Clinical trial · Interventional
Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia
Phase II Study Of Combined Modality Postremission Therapy As Determined By Molecular Response (Adaptive Regulation) In The Treatment Of Acute Promyelocytic Leukemia (APL)
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and monoclonal antibody in treating patients who have acute promyelocytic leukemia.
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 | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| lintuzumab | Biological | — | UNRESOLVED |
| tretinoin | Drug | Tretinoin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- reverse transcriptase-polymerase chain reaction negativity
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of acute promyelocytic leukemia by positive RT-PCR assay for PML/RAR-alfa rearrangement or a t(15;17) karyotype * Achieved clinical complete remission within the past 1-2 months * Prior induction therapy must have contained tretinoin * No other acute myeloid leukemia diagnosis PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2 mg/dL * Transaminases no greater than 3 times upper limit of normal Renal: * Creatinine less than 2 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * Ejection fraction normal or greater than 50% by echocardiogram or MUGA Other: * No other concurrent active malignancy * No other serious or life-threatening condition that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 4 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 1 week since prior retinoids Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior postremission therapy of any form
References
Publications (0)
Data not yet available