- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00740467
Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders
Allograft of Hematopoietic Stem Cells With Reduced-intensity Conditioning From a HLA-haploidentical Family Donor: Phase II Study of Combined Immunosuppression Before and After Transplantation
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together with antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. Giving chemotherapy before or after transplant also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer and abnormal 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 and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well stem cell transplant works in treating patients with hematological cancer or other disorders.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Evaluate the incidence of graft acceptance in patients with hematological disorders treated with combined immunosuppression before and after HLA-haploidentical hematopoietic stem cell transplantation.
Secondary
- Evaluate efficacy of this regimen in these patients.
- Evaluate toxicity of this regimen in these patients.
- Assess survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -6 to -1, busulfan IV on days -6 to -5, and anti-thymocyte globulin IV on days -4 to -1.
- Transplantation: Patients undergo transplantation of donor hematopoietic stem cells on day 0. Patients also receive cyclophosphamide IV on day 3 and filgrastim (G-CSF) beginning on day 4 and continuing until blood counts recover.
- Immunosuppression: Patients receive cyclosporine IV beginning on day -2 and continuing for 6 months and mycophenolate mofetil 4 times a day on days 4-84.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Marseille, Frankrig, 13273
- Rekruttering
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
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Kontakt:
- Contact Person
- Telefonnummer: 33-4-91-22-37-54
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Diagnosis of any of the following hematological cancers with a poor prognosis:
Acute myeloid leukemia meeting 1 of the following criteria:
- Third complete remission (CR3) or beyond
- CR2 after an early bone marrow relapse (< 24 months)
- Refractory disease after ≥ 2 chemotherapy courses of induction therapy
Acute lymphoblastic leukemia meeting 1 of the following criteria:
- CR3 after ≥ 1 bone marrow relapse
- CR2 after early bone marrow relapse (currently or within 6 months after stopping maintenance therapy)
Chronic myelogenous leukemia meeting the following criteria:
- Accelerated phase
- Second chronic phase
- No other treatment options
Multiple myeloma meeting the following criteria:
- Failed conventional therapy (including autologous hematopoietic stem cell transplantation)
- No other treatment alternatives
Chronic lymphocytic leukemia meeting the following criteria:
- Failed conventional therapy
- No other treatment alternatives
Hodgkin lymphoma meeting the following criteria:
- Failed conventional therapy
- No other treatment alternatives
Non-Hodgkin lymphoma meeting the following criteria:
- Failed conventional therapy
- No other treatment alternatives
- Not eligible for standard myeloablative allograft due to increased toxicity
Healthy related donor available and meeting the following criteria:
- Brother, sister, father, mother, cousin, uncle, or aunt
At least an identical HLA haplotype
- Identical genotype on 1 haplotype (in terms of HLA-A, B, C, and DR)
- Different on ≤ 4 alleles on the other haplotype
- No HLA-identical intra- or extra-familial donor cord blood available within the next 3 months
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Not pregnant or nursing
- Fertile patients must use effective contraception
No contraindication to allogeneic transplantation, including any of the following:
- Cardiac systolic ejection fraction < 40%
- DLCO level limiting use of fludarabine
- Creatinine clearance < 30 mL/min
- Transaminases and/or bilirubin > 3 times upper limit of normal (unless due to Gilbert disease or cancer)
- HIV seropositivity
- Human T-cell lymphotrophic virus type 1 seropositivity
- Uncontrolled bacterial, viral, or fungal infection
- No contraindication to any of the study drugs
- No prior or concurrent psychiatric illness
- No other cancer in the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix
- No concurrent serious, uncontrolled condition
- No patients deprived of liberty or subject to legal protection
PRIOR CONCURRENT THERAPY:
- No participation in a study of allografts in the past month
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Incidence of graft acceptance
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Didier Blaise, MD, Institut Paoli-Calmettes
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- tilbagevendende grad 3 follikulært lymfom
- tilbagevendende voksent diffust storcellet lymfom
- tilbagevendende voksen immunoblastisk storcellet lymfom
- recidiverende voksen Burkitt lymfom
- akut myeloid leukæmi hos voksne med 11q23 (MLL) abnormiteter
- akut myeloid leukæmi hos voksne med inv(16)(p13;q22)
- akut myeloid leukæmi hos voksne med t(15;17)(q22;q12)
- akut myeloid leukæmi hos voksne med t(16;16)(p13;q22)
- akut myeloid leukæmi hos voksne med t(8;21)(q22;q22)
- kronisk fase kronisk myelogen leukæmi
- tilbagevendende akut myeloid leukæmi hos voksne
- akut myeloid leukæmi hos voksne i remission
- recidiverende voksen Hodgkin lymfom
- recidiverende voksent diffust små spaltet celle lymfom
- recidiverende voksent diffust blandet celle lymfom
- recidiverende kronisk myelogen leukæmi
- tilbagevendende grad 1 follikulært lymfom
- tilbagevendende grad 2 follikulært lymfom
- tilbagevendende marginal zone lymfom
- tilbagevendende lille lymfocytisk lymfom
- ekstranodal marginal zone B-celle lymfom af slimhinde-associeret lymfoid væv
- nodal marginal zone B-celle lymfom
- milt marginal zone lymfom
- tilbagevendende lymfoblastisk lymfom hos voksne
- tilbagevendende kappecellelymfom
- refraktær kronisk lymfatisk leukæmi
- tilbagevendende kutant T-celle non-Hodgkin lymfom
- tilbagevendende voksen T-celle leukæmi/lymfom
- angioimmunoblastisk T-celle lymfom
- anaplastisk storcellet lymfom
- voksen nasal type ekstranodal NK/T-celle lymfom
- tilbagevendende voksen grad III lymfomatoid granulomatose
- refraktær myelomatose
- tilbagevendende akut lymfatisk leukæmi hos voksne
- accelereret fase kronisk myelogen leukæmi
- akut lymfatisk leukæmi hos voksne i remission
- graft versus host sygdom
- tilbagevendende grad I lymfomatoid granulomatose
- recidiverende grad II lymfomatoid granulomatose
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Hæmatologiske sygdomme
- Hæmoragiske lidelser
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Lymfom
- Myelomatose
- Neoplasmer, Plasmacelle
- Leukæmi
- Plasmacytom
- Graft vs værtssygdom
- Forstadier til kræft
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Enzymhæmmere
- Antirheumatiske midler
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Dermatologiske midler
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Antituberkulære midler
- Antibiotika, Antituberkulær
- Calcineurin-hæmmere
- Cyclofosfamid
- Fludarabin
- Fludarabin phosphat
- Mycophenolsyre
- Busulfan
- Antimfocyt serum
- Cyclosporin
- Cyclosporiner
Andre undersøgelses-id-numre
- CDR0000592923
- IPC-ITT-06-01
- INCA-RECF0627
- EUDRACT-2006-001369-14
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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