- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01020734
Donor Stem Cell Transplant or Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Myelogenous Leukemia in Remission Using HLA-Matched Sibling Donors, HLA-Matched Unrelated Donors, or HLA-Mismatched Familial Donors - A Phase 2 Study
RATIONALE: Giving chemotherapy before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and methotrexate before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor stem cell transplant or bone marrow transplant works in treating patients with acute myeloid leukemia in remission.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
OBJECTIVES:
Primary
- Evaluate the efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) or bone marrow transplantation (BMT) from a HLA-matched sibling donor, HLA-matched unrelated donor, or HLA-mismatched familial donor, in terms of the frequency of relapse and duration of remission, in patients with acute myeloid leukemia (AML) who have either achieved complete remission (CR1) after induction chemotherapy or who experienced recurrent AML then achieved second CR (CR2) after salvage chemotherapy.
Secondary
- Determine the engraftment, donor chimerism, and secondary graft failure in these patients.
- Assess acute and chronic graft-vs-host disease, immune recovery, and infections in these patients.
- Determine transplantation-related mortality, leukemia-free survival, and overall survival of these patients.
OUTLINE:
Conditioning chemotherapy and allogeneic bone marrow or hematopoietic stem cell transplantation (HSCT): After completion of induction chemotherapy and a resulting complete response (CR1) or salvage chemotherapy resulting in CR2, patients receive 1 of the following conditioning regimens and transplantations determined by age, co-morbidity, and type of available donor:
- 15 to 55 years of age without significant co-morbidity* undergoing HLA-matched sibling bone marrow transplantation (BMT) (BuCy conditioning): Patients receive busulfan IV once daily on days -7 to -4 and cyclophosphamide IV over 1-2 hours once daily on days -3 and -2. Patients then undergo an allogeneic BMT on day 0.
- Older than 55 years or younger than 55 years with co-morbidity* undergoing HLA-matched sibling BMT; patients of any age undergoing HLA-matched unrelated HSCT; and for patients of any age undergoing HLA-mismatched familial donor HSCT (BuFluATG conditioning): Patients receive busulfan IV once daily on days -7 and -6, fludarabine phosphate IV over 30 minutes once daily on days -7 to -2, anti-thymocyte globulin IV over 4 hours once daily on days -3 to -1, and methylprednisolone IV over 30 minutes once daily on days -4 to -1. Patients then undergo either an allogeneic BMT on day 0 or allogeneic peripheral blood hematopoietic stem cell infusions on days 0-1 or 0-2.
NOTE: *Significant co-morbidity is defined as residual fungal or other infections in the lung or other viscera and residual organ toxicities occurring during induction or consolidation chemotherapy.
- GVHD prophylaxis: Patients receive cyclosporine orally or IV over 2-4 hours twice daily beginning on day -1 followed by a taper starting on day 30 (BuFluATG conditioning) or day 60 (BuCy conditioning). Patients also receive methotrexate IV on days 1, 3, and 6 after the last day of donor cell infusion.
- CNS prophylaxis: Patients receive intrathecal (IT) methotrexate once before conditioning regimen. Patients receive IT methotrexate once every 2 weeks for 3 times after transplantation and platelet recovery. Patients also receive leucovorin calcium orally or IV over 4 hours after IT methotrexate and then once every 6 hours for a total of 8 doses after each dose of IT methotrexate.
After completion of study therapy, patients are followed every 3 months for 3 years and then annually.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Busan, Corea, Repubblica di, 612-030
- Inje University - Haeundae Paik Hospital
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Seoul, Corea, Repubblica di, 138-736
- Asan Medical Center - University of Ulsan College of Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
- Achieved complete response (CR1) after induction chemotherapy
- Recurrent AML that went into second CR (CR2) after salvage chemotherapy, except those who have undergone prior allogeneic HSCT
- No acute promyelocytic leukemia or acute myeloid leukemia with chromosomal changes t(8;21), inv 16, or t(15;17)
Must have a donor available meeting one of the following criteria:
- HLA-matched sibling of 65 years or younger
- 6/6 HLA-matched unrelated donor (younger than 55 years) for antigen A, B, and DR
- HLA-mismatched family member (offspring, parents, haploidentical sibling)
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Bilirubin < 2.0 mg/dL
- AST < 3 times the upper limit of normal
- Creatinine < 2.0 mg/dL
- Ejection fraction > 40% on MUGA scan
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: transplantation
perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Efficacy of the treatment measured in terms of frequency of relapse and duration of remission
Lasso di tempo: up to 2 years after transplantation
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duration of CR, leukemia recurrence
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up to 2 years after transplantation
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Engraftment
Lasso di tempo: up to 35 days after transplantation
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achievement of neutrophil count over 500/ul
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up to 35 days after transplantation
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Acute and chronic graft-versus-host disease
Lasso di tempo: up to 100 days for acute GVHD and up to 2 years for chronic GVHD
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up to 100 days for acute GVHD and up to 2 years for chronic GVHD
|
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Treatment-related mortality
Lasso di tempo: up to 2 years after transplantation
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up to 2 years after transplantation
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Leukemia-free survival and overall survival
Lasso di tempo: up to 2 years after transplantation
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up to 2 years after transplantation
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- leucemia mieloide acuta dell'adulto con anomalie 11q23 (MLL).
- leucemia mieloide acuta dell'adulto con t(16;16)(p13;q22)
- leucemia mieloide acuta infantile in remissione
- leucemia mieloide acuta ricorrente dell'adulto
- leucemia mieloide acuta dell'adulto in remissione
- leucemia megacarioblastica acuta dell'adulto (M7)
- leucemia mieloide acuta minimamente differenziata dell'adulto (M0)
- leucemia monoblastica acuta dell'adulto (M5a)
- leucemia monocitica acuta dell'adulto (M5b)
- leucemia mieloblastica acuta dell'adulto con maturazione (M2)
- leucemia mieloblastica acuta dell'adulto senza maturazione (M1)
- leucemia mielomonocitica acuta dell'adulto (M4)
- eritroleucemia dell'adulto (M6a)
- leucemia eritroide pura dell'adulto (M6b)
- leucemia mieloide acuta infantile ricorrente
- eritroleucemia acuta infantile (M6)
- leucemia megacariocitica acuta infantile (M7)
- leucemia mieloide acuta minimamente differenziata infantile (M0)
- leucemia mieloblastica acuta infantile senza maturazione (M1)
- leucemia mieloblastica acuta infantile con maturazione (M2)
- leucemia mielomonocitica acuta infantile (M4)
- leucemia monoblastica acuta infantile (M5a)
- leucemia monocitica acuta infantile (M5b)
- leucemia mieloide acuta dell'adulto con del(5q)
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Leucemia
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Inibitori della sintesi degli acidi nucleici
- Inibitori enzimatici
- Agenti antireumatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Agonisti mieloablativi
- Agenti dermatologici
- Agenti antimicotici
- Agenti di controllo riproduttivo
- Agenti abortivi, non steroidei
- Agenti abortivi
- Antagonisti dell'acido folico
- Inibitori della calcineurina
- Ciclofosfamide
- Fludarabina
- Fludarabina fosfato
- Metotrexato
- Busulfano
- Siero antilinfocitario
- Ciclosporina
- Ciclosporine
Altri numeri di identificazione dello studio
- CDR0000659891
- AMC-UUCM-2009-0579
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .