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- Klinische proef 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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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California
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Sacramento, California, Verenigde Staten, 95817
- University of California Davis Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Patients With Day 100 Transplant-related Mortality
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Patients Without Progression After Day 100 Transplant
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Carol M. Richman, MD, University of California, Davis
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- stadium III volwassen diffuus grootcellig lymfoom
- stadium III volwassen immunoblastisch grootcellig lymfoom
- stadium III volwassen Burkitt-lymfoom
- stadium IV graad 3 folliculair lymfoom
- stadium IV volwassen diffuus grootcellig lymfoom
- stadium IV volwassen immunoblastisch grootcellig lymfoom
- stadium IV volwassen Burkitt-lymfoom
- recidiverend graad 3 folliculair lymfoom
- recidiverend diffuus grootcellig lymfoom bij volwassenen
- recidiverend volwassen immunoblastisch grootcellig lymfoom
- recidiverend volwassen Burkitt-lymfoom
- refractaire bloedarmoede
- refractaire anemie met geringde sideroblasten
- vuurvaste bloedarmoede met overmatige ontploffing
- de novo myelodysplastische syndromen
- eerder behandelde myelodysplastische syndromen
- secundaire myelodysplastische syndromen
- volwassen acute myeloïde leukemie met 11q23 (MLL) afwijkingen
- volwassen acute myeloïde leukemie met inv(16)(p13;q22)
- volwassen acute myeloïde leukemie met t(15;17)(q22;q12)
- volwassen acute myeloïde leukemie met t(16;16)(p13;q22)
- volwassen acute myeloïde leukemie met t(8;21)(q22;q22)
- secundaire acute myeloïde leukemie
- chronische fase chronische myeloïde leukemie
- recidiverende volwassen acute myeloïde leukemie
- volwassen acute myeloïde leukemie in remissie
- recidiverend volwassen Hodgkin-lymfoom
- recidiverend diffuus kleincellig lymfoom bij volwassenen
- recidiverend diffuus gemengd cellymfoom bij volwassenen
- recidiverende chronische myeloïde leukemie
- stadium III graad 1 folliculair lymfoom
- stadium III graad 2 folliculair lymfoom
- stadium III graad 3 folliculair lymfoom
- stadium III diffuus kleincellig lymfoom bij volwassenen
- stadium III volwassen diffuus gemengd cellymfoom
- stadium IV graad 1 folliculair lymfoom
- stadium IV graad 2 folliculair lymfoom
- stadium IV volwassen diffuus klein-gesplitst cellymfoom
- stadium IV volwassen diffuus gemengd cellymfoom
- stadium II multipel myeloom
- stadium III multipel myeloom
- recidiverend graad 1 folliculair lymfoom
- recidiverend graad 2 folliculair lymfoom
- terugkerend klein lymfocytisch lymfoom
- stadium III klein lymfocytisch lymfoom
- stadium IV klein lymfocytisch lymfoom
- stadium I multipel myeloom
- recidiverend volwassen lymfoblastisch lymfoom
- refractaire chronische lymfatische leukemie
- stadium III chronische lymfatische leukemie
- stadium IV chronische lymfatische leukemie
- stadium III volwassen Hodgkin-lymfoom
- stadium IV volwassen Hodgkin-lymfoom
- stadium III volwassen lymfoblastisch lymfoom
- stadium IV volwassen lymfoblastisch lymfoom
- refractair multipel myeloom
- recidiverende volwassen acute lymfatische leukemie
- volwassen acute lymfatische leukemie in remissie
- refractaire cytopenie met multilineaire dysplasie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Hart-en vaatziekten
- Vaatziekten
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Ziekte
- Beenmergziekten
- Hematologische ziekten
- Hemorragische aandoeningen
- Hemostatische aandoeningen
- Paraproteïnemieën
- Bloed eiwit stoornissen
- Voorstadia van kanker
- Lymfoom
- Syndroom
- Myelodysplastische syndromen
- Multipel myeloom
- Neoplasmata, plasmacel
- Leukemie
- Preleukemie
- Plasmacytoom
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Enzymremmers
- Antireumatische middelen
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Dermatologische middelen
- Antibacteriële middelen
- Antibiotica, antineoplastiek
- Antischimmelmiddelen
- Antituberculeuze middelen
- Antibiotica, antituberculair
- Calcineurineremmers
- Fludarabine
- Fludarabine-fosfaat
- Mycofenolzuur
- Busulfan
- Cyclosporine
- Cyclosporines
Andere studie-ID-nummers
- UCDCC#196
- 288263 (Andere identificatie: UC Davis)
- UCD-196 (Andere identificatie: UCDCC)
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