Clinical trial · Interventional
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation
Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase in Relapse After Allogeneic Stem Cell Transplantation
NCT00219726CI-TRIAL-00007905completedPhase 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 aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.
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 |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- - to assess the tolerability of Imatinib given at a daily dose of 400mg
- measure
- - to evaluate the hematologic, cytogenetic and molecular responses at various check points.
Secondary outcomes (2)
- measure
- - to assess donor/recipient chimerism during Imatinib therapy
- measure
- - to evaluate the survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CML Ph+ (assessed by cytogenetic or FISH) * Age ≥ 18 year at inclusion * PS grade 0 to 2 (ECOG) * previous allogeneic stem cell transplantation * molecular, cytogenetic or haematological relapse in chronic phase after transplantation * Immune therapy for graft versus host disease stopped within 2 months from inclusion * Adequate and organ function, defined as the following: total bilirubin \<3x uln, sgpt \<3x uln, creatinine \<2x uln. * informed consent sign up Exclusion Criteria: * Age less than 18 y * accelerated or blastic phase * previous therapy with imatinib * active malignancy other than CML or non-melanoma cancer of the skin * current treatment with another investigational agent
References
Publications (0)
Data not yet available
No reference posted for this study.