- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00619645
Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers
Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan
Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral 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 cells 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 and mycophenolate mofetil before and after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem cell transplant together with fludarabine and busulfan and to see how well it works in treating patients with hematologic cancers.
Studieoversigt
Status
Detaljeret beskrivelse
OUTLINE:
- Conditioning regimen: Patients receive busulfan IV over 3 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
- Allogeneic peripheral blood stem cell transplant (PBSC): Patients undergo allogeneic PBSC on day 0.
- Immunosuppressive therapy/graft-versus-host disease (GVHD) prophylaxis: Patients achieve100% donor T-cell chimerism on day 30 without disease recurrence, and cyclosporine A (CSA) IV continuously over 24 hours or orally every 12 hours on days -1 to 60 followed by a taper until day 100 and oral mycophenolate mofetil (MMF) once every 12 hours on days 1-40, in the absence of ≥ grade 2 GVHD.
Patients with recurrent disease or < 100% donor T-cell chimerism (on day 30) undergo a 12-day CSA and MMF taper followed by escalating doses of previously collected donor leukocyte infusion every 4 weeks until 100% donor T-cell chimerism or disease regression, in the absence of ≥ grade 2 GVHD.
After completion of study treatment, patients are followed periodically.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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California
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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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:
Diagnosed with any of the following:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
- Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required)
- In first complete remission (CR1) with poor-risk cytogenetics, antecedent hematological disease (i.e., myelodysplasia), or treatment-related leukemia
Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
- Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required)
- CR1 with Philadelphia chromosome or poor-risk cytogenetics
Chronic myelogenous leukemia (CML), meeting the following criteria:
First or second chronic phase
- Must be documented disease progression after imatinib mesylate therapy OR documented lack of cytogenetic response 6 months post-imatinib mesylate initiation OR imatinib mesylate intolerance
Chronic lymphocytic leukemia (CLL), meeting the following criteria:
Recurrent disease after fludarabine-based therapy
- Must have chemosensitive disease at the time of relapse, defined as greater than 50% reduction of WBC and lymphadenopathy
Recurrent Hodgkin lymphoma, recurrent non-Hodgkin lymphoma (NHL) (low-, intermediate-, or high-grade disease*), or transformed NHL, meeting 1 of the following criteria:
- Received prior autologous transplantation and cytoreductive therapy at the time of relapse to achieve complete remission (CR) or CR/unconfirmed (CRu) as defined by the International Workshop
- Relapsed disease that required more than 2 salvage regimens to achieve CR or CRu
Recurrent multiple myeloma, meeting the following criteria:
- Must have received prior autologous transplantation and demonstrate chemosensitivity at the time of relapse, defined as greater than 50% reduction of M-component or plasma-cell marrow infiltration
Myelodysplastic syndrome
Refractory anemia (RA)/RA with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD)/refractory cytopenia with multilineage dysplasia with ringed sideroblasts (RCMD-RS), or RA with excess blasts (RAEB) I, meeting the following criteria:
- Must be transfusion-dependent and have an IPSS score ≥ 1.5, based on WHO criteria
- No RAEB II or del(5q)
- No uncontrolled CNS metastases
- 5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor (both patient and donor) available
PATIENT CHARACTERISTICS:
- Karnofsky performance status ≥ 50%
- Serum creatinine ≤ 2 mg/dL
- Not pregnant
- Fertile patients must use effective contraception
50 years of age or older
Patients 18-50 years of age are eligible if meeting 1 of the following criteria:
- Have a preexisting medical condition
- Received prior therapy (i.e., autologous transplantation) and are considered to be too high risk for conventional myeloablative transplantation
- Must be willing to accept or comprehend irreversible sterility as a side effect of therapy
- No uncontrolled active infection
- No psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
- Cardiac ejection fraction ≥ 30%
- Corrected pulmonary-diffusing capacity ≥ 35%
- No serologic evidence of infection with HIV
- No decompensated liver disease with serum bilirubin > 2.0 mg/dL
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: RIST for Heme malignancies
Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Patients With Day 100 Transplant-related Mortality
Tidsramme: 24 months after day 100 transplant
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Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.
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24 months after day 100 transplant
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Patients Without Progression After Day 100 Transplant
Tidsramme: 24 months after day 100 transplant
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All patients will be followed for progression for 24 months after their day 100 transplant.
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24 months after day 100 transplant
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Number of Patients Alive 24 Months Post Day 100 Transplant
Tidsramme: 24 months post day 100 transplant
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Patients will be followed for survival for 24 months post day 100 transplant.
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24 months post day 100 transplant
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Carol M. Richman, MD, University of California, Davis
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- stadium III voksent diffust storcellet lymfom
- stadium III voksen immunoblastisk storcellet lymfom
- stadium III voksen Burkitt lymfom
- stadium IV grad 3 follikulært lymfom
- stadium IV voksent diffust storcellet lymfom
- stadium IV voksen immunoblastisk storcellet lymfom
- stadium IV voksen Burkitt lymfom
- tilbagevendende grad 3 follikulært lymfom
- tilbagevendende voksent diffust storcellet lymfom
- tilbagevendende voksen immunoblastisk storcellet lymfom
- recidiverende voksen Burkitt lymfom
- refraktær anæmi
- refraktær anæmi med ringmærkede sideroblaster
- refraktær anæmi med overskydende blaster
- de novo myelodysplastiske syndromer
- tidligere behandlede myelodysplastiske syndromer
- sekundære myelodysplastiske syndromer
- 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)
- sekundær akut myeloid leukæmi
- 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
- stadium III grad 1 follikulært lymfom
- stadium III grad 2 follikulært lymfom
- stadium III grad 3 follikulært lymfom
- stadium III voksent diffust små spaltet celle lymfom
- stadium III voksent diffust blandet celle lymfom
- stadium IV grad 1 follikulært lymfom
- stadium IV grad 2 follikulært lymfom
- stadium IV voksent diffust små spaltet celle lymfom
- stadium IV voksent diffust blandet celle lymfom
- stadium II myelomatose
- stadium III myelomatose
- tilbagevendende grad 1 follikulært lymfom
- tilbagevendende grad 2 follikulært lymfom
- tilbagevendende lille lymfocytisk lymfom
- stadium III lille lymfatisk lymfom
- stadium IV lille lymfocytisk lymfom
- stadium I myelomatose
- tilbagevendende lymfoblastisk lymfom hos voksne
- refraktær kronisk lymfatisk leukæmi
- stadium III kronisk lymfatisk leukæmi
- stadium IV kronisk lymfatisk leukæmi
- stadium III voksen Hodgkin lymfom
- stadium IV voksen Hodgkin lymfom
- stadium III voksen lymfoblastisk lymfom
- stadium IV voksen lymfoblastisk lymfom
- refraktær myelomatose
- tilbagevendende akut lymfatisk leukæmi hos voksne
- akut lymfatisk leukæmi hos voksne i remission
- refraktær cytopeni med multilineage dysplasi
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Sygdom
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Hæmoragiske lidelser
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Forstadier til kræft
- Lymfom
- Syndrom
- Myelodysplastiske syndromer
- Myelomatose
- Neoplasmer, Plasmacelle
- Leukæmi
- Præleukæmi
- Plasmacytom
- 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
- Fludarabin
- Fludarabin phosphat
- Mycophenolsyre
- Busulfan
- Cyclosporin
- Cyclosporiner
Andre undersøgelses-id-numre
- UCDCC#196
- 288263 (Anden identifikator: UC Davis)
- UCD-196 (Anden identifikator: UCDCC)
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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