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CompletedNCT00962767Updated Aug 20, 2009

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

A Phase 3 interventional study of gemtuzumab ozogamicin and ATRA plus 6-MP and MTX in Leukemia, Myelocytic, Acute, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to participants aged 18 Years to 61 Years. Per ClinicalTrials.gov, last updated 2009-08-20.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years to 61 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Leukemia, Myelocytic, Acute

Keywords

  • Oncology comparison study
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 168 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 61 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    a

    2 doses of gemtuzumab ozogamicn administered at monthly intervals

    Drug: gemtuzumab ozogamicin

  • 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

Interventions

  • Druggemtuzumab ozogamicin

    2 IV infusions 6 mg/m2 administered monthly

    Also known as: Arm A

  • DrugATRA 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

    Also known as: Arm B

06

What researchers measure

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.

    Time frame: 5 years

Secondary outcomes

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

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00962767
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Aug 20, 2009
Start date
May 2002
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Aug 20, 2009

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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