Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Myelofibrosis
A Phase II Pilot Study to Determine the Safety and Preliminary Efficacy of Imatinib Mesylate (Gleevec) in Patients With Myelofibrosis With Myeloid Metaplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Per PI, results from another similar study were published prior to study analysis. Negative study results were published therefore analysis was not completed
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. PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well it works in treating patients with myelofibrosis.
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 Myeloproliferative Disorders | Myeloproliferative Neoplasm | 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 (1)
- measure
- Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy
- timeFrame
- At 3,6, and 12 months of therapy
- description
- A major response = transfusion independent or a\>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks. Minor response= \> 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period.
Secondary outcomes (1)
- measure
- Reduction in Marrow Fibrosis and Decrease in Spleen Size
- timeFrame
- After 6 and 12 months of therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of myelofibrosis with myeloid metaplasia (MMM), defined by all of the following: * Leukoerythroblastic blood picture * Fibrosis involving \> 1/3 sectional area of bone marrow biopsy * Splenomegaly (unless patient has undergone prior splenectomy) * Philadelphia chromosome negative * No myelodysplastic syndrome * No systemic disorders associated with marrow fibrosis * Red blood cell transfusion dependent, defined by 1 of the following: * Patient has required ≥ 2 units of red blood cells every 4 weeks within the past 8 weeks * Hemoglobin ≤ 8 g/dL on ≥ 3 occasions (≥ 2 weeks apart ) over the past 8 weeks * No evidence of disease transformation to acute myelogenous leukemia, defined as \> 20% blasts in bone marrow and/or peripheral blood PATIENT CHARACTERISTICS: Performance status * ECOG 0-3 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 50,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST or ALT ≤ 2 times ULN (unless due to extramedullary hematopoiesis in the liver) Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No New York Heart Association grade III-IV heart disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment * No serious, uncontrolled medical condition * No patients who are considered potentially unreliable or with a history of noncompliance to medical regimens PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior interferon alfa Chemotherapy * No concurrent chemotherapy except hydroxyurea to control elevated blood counts Endocrine therapy * More than 4 weeks since prior corticosteroids, danazol, or other androgens for MMM Other * More than 4 weeks since other prior treatment for MMM * No other concurrent experimental drug therapy for MMM
References
Publications (0)
Data not yet available