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Trial record 1 of 1 for:    NCT00962767
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Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission

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ClinicalTrials.gov Identifier: NCT00962767
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE August 18, 2009
First Posted Date  ICMJE August 20, 2009
Last Update Posted Date August 20, 2009
Study Start Date  ICMJE May 2002
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
The study will compare the 2 treatments in intermediate and high-risk APL patients and assess their efficacy in achieving first hematological complete remission and molecular remission. [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival. [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission
Official Title  ICMJE A Randomized Study of Two Doses Gemtuzumab Ozogamicin vs. A Two-year Maintenance With Atra Plus Chemotherapy as Post-consolidation Treatment for Intermediate and High-risk Adult Patients With Acute Promyelocytic Leukemia (Apl)
Brief Summary The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Myelocytic, Acute
Intervention  ICMJE
  • Drug: gemtuzumab ozogamicin
    2 IV infusions 6 mg/m2 administered monthly
    Other Name: Arm A
  • Drug: ATRA plus 6-MP and MTX
    6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO
    Other Name: Arm B
Study Arms  ICMJE
  • Experimental: a
    2 doses of gemtuzumab ozogamicn administered at monthly intervals
    Intervention: Drug: gemtuzumab ozogamicin
  • Active Comparator: b
    2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX)
    Intervention: Drug: ATRA plus 6-MP and MTX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2009)
168
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence of additional cytogenetic lesions is not considered an exclusion criterion) with intermediate and high risk disease.
  2. Male and female patients age > 18 years and < 61 years.

Exclusion criteria:

  1. Low risk patients (WBC < 10 x 109/L and platelets > 40 x 109/L).
  2. Absence of PML-RAR α rearrangement in leukemic cells after successful RNA extraction and amplification of control gene.
  3. Pretreated APL.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 61 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00962767
Other Study ID Numbers  ICMJE 0903X-101128
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

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