Clinical trial · Interventional
Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia
A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias
- 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 stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant may prevent the recurrence of Philadelphia chromosome-positive leukemia. PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety at 90 days following transplant
Secondary outcomes (3)
- measure
- BCR/ABL transcript load at 90 days following transplant
- measure
- Standard management of progressive minimal residual disease at 90 days following transplant
- measure
- Survival at 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Acute lymphoblastic leukemia or chronic myeloid leukemia (CML) characterized by p\^190 and/or p\^210 bcr/abl gene rearrangement * Accelerated or blastic phase CML * CML in second or greater chronic phase * No imatinib mesylate-resistant leukemia * Planned allogeneic hematopoietic stem cell transplantation * Availability of an appropriately matched related or unrelated donor * Autologous or nonmyeloablative transplantation is not allowed * None of the following within 4 days after the date of neutrophil engraftment\*: * More than 5% marrow blasts * Circulating peripheral blood leukemic blasts * Aberrant antigen expression on marrow myeloblasts ≥ 1% by multidimensional flow cytometric assay * Presence of bcr/abl in \> 5% of marrow interphase nuclei by fluorescent in situ hybridization * More than 1 of 20 Philadelphia chromosome-positive marrow metaphases * CNS involvement by leukemia NOTE: \*The date of neutrophil engraftment is defined as the second consecutive day at which the peripheral blood absolute neutrophil count exceeds 500/mm3 PATIENT CHARACTERISTICS: Performance status * Not specified Life expectancy * At least 2 months Hematopoietic * See Disease Characteristics * Absolute neutrophil count ≥ 1,200/mm\^3 (use of filgrastim \[G-CSF\] allowed) Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known imatinib mesylate hypersensitivity * No other disease that severely limits life expectancy PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics
References
Publications (0)
Data not yet available