Clinical trial · Interventional
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 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)
NCT00962767CI-TRIAL-00002562completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myelocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATRA plus 6-MP and MTX | Drug | — | UNRESOLVED |
| gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- a
- description
- 2 doses of gemtuzumab ozogamicn administered at monthly intervals
- interventionNames
- Drug: gemtuzumab ozogamicin
- type
- ACTIVE_COMPARATOR
- label
- b
- description
- 2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX)
- interventionNames
- Drug: ATRA plus 6-MP and MTX
Primary outcomes (1)
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 61 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.