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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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00962767
First received: August 18, 2009
Last updated: August 19, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Leukemia, Myelocytic, Acute
 Drug: gemtuzumab ozogamicin
Drug: ATRA plus 6-MP and MTX
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 168
Study Start Date: May 2002
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: a
2 doses of gemtuzumab ozogamicn administered at monthly intervals
 Drug: gemtuzumab ozogamicin
2 IV infusions 6 mg/m2 administered monthly
Other Name: Arm A
Active Comparator: b
2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX)
 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

  Eligibility

Ages Eligible for Study:   18 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962767

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00962767     History of Changes
Other Study ID Numbers: 0903X-101128
Study First Received: August 18, 2009
Last Updated: August 19, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Oncology comparison study

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
 Neoplasms
Gemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013