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

Leukemia, Myelocytic, Acute Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962767
• Other study ID #: 0903X-101128
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2009
• Last updated: August 19, 2009
• Start date: May 2002
• Est. completion date: December 2007

Study information

• Verified date: August 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 61 Years

Eligibility

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/RARa 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 a rearrangement in leukemic cells after successful RNA extraction and amplification of control gene.

3. Pretreated APL.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Promyelocytic, Acute

Intervention

Drug:
• gemtuzumab ozogamicin
2 IV infusions 6 mg/m2 administered monthly
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival.		5 years	Yes