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

NCT00962767 | Completed Phase 3 DMC

• 1 other identifier: 0903X-101128
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia, Myelocytic, Acute

Keywords

Oncology comparison study

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (1)

• Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival.

  5 years

Study Arms (2)

a

EXPERIMENTAL

2 doses of gemtuzumab ozogamicn administered at monthly intervals

Drug: gemtuzumab ozogamicin

b

ACTIVE COMPARATOR

2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX)

Drug: ATRA plus 6-MP and MTX

Interventions

gemtuzumab ozogamicin DRUG

2 IV infusions 6 mg/m2 administered monthly

Also known as: Arm A

a

ATRA plus 6-MP and MTX DRUG

6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO

Also known as: Arm B

b

Eligibility Criteria

• Age: 18 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients age \> 18 years and \< 61 years.

You may not qualify if:

• Low risk patients (WBC \< 10 x 109/L and platelets \> 40 x 109/L).
• Absence of PML-RAR α rearrangement in leukemic cells after successful RNA extraction and amplification of control gene.
• Pretreated APL.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Gemtuzumab; Tretinoin; Mercaptopurine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 20, 2009
• Study Start: May 1, 2002
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 20, 2009

Record last verified: 2009-08