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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

Primary Purpose

Leukemia, Myelocytic, Acute

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

gemtuzumab ozogamicin

ATRA plus 6-MP and MTX

About this trial

This is an interventional treatment trial for Leukemia, Myelocytic, Acute focused on measuring Oncology comparison study

Eligibility Criteria

18 Years - 61 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

2 doses of gemtuzumab ozogamicn administered at monthly intervals

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

Outcomes

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00962767

First Posted

August 18, 2009

Last Updated

August 19, 2009

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00962767

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

May 2002 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myelocytic, Acute

Keywords

Oncology comparison study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

2 doses of gemtuzumab ozogamicn administered at monthly intervals

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

gemtuzumab ozogamicin

Other Intervention Name(s)

Arm A

Intervention Description

2 IV infusions 6 mg/m2 administered monthly

Intervention Type

Drug

Intervention Name(s)

ATRA plus 6-MP and MTX

Other Intervention Name(s)

Arm B

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

61 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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. Male and female patients age > 18 years and < 61 years. Exclusion criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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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