- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00006747
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
OBJECTIVES:
- Determine the long term disease-free survival of patients with mantle cell lymphoma treated with etoposide, carmustine, melphalan, and cytarabine followed by allogeneic peripheral blood stem cell transplantation.
- Determine the incidence of molecular remissions in these patients treated with this regimen.
- Correlate the persistence of minimal residual disease with clinical outcome in these patients treated with this regimen.
- Determine the effect of donor lymphocytes in patients with progressive disease after treatment with this regimen.
OUTLINE: This is a multicenter study.
Patients receive carmustine IV over 2 hours on day -6; etoposide IV over 3 hours and cytarabine IV over 1 hour every 12 hours on days -5 to -2 for a total of 8 doses; and melphalan IV over 20-30 minutes on day -1. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplantation on day 0. Patients also receive tacrolimus IV continuously over 24 hours beginning on day -2 and then orally twice daily until day 120 and methotrexate IV over 30 minutes on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis. Patients receive sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 7 and continuing until blood counts recover.
Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours. Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists.
Patients are followed at 6 and 12 months posttransplantation and then annually for 4 years.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233-1996
- Veterans Affairs Medical Center - Birmingham
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California
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La Jolla, California, Förenta staterna, 92093-0658
- University of California San Diego Cancer Center
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San Francisco, California, Förenta staterna, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, Förenta staterna, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, Förenta staterna, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Förenta staterna, 20007
- Lombardi Cancer Center
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Florida
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Miami Beach, Florida, Förenta staterna, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- University of Illinois at Chicago
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Chicago, Illinois, Förenta staterna, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Förenta staterna, 60637-1470
- University of Chicago Cancer Research Center
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Iowa
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Iowa City, Iowa, Förenta staterna, 52242-1009
- Holden Comprehensive Cancer Center
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Maine
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Togus, Maine, Förenta staterna, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, Förenta staterna, 01655
- University of Massachusetts Memorial Medical Center - University Campus
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, Förenta staterna, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, Förenta staterna, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Förenta staterna, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68198-7680
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Förenta staterna, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, Förenta staterna, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, Förenta staterna, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Förenta staterna, 11030
- North Shore University Hospital
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New York, New York, Förenta staterna, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Förenta staterna, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, Förenta staterna, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, Förenta staterna, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, Förenta staterna, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, Förenta staterna, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Förenta staterna, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Förenta staterna, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Förenta staterna, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Förenta staterna, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, Förenta staterna, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02903
- Rhode Island Hospital
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38104
- Veterans Affairs Medical Center - Memphis
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Memphis, Tennessee, Förenta staterna, 38103
- University of Tennessee Cancer Institute
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Vermont
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Bennington, Vermont, Förenta staterna, 05201
- Green Mountain Oncology Group
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Burlington, Vermont, Förenta staterna, 05401-3498
- Vermont Cancer Center
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White River Junction, Vermont, Förenta staterna, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, Förenta staterna, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, Förenta staterna, 23249
- Veterans Affairs Medical Center - Richmond
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Documentation of Disease
Histologically documented mantle cell lymphoma of any stage (needle or core biopsy is not acceptable as the sole means of diagnosis) with at least one of the following confirmatory tests indicative of diagnosis:
- Immunophenotype with expression of CD5 and CD19 and absence of CD23
- Cytogenetic analysis with presence of t(11;14)
- Overexpression of cyclin D1
- Rearrangement of BCL1 gene
- Rebiopsy of a node at relapse is recommended but not required.
- Bone marrow biopsy required for pretreatment evaluation. Bilateral biopsies are not required.
- Identification of HLA-Matched sibling donor - The sibling donor must meet eligibility criteria outlined in section 5.0
Prior Therapy
Patients who have failed initial therapy are eligible (without any of the poor prognostic characteristics listed in the protocol). Failure to initial treatment is defined as one of the following:
- Failure to achieve clinical complete remission after treatment with an anthracycline-containing regimen
- Disease recurrence after initial treatment (with an anthracycline-containing regimen)
Patients in first remission must have one of the following poor prognostic characteristics:
- International Prognostic Index (IPI) score > 1. IPI risk factors include the following: age > 60 (not eligible for this protocol); performance status > 1; LDH > normal; presence of > 1 extranodal sites; and stage III/IV disease
- Blastic variant of mantle cell lymphoma (regardless of IPI score)
- Complex karyotypes (i.e., cytogenetic abnormalities different from or in addition to t(11;14) (regardless of IPI score)
- Proliferative index > 10% (regardless of IPI score)
- Presence of p53 mutations
- Patients who have received more than two chemotherapy regimens are ineligible. Patients who have undergone a prior bone marrow transplant are not eligible.
- Age < 60 years
- No active CNS lymphoma
- DLCO ≥ 40% and no symptomatic pulmonary disease
- No HIV infection
- Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.
Initial required laboratory values
- bilirubin < 2 mg/dl
- AST ≤ 3 x upper limit of normal (ULN)
- ALT ≤ 3 x ULN
- serum creatinine < 2 mg/dl
- u-HCG or serum HCG negative (if patient of childbearing potential)
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 |
---|---|
Experimentell: chemotherapy + stem cell transplantation
Patients receive carmustine, etoposide, cytarabine and melphalan on day -1. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplantation on day 0. Patients also receive tacrolimus on day -2 and then orally twice daily until day 120 and methotrexate on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis. Patients receive sargramostim daily beginning on day 7 and continuing until blood counts recover. Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours. Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists. Patients are followed at 6 and 12 months post-transplantation and then annually for 4 years. |
IV
IV
IV
IV
IV
IV
IV
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
disease free survival
Tidsram: up to 5 years post-transplant
|
up to 5 years post-transplant
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Koen Van Besien, MD, University of Chicago
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 (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom, icke-Hodgkin
- Lymfom
- Lymfom, mantelcell
- Graft vs Host Disease
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Antireumatiska medel
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Antineoplastiska medel, fytogena
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Dermatologiska medel
- Reproduktionskontrollmedel
- Abortframkallande medel, icke-steroida
- Abortmedel
- Folsyraantagonister
- Calcineurin-hämmare
- Etoposid
- Melphalan
- Cytarabin
- Metotrexat
- Takrolimus
- Karmustin
- Sargramostim
Andra studie-ID-nummer
- CALGB-59908
- U10CA031946 (U.S.S. NIH-anslag/kontrakt)
- CLB-59908
- CDR0000068324 (Registeridentifierare: NCI Physician Data Query)
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