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Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer

12 maggio 2010 aggiornato da: Fred Hutchinson Cancer Center

Conditioning For Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and 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 abnormal or 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 antithymocyte globulin, tacrolimus, and methotrexate before or after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan followed by donor peripheral stem cell transplant and antithymocyte globulin, tacrolimus, and methotrexate works in treating patients with myeloid cancer.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

Determine the incidence and severity of acute graft-versus-host disease (GVHD) in patients with myeloid malignancies treated with conditioning regimen comprising fludarabine phosphate and busulfan followed by allogeneic peripheral blood stem cell transplantation and GVHD prophylaxis comprising antithymocyte globulin, tacrolimus, and methotrexate.
Determine the incidence of donor engraftment in patients treated with this regimen.

Secondary

Determine the pharmacokinetics of IV busulfan, including interdose variability and evaluation of a limited sampling strategy, in these patients.
Determine the pharmacokinetics of antithymocyte globulin in these patients.
Determine the pharmacokinetics of fludarabine phosphate and its effect on lymphocytes in these patients.
Determine the incidence of specific toxic effects ≥ grade 3 in patients treated with this regimen.
Determine the incidence and severity of chronic GVHD in these patients.
Determine the incidence of nonrelapsing mortality at 100 days and at 1 year after transplantation in these patients.
Determine the incidence of relapse in these patients.
Determine relapse-free survival of these patients.
Determine the incidence of Epstein-Barr virus activation in these patients.

OUTLINE:

Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and busulfan IV over 3 hours on days -5 to -2. Prior to the conditioning regimen, patients whose cerebrospinal fluid is positive for malignant cells receive intrathecal methotrexate or cranial irradiation for CNS prophylaxis.
Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients receive filgrastim (G-CSF)-mobilized allogeneic PBSCs IV on day 0.
Graft-versus-host disease prophylaxis: Patients receive antithymocyte globulin IV over at least 10 hours on days -3 to -1. They also receive tacrolimus orally twice daily or IV continuously beginning on day -1 and continuing until up to day 55, followed by a taper until day 180 in the absence of graft-versus-host disease. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

After completion of study treatment, patients are followed annually.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Stati Uniti
- Washington
  - Seattle, Washington, Stati Uniti, 98109-1024
    - Fred Hutchinson Cancer Research Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 65 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following myeloid malignancies:
- Chronic myelogenous leukemia meeting 1 of the following criteria:
  - Chronic phase
  - Accelerated phase
  - Treated blast phase
- Acute myeloid leukemia meeting 1 of the following criteria:
  - In remission
  - In early relapse, defined as < 10% marrow blasts
- Myelodysplastic syndromes, including all risk groups
- Other myeloproliferative disorders
HLA-A, -B, -C, -DRB1, and -DQB1 matched related or unrelated donor available

PATIENT CHARACTERISTICS:

No other disease that would severely limit life expectancy
AST ≤ 2 times normal
Creatinine ≤ 2 times normal OR creatinine clearance ≥ 60 mL/min
No cardiac insufficiency requiring treatment
No symptomatic coronary artery disease
PO_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR PO _2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted
HIV negative
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

No post-transplantation growth factor during methotrexate administration

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Incidence and severity of acute graft-versus-host disease (GVHD)
Incidence of donor engraftment

Misure di risultato secondarie

Misura del risultato
Sopravvivenza libera da ricadute
Incidenza di recidiva
Pharmacokinetics of IV busulfan including interdose variability and evaluation of a limited sampling strategy
Pharmacokinetics of antithymocyte globulin
Pharmacokinetics of fludarabine phosphate and its effect on lymphocytes
Incidence of specific toxic effects ≥ grade 3
Incidence and severity of chronic GVHD
Incidence of nonrelapsing mortality at 100 days and at 1 year after transplantation
Incidence of Epstein-Barr virus activation and post-transplantation lymphoproliferative disease

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fred Hutchinson Cancer Center

Collaboratori

National Cancer Institute (NCI)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2006

Completamento dello studio (Effettivo)

1 novembre 2007

Date di iscrizione allo studio

Primo inviato

28 giugno 2006

Primo inviato che soddisfa i criteri di controllo qualità