Clinical trial · Interventional
Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia
A Phase I/II Open-Label Study Of The Intravenous Administration Of Homoharringtonine (CGX-635) Salvage Therapy For The Treatment Of Refractory Acute Promyelocytic Leukemia
NCT00030355CI-TRIAL-00009801withdrawnPhase 1 / Phase 2ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of homoharringtonine in treating patients who have refractory 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Procedure | — | UNRESOLVED |
| homoharringtonine | Drug | Omacetaxine Mepesuccinate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety by physical examinations, vital signs, laboratory studies (routine hematology, clinical chemistry, pharmacokinetics, urinalysis, chest x-ray, and EKG), and solicited and unsolicited adverse events
- measure
- Efficacy by response to treatment
Secondary outcomes (5)
- measure
- Pharmacokinetics
- measure
- Duration of treatment response
- measure
- Survival
- measure
- Induction mortality
- measure
- Hospitalizations
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of acute promyelocytic leukemia confirmed morphologically and by t(15;17) translocation or molecular polymerase chain reaction * Refractory to tretinoin, anthracyclines, and arsenic-based therapy (including arsenic trioxide) and for which no other alternative therapy of higher priority is appropriate PATIENT CHARACTERISTICS: Age: * 12 and over Performance status: * Zubrod 0-3 Life expectancy: * More than 4 weeks Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 2.0 mg/dL * ALT no greater than 3 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease * No active ischemia * No other uncontrolled cardiac condition (e.g., angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure) * No myocardial infarction within the past 12 weeks Other: * No other concurrent illness that would preclude study * No other active malignancy * No uncontrolled active infection * No clinically significant screening serum chemistry results unless attributed to acute promyelocytic leukemia * No medical or psychiatric condition that would preclude informed consent or study therapy * HIV negative * HTLV-I and HTLV-II negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior or concurrent leukapheresis allowed Chemotherapy: * See Disease Characteristics * At least 15 days since prior systemic chemotherapy unless leukemia progression necessitates early therapy * No other concurrent systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * Recovered from prior therapy * At least 15 days since other prior antileukemic therapy unless leukemia progression necessitates early therapy * No other concurrent antileukemic therapy
References
Publications (0)
Data not yet available
No reference posted for this study.