Clinical trial · Interventional
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT00006008CI-TRIAL-00010943completedPhase 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 II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Morphologically proven acute lymphoblastic leukemia (ALL) * Subtypes L1, L2, or L3 * Bone marrow morphology with greater than 25% lymphoblasts * ALL morphology and cytochemistry with myeloid markers eligible * Refractory to induction therapy or relapsed following chemotherapy or autologous blood or bone marrow transplantation * Any number of prior relapses allowed * No relapse following allogeneic transplantation * Prior CNS leukemia allowed if treated and currently disease-free PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 6 months Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT/SGPT no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN Renal: * Creatinine no greater than 2 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No significant active infection * No other medical conditions that would likely decrease life expectancy * No other prior malignancy within the past 5 years except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * At least 2 weeks since prior systemic corticosteroids Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent antibiotics for active or resolving infection
References
Publications (1)
- RESULTLitzow MR, Lee S, Bennett JM, Dewald GW, Gallagher RE, Jain V, Paietta EM, Racevskis J, Rousey SR, Mazza JJ, Tallman MS. A phase II trial of arsenic trioxide for relapsed and refractory acute lymphoblastic leukemia. Haematologica. 2006 Aug;91(8):1105-8. Epub 2006 Jul 25. PMID 16870552