- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00245128
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
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Determine the safety, efficacy, and tolerability of imatinib mesylate in patients with myelofibrosis with myeloid metaplasia.
- Determine the 3-, 6-, and 12-month major and minor erythroid response rates in patients treated with this drug.
Secondary
- Determine reduction in marrow fibrosis in patients treated with this drug.
- Determine decrease in spleen size in patients treated with this drug.
OUTLINE: This is a multicenter, open-label, nonrandomized, pilot study.
Patients receive oral imatinib mesylate once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients who do not experience a minor erythroid response or a 50% reduction in spleen size after 6 months of treatment are removed from the study. Patients experiencing clinical benefit (e.g., ongoing erythroid response) after 1 year of treatment may continue treatment with imatinib mesylate as above at the discretion of the principal investigator.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97239-3098
- OHSU Knight Cancer Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy
Tidsramme: At 3,6, and 12 months of therapy
|
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. |
At 3,6, and 12 months of therapy
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Reduction in Marrow Fibrosis and Decrease in Spleen Size
Tidsramme: After 6 and 12 months of therapy
|
After 6 and 12 months of therapy
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000445435
- OHSU-541 (Anden identifikator: OHSU IRB)
- OHSU-HEM-01071-L (Anden identifikator: OHSU Knight Cancer Institute)
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