- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00244829
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
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with high-risk Philadelphia chromosome-positive leukemia.
Secondary
- Determine the bcr/abl transcript load during the first 90 days after AHSCT in patients treated with this drug from the time of engraftment.
- Determine the 1-year survival of patients treated with this drug.
OUTLINE: This is an open-label, pilot, multicenter study.
Beginning within 14-30 days after allogeneic stem cell transplantation, patients receive oral imatinib mesylate once daily until 1 year after transplantation. Treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Undersøgelsestype
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Safety at 90 days following transplant
|
Sekundære resultatmål
Resultatmål |
---|
Overlevelse ved 1 år
|
BCR/ABL transcript load at 90 days following transplant
|
Standard management of progressive minimal residual disease at 90 days following transplant
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Paul Carpenter, MD, Fred Hutchinson Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
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
Nøgleord
- akut lymfatisk leukæmi i barndommen i remission
- kronisk fase kronisk myelogen leukæmi
- kronisk myelogen leukæmi i barndommen
- blastisk fase kronisk myelogen leukæmi
- Philadelphia kromosom positiv kronisk myelogen leukæmi
- accelereret fase kronisk myelogen leukæmi
- akut lymfatisk leukæmi hos voksne i remission
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1867.00
- FHCRC-1867.00
- CDR0000355118 (Registry Identifier: PDQ)
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