Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
OBJECTIVES:
- Determine the non-relapse toxicity and mortality on day 100 and at 1 year after transplantation in patients with low or intermediate-risk myelodysplastic syndrome treated with busulfan, cyclophosphamide, and allogeneic peripheral blood stem cell transplantation.
- Determine the incidence of donor stem cell engraftment and relapse-free survival in these patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease and invasive fungal infections in these patients treated with this regimen.
- Determine the incidence of relapse in these patients treated with this regimen.
OUTLINE: Peripheral blood stem cells (PBSC) or bone marrow are harvested from a related or unrelated compatible donor. PBSC are selected for CD34+ cells.
Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Allogeneic PBSC or bone marrow is infused on day 0.
As graft-versus-host disease prophylaxis, patients receive cyclosporine IV beginning on day -1 and continuing orally twice daily (if feasible) until day 51 followed by a taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Patients are followed through day 100, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
Type d'étude
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
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Washington
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Seattle, Washington, États-Unis, 98109
- Fred Hutchinson Cancer Research Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Diagnosis of low or intermediate-risk myelodysplastic syndrome
- Refractory anemia (RA)
- RA with ringed sideroblasts
- No advanced myelodysplastic syndrome (i.e., at least 5% blasts in the marrow, more than 1% blasts in the peripheral blood, or blasts in the cerebrospinal fluid)
- No poor-risk cytogenetics (i.e., abnormalities of chromosome 7 or complex abnormalities)
HLA-A, B, C, DRB1, and DQB1 compatible related or unrelated donor available
- Mismatch for a single HLA-A, B, C, DRB1, or DQB1 allele allowed
PATIENT CHARACTERISTICS:
Age:
- 65 and under
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- AST no greater than 2 times normal
Renal:
- Creatinine no greater than 2 times upper limit of normal
- Creatinine clearance at least 50%
Cardiovascular:
- No cardiac insufficiency requiring treatment
- No symptomatic coronary artery disease
Pulmonary:
- No severe hypoxemia (pO2 less than 70 mm Hg with DLCO less than 70% predicted)
- No mild hypoxemia (pO2 less than 80 mm Hg with DLCO less than 60% predicted)
Other:
- No other disease that would limit life expectancy
- HIV negative
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: H. Joachim Deeg, MD, Fred Hutchinson Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Tumeurs
- Maladie
- Maladies de la moelle osseuse
- Maladies hématologiques
- Conditions précancéreuses
- Syndrome
- Syndromes myélodysplasiques
- Préleucémie
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Inhibiteurs de la synthèse des acides nucléiques
- Inhibiteurs d'enzymes
- Agents antirhumatismaux
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agonistes myéloablatifs
- Agents dermatologiques
- Agents antifongiques
- Agents de contrôle de la reproduction
- Agents abortifs, non stéroïdiens
- Agents abortifs
- Antagonistes de l'acide folique
- Inhibiteurs de la calcineurine
- Cyclophosphamide
- Méthotrexate
- Busulfan
- Ciclosporine
- Cyclosporines
Autres numéros d'identification d'étude
- 1536.00
- FHCRC-1536.00
- NCI-G01-2009
- CDR0000068887 (Identificateur de registre: PDQ)
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