- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00027560
Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer
Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan, Fludarabine, And Anti-CD52 Monoclonal Antibody (CAMPATH-1H) Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphohematopoietic Malignancies
RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well fludarabine, melphalan, alemtuzumab, and peripheral stem cell transplant work in treating patients with hematologic cancer.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
OBJECTIVES:
Overall survival-12 months
Overall survival-24 months
Acute Graft-versus-Host Disease Matched Related patients-up to 4 months post transplant
Acute Graft-versus-Host Disease Unrelated and Mismatched related patients- up to 4 months post transplant
Chronic Graft-versus-Host Disease Matched Related patients- up to 2 years post transplant
Chronic Graft-versus-host disease Unrelated and Mismatched related patients- up to 2 years post transplant
- OUTLINE: Patients are stratified according to donor type (HLA-matched related vs HLA-matched unrelated, single HLA-allele disparate related, or unmatched) (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06).
Patients receive a nonmyeloablative regimen comprising alemtuzumab IV over 8 hours on days -8 to -5, fludarabine IV over 30 minutes on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Allogeneic peripheral blood stem cells or bone marrow is infused on day 0.
Patients receive graft-versus host disease prophylaxis comprising cyclosporine IV every 12 hours beginning on day -1 and continuing orally as tolerated until day 100.
Patients are followed every 6 weeks for 6 months, every 3 months for 6 months, every 3-6 months for 1 year, and then annually thereafter or as clinically indicated.
PROJECTED ACCRUAL: A maximum of 50 patients (25 HLA-matched related and 25 HLA-mismatched related or matched unrelated) will be accrued for this study within 2 years (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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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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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
INCLUSION CRITERIA:
- Disease criteria: This trial is primarily designed for: 1) patients with relapsed or primary refractory non-Hodgkin's lymphoma, 2) chemosensitive relapsed or refractory acute and chronic lymphocytic leukemias, 3) relapsed or primary refractory Hodgkin's Disease, or advanced (Durie-Salmon stage II or III) multiple myeloma, advanced Waldenstrom macroglobulinemia, who, by virtue of advanced age, intensity of prior radiation and/or chemotherapy, history of prior toxicity associated with chemo/radiotherapy or existing organ dysfunction, would be at undue risk of regimen associated mortality if transplanted according to protocols involving myeloablative conditioning regimens.
- Patients with aggressive NHL histologies must have chemo/radiosensitive disease, or have non-progressive disease, or have stable disease on therapy, and be ineligible for an autologous HSC transplant because of disease in the marrow.
- Patients with chronic myeloid leukemia and high risk forms of acute myelogenous leukemia or myelodysplastic syndromes are also eligible in the absence of an alternative active higher priority allogeneic transplant protocol for which they are eligible.
- Age criteria: Patients may be up to 70 years of age. There is no lower age threshold. Patients above the age of 70 may also participate, after evaluation and approval by the BMT Service attendings.
- Absence of active or uncontrolled bacterial, viral, or fungal infection that would contraindicate the use of myelosuppressive chemotherapy.
- Patients must have a healthy HLA-compatible donor, either a matched or single HLA allele disparate related donor or a similarly compatible unrelated donor recruited through the National Marrow Donor Program. Related donors must be willing to participate as research subjects and be willing to receive G-CSF to mobilize PBPC and undergo leukapheresis to donate PBSC. Unrelated donors identified by the NMDP may elect to donate either PBSC after treatment with G-CSF, or bone marrow. These unrelated donors will provide informed consent and their PBSC or bone marrow donations will be obtained at a qualified donor center participating in the NMDP.
- Each patient must be willing to participate as a research subject and must sign an informed consent form after discussion of the nature and risks of the study prior to entering the protocol. Parents or legal guardians of patients who are minors will sign the consent form for these patients after discussion of the nature and risks of the study.
EXCLUSION CRITERIA:
- Female patients who are pregnant or lactating.
- Active or uncontrolled viral (including HIV-1), bacterial or fungal infection.
- Severe renal insufficiency (creatinine >2.0 or creatinine clearance < 30mL/minute)
- Severe hepatic dysfunction, as defined by: total bilirubin greater than 2.5 mg/dL and AST and ALT >3xnl, unless the liver is involved with disease.
- Severe cardiac insufficiency, defined as a resting left ventricular ejection of less than 30% as measured by echocardiography or radionuclide cardiac angiography. Patients on cardiac medications for congestive heart failure are eligible, as long as their LVEF is greater than 30% on medication.
- Severe pulmonary insufficiency, as defined by an adjusted diffusing capacity of less than 40% of predicted value.
- Karnofsky or Lansky score <40%
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 |
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Sperimentale: TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
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Consenting individuals will receive pretransplant immunosuppressive cytoreduction, which will consist of 4 days of Campath-1H, 5 days of fludarabine, and two days of melphalan. All therapy should be completed approximately 24-36 hours before administration of the primary allograft. Campath-1H (20mg/dose/day) will be administered for each of four days from day -8 to day -5, inclusive. Each dose will be infused intravenously over 8 hours.
Altri nomi:
Patients will be treated with Cyclosporine as prophylaxis against GvHD.
Cyclosporine will be initiated at least 1 day prior to transplant at a dose of 1.5 mg / kg IV q12h (3 mg / kg / day = total daily dose).
Dose will thereafter be adjusted to maintain a trough serum level of 200-300 ng /ml.
Cyclosporine will be administered intravenously until the patient tolerates full alimentation, at which time conversion to oral dosing to sustain therapeutic levels will be initiated according to standard BMT service guidelines.
Fludarabine, 25mg/m2/d will be administered for each of five days from day -8 to day -4, inclusive.
Each dose will be infused intravenously over 30 minutes.
Melphalan will be administered intravenously over 30 minutes on each of two days from day -3 to day -2, inclusive.
The dose for recipients of HLA-matched related grafts will be 50 mg/m2/day x 2. The dose for recipients of HLA-matched unrelated and HLA-single allele disparate related or unrelated marrow or PBSC transplants will be 70 mg/m2/day x 2.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Overall Survival
Lasso di tempo: 12 months post transplant
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12 months post transplant
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Overall Survival
Lasso di tempo: 24 months post transplant
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24 months post transplant
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Acute Graft-versus-Host Disease Matched Related Patients
Lasso di tempo: up to 4 months post transplant
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Grade III-IV Acute Graft-versus-Host Disease
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up to 4 months post transplant
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients
Lasso di tempo: up to 4 months post transplant
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Grade III-IV Acute Graft-versus-Host Disease
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up to 4 months post transplant
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Extensive Chronic Graft-versus-Host Disease Matched Related Patients
Lasso di tempo: up to 2 years post transplant
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up to 2 years post transplant
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Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients
Lasso di tempo: up to 2 years post transplant
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up to 2 years post transplant
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Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Hugo R. Castro-Malaspina, MD, Memorial Sloan Kettering Cancer Center
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
- linfoma follicolare ricorrente di grado 3
- linfoma diffuso a grandi cellule dell'adulto ricorrente
- linfoma immunoblastico a grandi cellule dell'adulto ricorrente
- linfoma di Burkitt ricorrente dell'adulto
- linfoma a piccole cellule non clivate ricorrente nell'infanzia
- linfoma infantile ricorrente a grandi cellule
- sindromi mielodisplastiche precedentemente trattate
- leucemia mieloide acuta dell'adulto con anomalie 11q23 (MLL).
- leucemia mieloide cronica infantile
- sindromi mielodisplastiche infantili
- leucemia mieloide acuta ricorrente dell'adulto
- linfoma di Hodgkin ricorrente dell'adulto
- linfoma di Hodgkin infantile ricorrente/refrattario
- linfoma diffuso a piccole cellule recidivante dell'adulto
- linfoma diffuso a cellule miste ricorrente dell'adulto
- leucemia mieloide cronica recidivante
- Mieloma multiplo stadio II
- mieloma multiplo stadio III
- linfoma follicolare ricorrente di grado 1
- linfoma follicolare ricorrente di grado 2
- linfoma ricorrente della zona marginale
- piccolo linfoma linfocitico ricorrente
- linfoma a cellule B della zona marginale extranodale del tessuto linfoide associato alla mucosa
- linfoma a cellule B della zona marginale nodale
- linfoma splenico della zona marginale
- linfoma linfoblastico ricorrente dell'adulto
- linfoma mantellare ricorrente
- leucemia linfatica cronica refrattaria
- mieloma multiplo refrattario
- leucemia linfoblastica acuta ricorrente dell'adulto
- Macroglobulinemia di Waldenstrom
- leucemia linfoblastica acuta infantile ricorrente
- leucemia mieloide acuta infantile ricorrente
- neoplasia mielodisplastica/mieloproliferativa, non classificabile
- linfoma linfoblastico infantile ricorrente
- leucemia mieloide cronica atipica, BCR-ABL1 negativo
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Patologia
- Malattie del midollo osseo
- Malattie ematologiche
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Condizioni precancerose
- Neoplasie
- Linfoma
- Sindrome
- Sindromi mielodisplastiche
- Mieloma multiplo
- Neoplasie, plasmacellule
- Leucemia
- Preleucemia
- Plasmocitoma
- Malattie mieloproliferative
- Malattie mielodisplastiche-mieloproliferative
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Inibitori enzimatici
- Agenti antireumatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Agonisti mieloablativi
- Agenti antineoplastici, immunologici
- Agenti dermatologici
- Agenti antimicotici
- Inibitori della calcineurina
- Melfalan
- Fludarabina
- Fludarabina fosfato
- Ciclosporina
- Ciclosporine
- Alemtuzumab
Altri numeri di identificazione dello studio
- 01-092
- MSKCC-01092
- NCI-G01-2028
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 .
Prove cliniche su trapianto allogenico di midollo osseo
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