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:
Collaborator:
Union Chimique Belge
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01564784
First received: March 26, 2012
Last updated: March 19, 2015
Last verified: March 2015

March 26, 2012
March 19, 2015
August 2012
October 2014   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01564784 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall Survival [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
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)

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
  • 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
  • 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
  • Experimental: Arm A
    Intervention: Drug: inotuzumab ozogamicin
  • Active Comparator: Arm B
    Interventions:
    • Drug: FLAG (fludarabine, cytarabine and G-CSF)
    • Drug: HIDAC (high dose cytarabine)
    • Drug: cytarabine and mitoxantrone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
325
March 2017
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • CD22 expression
  • Adequate liver and renal functions

Exclusion Criteria:

  • Isolated extramedullary disease
  • Active Central Nervous System [CNS] disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   China,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Singapore,   Spain,   Sweden,   Taiwan,   United Kingdom
Belgium,   Croatia,   Serbia,   Slovakia
 
NCT01564784
B1931022, 2011-005491-41
Yes
Pfizer
Pfizer
Union Chimique Belge
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP