Clinical trial · Interventional
Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes
Phase II Trial of Gleevec and Low-Dose Ara-C for Elderly Patients With C-Kit Positive Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
NCT00451997CI-TRIAL-00007699completedPhase 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)
The goal of this clinical research study is to learn if the combination of Gleevec (imatinib mesylate) and low doses of Cytarabine (ara-C) may help to control leukemia while causing fewer side effects than standard high dose chemotherapy.
Conditions
Conditions (2)
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, Myeloid | Myeloid Leukemia | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-C | Drug | Cytarabine | ALIAS |
| Gleevec | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gleevec + Low-Dose Ara-C
- interventionNames
- Drug: Gleevec
- Drug: Ara-C
Primary outcomes (1)
- measure
- Efficacy of a combination of imatinib and low dose ara-C in elderly or high-risk patients with AML and MDS, as measured by the rate of early mortality or progression.
- timeFrame
- April 2007
Secondary outcomes (7)
- measure
- Rate of overall response, including CRp and PR.
- timeFrame
- April 2007
- measure
- To determine the safety profile of this combination.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are not candidates for intensive chemotherapy with any of the following diagnosis: 1. AML or MDS (with \>/=5% blasts) age \>/= 65 years old (or age \>/= 60 if high-risk cytogenetics), or 2. AML or MDS (RAEB or RAEBT) of any cytogenetic group age 60 or older with minimally treated disease who have relapsed disease or are refractory to therapy and not likely to require cytoreductive therapy within one month, and, or 3. CMML. * Patients with WHO performance status of 0 to 2 * Patients must have recovered from prior cytotoxic chemotherapy; treatment with hydrea is allowed up to 24 hours prior to day 1 of study drug administration * Written informed consent obtained according to local guidelines * Patients must have a serum creatinine of \</= 1.5 x ULN, SGPT \</= 3 x ULN and total bilirubin \</= 2.0 x ULN. * Patients with \>/= 20% blasts positive for c-kit (CD117) (except for CMML) * Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of childbearing potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug. Exclusion Criteria: * Patients with uncontrolled active infection * Patients with NYHA class III or IV * Women who are pregnant * Women who are breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.