Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders

27. januar 2010 oppdatert av: Institut Paoli-Calmettes

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

Fase

Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Frankrike
- - Marseille, Frankrike, 13273
    - Rekruttering
    - Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
    - Ta kontakt med:
      
      Contact Person
      
      Telefonnummer: 33-4-91-22-37-54

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Ikke-randomisert
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Incidence of graft acceptance

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institut Paoli-Calmettes

Etterforskere

Studiestol: Didier Blaise, MD, Institut Paoli-Calmettes

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2008

Primær fullføring (Forventet)

1. januar 2010

Datoer for studieregistrering

Først innsendt

22. august 2008

Først innsendt som oppfylte QC-kriteriene