- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
California
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Patients With Day 100 Transplant-related Mortality
Tidsram: 24 months after day 100 transplant
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Patients Without Progression After Day 100 Transplant
Tidsram: 24 months after day 100 transplant
|
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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Carol M. Richman, MD, University of California, Davis
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- stadium III vuxen diffust storcelligt lymfom
- stadium III vuxen immunoblastiskt storcelligt lymfom
- stadium III vuxen Burkitt lymfom
- stadium IV grad 3 follikulärt lymfom
- stadium IV vuxen diffust storcelligt lymfom
- stadium IV vuxen immunoblastiskt storcelligt lymfom
- stadium IV vuxen Burkitt lymfom
- återkommande follikulärt lymfom grad 3
- återkommande vuxen diffust storcelligt lymfom
- återkommande vuxen immunoblastiskt storcelligt lymfom
- återkommande vuxen Burkitt lymfom
- refraktär anemi
- refraktär anemi med ringade sideroblaster
- refraktär anemi med överskott av blaster
- de novo myelodysplastiska syndrom
- tidigare behandlade myelodysplastiska syndrom
- sekundära myelodysplastiska syndrom
- akut myeloid leukemi hos vuxna med 11q23 (MLL) abnormiteter
- akut myeloid leukemi hos vuxna med inv(16)(p13;q22)
- akut myeloid leukemi hos vuxna med t(15;17)(q22;q12)
- akut myeloid leukemi hos vuxna med t(16;16)(p13;q22)
- akut myeloid leukemi hos vuxna med t(8;21)(q22;q22)
- sekundär akut myeloid leukemi
- kronisk myelogen leukemi i kronisk fas
- återkommande akut myeloid leukemi hos vuxna
- akut myeloid leukemi hos vuxna i remission
- återkommande vuxen Hodgkin-lymfom
- återkommande vuxen diffusa små kluvna lymfom
- återkommande diffust blandat celllymfom hos vuxna
- återfallande kronisk myelogen leukemi
- stadium III grad 1 follikulärt lymfom
- stadium III grad 2 follikulärt lymfom
- stadium III grad 3 follikulärt lymfom
- stadium III vuxen diffust småklyvt lymfom
- stadium III diffust blandat celllymfom hos vuxna
- stadium IV grad 1 follikulärt lymfom
- stadium IV grad 2 follikulärt lymfom
- stadium IV vuxen diffust småklyvt lymfom
- stadium IV diffust blandat celllymfom hos vuxna
- stadium II multipelt myelom
- stadium III multipelt myelom
- återkommande follikulärt lymfom grad 1
- återkommande follikulärt lymfom grad 2
- återkommande små lymfocytiska lymfom
- stadium III små lymfocytiska lymfom
- stadium IV små lymfocytiska lymfom
- stadium I multipelt myelom
- återkommande lymfoblastiskt lymfom hos vuxna
- refraktär kronisk lymfatisk leukemi
- stadium III kronisk lymfatisk leukemi
- stadium IV kronisk lymfatisk leukemi
- stadium III vuxen Hodgkin lymfom
- stadium IV vuxen Hodgkin lymfom
- stadium III vuxen lymfoblastiskt lymfom
- stadium IV vuxen lymfoblastiskt lymfom
- refraktärt multipelt myelom
- återkommande akut lymfatisk leukemi hos vuxna
- vuxen akut lymfatisk leukemi i remission
- refraktär cytopeni med multilineage dysplasi
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Sjukdom
- Benmärgssjukdomar
- Hematologiska sjukdomar
- Hemorragiska störningar
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Precancerösa tillstånd
- Lymfom
- Syndrom
- Myelodysplastiska syndrom
- Multipelt myelom
- Neoplasmer, Plasmacell
- Leukemi
- Preleukemi
- Plasmacytom
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Enzyminhibitorer
- Antireumatiska medel
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Dermatologiska medel
- Antibakteriella medel
- Antibiotika, antineoplastiska
- Antifungala medel
- Antituberkulära medel
- Antibiotika, Antituberkulära
- Calcineurin-hämmare
- Fludarabin
- Fludarabinfosfat
- Mykofenolsyra
- Busulfan
- Cyklosporin
- Cyklosporiner
Andra studie-ID-nummer
- UCDCC#196
- 288263 (Annan identifierare: UC Davis)
- UCD-196 (Annan identifierare: UCDCC)
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