N/A
N=125
Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate
Chronic Myelomonocytic Leukemia · Chronic Myeloid Leukemia · Polycythemia Vera · Hypereosinophilic Syndrome · Mastocytosis
Bottom Line
View on ClinicalTrials.gov: NCT00038675 ↗Enrolled (actual)
125
Serious AEs
10.4%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants With a Complete Response (CR) — 0; 0; 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Imatinib Mesylate (Gleevec) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Complete Response (CR) |
0; 0; 2; 0; 3; 4 | — |
| SECONDARY Duration of Response |
68 | — |
| SECONDARY Overall Survival |
73.2 | — |
Summary
The goal of this clinical research study is to see if Gleevec, known as imatinib mesylate (STI571), can improve the disease condition in patients with hypereosinophilic syndrome, polycythemia vera, atypical CML or CMML with PDGF-R fusion genes, or mastocytosis.
Eligibility Criteria
Inclusion Criteria
- Participants must have 1 of the following hematopoietic malignancies: Hypereosinophilic syndrome (HES), Polycythemia vera (PV), Atypical CML or CMML with PDGF-R fusion genes, Mastocytosis, Serum bilirubin less than 2 mg%, serum creatinine less than 2 mg% unless abnormality is considered due to hematologic malignancy by investigator, Eastern Cooperative Oncology Group (ECOG) performance status 12 wks,
- continued from above. Participants must sign informed consent indicating they are aware of the investigational nature of the study, in keeping with policies of the hospital, women of pregnancy potential must practice birth control. Women and men must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug. Inclusion of women and minorities: As per NIH policy, women and members of minorities will be included as they are referred in the relevant populations.
- continued from above. There are no exclusions of women or minorities based on the study objectives, New York Heart Association (NYHA) Class <3.
Exclusion Criteria
N/A
Data sourced from ClinicalTrials.gov (NCT00038675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.