Clinical trial · Interventional
Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)
Open-label Multicenter Trial of Glivec® (Imatinib Mesylate, Formerly Known as STI571) in Combination With Chemotherapy (MTC) in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)
NCT00744081CI-TRIAL-00064612completedPhase 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 purpose of this study is to show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.
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 |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AraC | Drug | — | UNRESOLVED |
| Glivec | Drug | — | UNRESOLVED |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Refractory AML after primary therapy * First relapse after a safe previous diagnosis of de novo or secondary AML * Age \> 18 years * Serum bilirubin \< 2.0 mg/dl * Serum creatinine \< 1.5 times the normal value or a creatinine clearance \> 60 ml/min * ECG and heart echography prior to start of therapy without severe findings * Overall condition \< 2 according to ECOG criteria * Life expectancy \> 6 weeks * Written informed consent by patients with full legal capacity Exclusion Criteria: * Serious secondary disease (clinically relevant cardiac disease, chronic- obstructive pulmonary disease, hepatic dysfunction, renal insufficiency) * Active secondary neoplasia (exception: adequately treated basalioma or epidermoid cancer and cervical carcinoma) * Known hypersensitivity to topoisomerase-I inhibitors * Overall condition \> 2 according to ECOG criteria * Pregnant/breast feeding women * Serious intercurrent infections
References
Publications (0)
Data not yet available
No reference posted for this study.