Clinical trial · Interventional
Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia
A Phase II Study of Arsenic Trioxide for Induction Therapy of Adult Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia and Previously Untreated Chronic Myeloid Leukemia With Blast Crisis
NCT00006092CI-TRIAL-00008149terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
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 II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arsenic Trioxide | Drug | Arsenic Trioxide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arsenic Trioxide Treatment
- description
- Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.
- interventionNames
- Drug: Arsenic Trioxide
Primary outcomes (1)
- measure
- Objective Rate of Response (ORR)
- timeFrame
- 2.5 years
- description
- Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following:
* Acute lymphoblastic leukemia
* Philadelphia chromosome (Bcr-abl) positive
* Refractory to initial therapy OR recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation
* Blastic phase chronic myelogenous leukemia
* Philadelphia chromosome (Bcr-abl) positive
* Previously untreated OR recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate
* Must not be eligible for bone marrow transplant
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.0 times upper limit of normal (ULN)
* AST/ALT no greater than 2 times ULN
Renal:
* Creatinine no greater than 2.0 times ULN
* Creatinine clearance greater than 70 mL/min
Cardiovascular:
* No uncontrolled angina
* No New York Heart Association class III or IV heart disease
* No second degree heart block without pacemaker
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
* HIV negative
* No uncontrolled infection or other serious concurrent illness
* No peripheral neuropathy
* No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR
* No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected
* Electrolyte imbalances must be corrected prior to study entry
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
* At least 28 days since prior chemotherapy
* At least 24 hours since prior hydroxyurea
* No prior arsenic trioxide
* No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS leukemia
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 28 days since prior radiotherapy
* No concurrent radiotherapy including for palliation
Surgery:
* Not specified
Other:
* At least 14 days since prior imatinib mesylate
* No other concurrent investigational agents
* No concurrent amphotericin BReferences
Publications (0)
Data not yet available
No reference posted for this study.