017
Last Verified: January 2017

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