Clinical trial · Interventional
Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
A Phase I/II Study to Determine Safety and Efficacy of Arsenic Trioxide (Trisneox™) in Combination With Imatinib (STI571, Gleevec™) in Patients With Chronic Myelogenous Leukemia in Accelerated or Blastic Phase Disease or Ph+ Acute Lymphoblastic Leukemia
- 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, such as arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining arsenic trioxide with imatinib mesylate may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide when given with imatinib mesylate and to see how well they work in treating patients with accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic 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 |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following:
* Chronic myelogenous leukemia (CML) in one of the following phases:
* Blastic phase\*
* Accelerated phase\*
* No appropriate donors for stem cell transplantation NOTE: \*Must have received high-dose (600-800 mg/day) imatinib mesylate of no more than 3 months duration
* Acute lymphoblastic leukemia
* Philadelphia chromosome positive by cytogenetic confirmation
* Patients with only bcr-abl-positive disease by polymerase chain reaction are not eligible
* \> 10% blasts in the bone marrow
* No isolated extramedullary disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 2 times ULN
* INR and PTT ≤ 1.5 times ULN (except for patients on anticoagulation therapy)
Renal
* Creatinine ≤ 2 times ULN
Cardiovascular
* Baseline QTc intervals \< 480 ms
* No chronic arrhythmias
* No active coronary artery disease
Other
* No chronic electrolyte abnormalities
* No prior non-compliance to medical regimens
* No patients who are considered potentially unreliable
* No active serious infection
* No other active malignancies except superficial epithelial cancers
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior peripheral blood stem cell or bone marrow transplantation
Chemotherapy
* Prior hydroxyurea allowed
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* More than 4 weeks since prior major surgery and recovered
Other
* Prior anagrelide allowed
* No concurrent warfarin for therapeutic anticoagulation
* Concurrent low molecular weight heparin is allowedReferences
Publications (0)
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