Clinical trial · Interventional
STI571 in Treating Patients With Recurrent Leukemia
A Phase I Study of STI571 in Ph+ Leukemia
NCT00004932CI-TRIAL-00013826completedPhase 1ClinicalTrials.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: Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia. PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent 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 |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 260 mg/m2 imatinib mesylate (ST571)
- interventionNames
- Drug: imatinib mesylate
- type
- EXPERIMENTAL
- label
- 340 mg/m2 imatinib mesylate (ST571)
- interventionNames
- Drug: imatinib mesylate
- type
- EXPERIMENTAL
- label
- 440 mg/m2 imatinib mesylate (ST571)
- interventionNames
- Drug: imatinib mesylate
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Recurrent Philadelphia (Ph) chromosome-positive leukemia
* Recurrent or refractory acute lymphoblastic or myeloblastic leukemia OR
* Chronic myelogenous leukemia with resistance to interferon alfa with any of the following:
* WBC at least 20,000/mm\^3 after at least 3 months of interferon therapy
* At least 100% increase in WBC to at least 20,000/mm\^3 confirmed over 2 weeks while receiving interferon alfa
* At least 66% Ph chromosome-positive cells after 1 year of interferon therapy
* At least 30% increase in number of Ph chromosome-positive cells after an interferon-induced response while continuing interferon therapy
PATIENT CHARACTERISTICS:
Age:
* Under 22
Performance status:
* Karnofsky 50-100% if over 10 years of age OR
* Lansky 50-100% if 10 years of age and under
Life expectancy:
* At least 8 weeks
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGPT less than 3 times normal
* Albumin greater than 2 g/dL
Renal:
* Creatinine no greater than 1.5 times normal OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* If prior allogeneic stem cell transplantation, no uncontrolled graft-versus -host disease
* No seizure disorder if on anticonvulsants
* No uncontrolled infection
* No CNS toxicity greater than grade 2
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* At least 1 week since prior biologic therapy and recovered
* At least 3 months since prior stem cell transplantation (SCT)
* At least 1 week since prior growth factors
* At least 1 week since prior interferon alfa
Chemotherapy:
* Recovered from prior chemotherapy
* At least 6 weeks since prior busulfan and nitrosoureas
* At least 2 weeks since prior homoharringtonine
* At least 1 week since low-dose cytarabine
* At least 2 weeks since prior moderate-dose cytarabine
* At least 4 weeks since prior high-dose cytarabine
* At least 3 weeks since all other prior cytotoxic chemotherapies
* No prior hydroxyurea
Endocrine therapy:
* Must be on a stable dose of steroids if received prior allogeneic SCT
Radiotherapy:
* Recovered from prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior craniospinal radiotherapy
* At least 6 months since prior radiotherapy to 50% or more of the pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
Surgery:
* Not specified
Other:
* No other concurrent investigational agents
* No concurrent anticonvulsantsReferences
Publications (2)
- RESULTChampagne MA, Capdeville R, Krailo M, Qu W, Peng B, Rosamilia M, Therrien M, Zoellner U, Blaney SM, Bernstein M; Children's Oncology Group phase 1 study. Imatinib mesylate (STI571) for treatment of children with Philadelphia chromosome-positive leukemia: results from a Children's Oncology Group phase 1 study. Blood. 2004 Nov 1;104(9):2655-60. doi: 10.1182/blood-2003-09-3032. Epub 2004 Jul 1. PMID 15231574
- RESULTChampagne MA, Hershon L, Rosamilia M, et al.: STI571 in the Treatment of Pediatric Philadelphia (Ph+) Chromosome-Positive Leukemia: A Children's Oncology Group Phase 1 Study (P-9973). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1466, 2001.