- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00003187
Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma
The Unrelated Donor Marrow Transplantation Trial
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Eliminating the T cells from the donor cells before transplanting them may prevent this from happening.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of conventional bone marrow transplantation with T cell-depleted bone marrow transplantation in treating patients who have leukemia, myelodysplasia, or lymphoblastic lymphoma.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
OBJECTIVES: I. Compare the disease free survival of patients with leukemia, myelodysplasia, or lymphoblastic lymphoma after treatment with conventional (non-T cell depleted) or T cell depleted unrelated donor bone marrow transplantation. II. Compare the incidence of primary and secondary graft failure, acute and chronic graft-vs-host disease, complications (infection, veno-occlusive disease, interstitial pneumonitis), and relapse in these patients after these treatments. III. Compare the incidence of other malignancies, lymphoproliferative disorders, and post-transplant myelodysplasia in these patients after these treatments.
OUTLINE: This is a randomized, multicenter study. Patients will be stratified according to institution. Patients are assigned to one of two treatment arms, one with conventional bone marrow transplantation (arm I) and one with T cell depletion of the bone marrow (arm II). Arm I: Patients receive cyclophosphamide on days -6 and -5. Total body irradiation (TBI) is administered on days -4 to 0, although this order may be reversed. Males with ALL receive a testicular boost of radiation therapy. Bone marrow is infused on day 0. Patients receive cyclosporine beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11. Arm II: T cell depletion is conducted by 2 different methods, according to the institution, and treatment varies depending on the method used. Method I is by T10B9 depletion and Method II is by counterflow elutriation depletion. Method I: Depending on the institution, some patients receive TBI on days -9 to -7 (before chemotherapy) (Course I) and some receive TBI on days -3 to -1 (after chemotherapy) (Course II). Course I also includes cytarabine IV on days -5 to -3, cyclophosphamide IV on days -2 and -1, and methylprednisolone IV on days -2 to 0 and 5-18. Bone marrow infusion is administered on day 0. Cyclosporine begins on day -1. Course II includes cytarabine IV on days -7 to -4 and cyclophosphamide on days -6 to -5. Methylprednisolone IV is administered on days -2 to 0 and 5-18. Bone marrow infusion is administered on day 0. Cyclosporine begins on day 0. Method II: Preparative therapy varies according to the disease category. Acute lymphoblastic leukemia: Patients undergo TBI on days -7 to -4. Males receive testicular boost on day -7, and all receive electron boost to anterior and posterior chest wall on days -5 and -4. Cyclophosphamide IV is administered on days -3 and -2. Bone marrow infusion is administered on day 0. Acute nonlymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome: Patients receive cyclophosphamide IV on days -7 and -6, followed by TBI on days -4 to -1. Bone marrow infusion is administered on day 0. Patients receive methylprednisolone IV every 12 hr on days -2,-1, and 5-19. Cyclosporine is administered from day -3 to day 180. All patients on both arms receive filgrastim (granulocyte colony-stimulating factor; G-CSF) beginning on day 7 post-transplant. Patients are followed weekly for the first 14 weeks, at day 100, every 6 months for 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study within 4 years.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Luoghi di studio
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California
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Stanford, California, Stati Uniti, 94305-5408
- Stanford University Medical Center
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55455
- University of Minnesota Medical School
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New York
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New York, New York, Stati Uniti, 10021
- Memorial Sloan-Kettering Cancer Center
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Stati Uniti, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Ohio
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Columbus, Ohio, Stati Uniti, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15224
- Western Pennsylvania Hospital
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South Carolina
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Columbia, South Carolina, Stati Uniti, 29203
- University of South Carolina School of Medicine
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Utah
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Salt Lake City, Utah, Stati Uniti, 84132
- Huntsman Cancer Institute
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Virginia
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Richmond, Virginia, Stati Uniti, 23298-0037
- Massey Cancer Center
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Midwest Children's Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS: Pathologically confirmed acute myeloid leukemia Not in first complete remission with translocations t(8;21) unless failed first line induction therapy Not in first complete remission with translocations t(15;17) or 16q abnormality unless: Failed first line induction therapy OR Molecular evidence of disease Pathologically confirmed acute lymphoblastic lymphoma (ALL) Not in first complete remission OR High risk ALL in first complete remission defined as: Hypodiploidy OR Pseudodiploidy with translocations t(9,22), t(4;11), or t(8;14) OR Elevated WBC at presentation Greater than 100,000/mm3 if 6-12 months old Greater than 50,000/mm3 if 10-20 years old Greater than 20,000/mm3 if 21 or over OR Failed to achieve complete remission after 4 weeks of induction therapy Pathologically confirmed chronic myelogenous leukemia (CML) not in blast crisis Pathologically confirmed undifferentiated leukemia or biphenotypic leukemia Pathologically confirmed juvenile CML with or without either 7q- or infantile monosomy 7 Leukocytosis with absolute monocytosis greater than 450 microliters AND Immature myeloid cells in peripheral blood circulation Less than 25% marrow blasts Myelodysplastic syndromes: Refractory anemia (RA) RA with ringed sideroblasts RA with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia Pathologically confirmed stage IV lymphoblastic lymphoma No active CNS or skin leukemic involvement No consenting suitably HLA-matched related donor available Consenting unrelated donor available
PATIENT CHARACTERISTICS: Age: 55 and under Performance status: Karnofsky 70-100% OR Lansky 60-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.5 mg/dL SGOT less than 3 times upper limit of normal Renal: Creatinine within normal range OR Creatinine clearance greater than 60 mL/min Cardiovascular: Asymptomatic OR Left ventricular ejection fraction at rest greater than 40% and improves with exercise Pulmonary: Asymptomatic OR DLCO greater than 45% Other: Not pregnant or lactating HIV negative No uncontrolled viral, bacterial, or fungal infection
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior autologous or allogeneic bone marrow transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No concurrent mediastinal radiation No prior radiation therapy that would preclude total body irradiation Surgery: Not specified
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Lee Ann Jensen, PhD, National Heart, Lung, and Blood Institute (NHLBI)
Pubblicazioni e link utili
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
- anemia refrattaria
- anemia refrattaria con sideroblasti ad anello
- anemia refrattaria con blasti in eccesso
- anemia refrattaria con eccesso di blasti in trasformazione
- leucemia mielomonocitica cronica
- sindromi mielodisplastiche de novo
- sindromi mielodisplastiche precedentemente trattate
- sindromi mielodisplastiche secondarie
- leucemia linfoblastica acuta infantile in remissione
- leucemia mieloide acuta infantile in remissione
- leucemia mieloide cronica in fase cronica
- sindromi mielodisplastiche infantili
- leucemia mieloide acuta ricorrente dell'adulto
- leucemia mieloide acuta dell'adulto non trattata
- leucemia linfoblastica acuta infantile non trattata
- leucemia mieloide acuta dell'adulto in remissione
- leucemia mieloide cronica recidivante
- Linfoma linfoblastico adulto stadio IV
- leucemia linfoblastica acuta ricorrente dell'adulto
- leucemia linfoblastica acuta infantile ricorrente
- Linfoma linfoblastico infantile in stadio IV
- leucemia mieloide cronica in fase accelerata
- leucemia linfoblastica acuta dell'adulto in remissione
- leucemia mieloide acuta infantile ricorrente
- leucemia acuta indifferenziata
- leucemia linfoblastica acuta dell'adulto non trattata
- leucemia mieloide acuta infantile non trattata e altre neoplasie mieloidi
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Patologia
- Malattie del midollo osseo
- Malattie ematologiche
- Condizioni precancerose
- Leucemia, linfoide
- Linfoma
- Sindrome
- Sindromi mielodisplastiche
- Leucemia
- Preleucemia
- Leucemia-linfoma linfoblastico a cellule precursori
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti antivirali
- Inibitori della sintesi degli acidi nucleici
- Inibitori enzimatici
- Agenti antinfiammatori
- Agenti antireumatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Antiemetici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti neuroprotettivi
- Agenti protettivi
- 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
- Metilprednisolone
- Ciclofosfamide
- Citarabina
- Metotrexato
- Ciclosporina
- Ciclosporine
Altri numeri di identificazione dello studio
- CDR0000066016
- P30CA016059 (Sovvenzione/contratto NIH degli Stati Uniti)
- MCV-CCHR-9504-2X
- DUMC-75951
- NCI-G98-1388
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 .