Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
NCT ID: NCT00020943
Last Updated: 2016-07-19
Study Results
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Basic Information
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COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2001-06-30
2009-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and rituximab with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.
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Detailed Description
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* Determine the two-year progression-free survival of patients with mantle cell lymphoma treated with intensive chemotherapy and rituximab with autologous peripheral blood stem cell (PBSC) transplantation.
* Determine the complete and partial response rates of patients treated with this regimen.
* Determine the disease-free and overall survival of patients treated with this regimen.
* Determine the autologous immune reconstitution in patients treated with this regimen.
* Determine the feasibility of this regimen in this patient population.
* Determine whether treatment with rituximab during autologous PBSC transplantation reduces the amount of contaminating lymphoma in the autologous PBSC product.
OUTLINE: This is a multicenter study.
Patients receive induction therapy comprising rituximab IV over 4-6 hours on day 1; methotrexate IV over 4 hours on day 2; cyclophosphamide IV over 2 hours, doxorubicin IV, and vincristine IV on day 3; and oral prednisone on days 3-7. Patients also receive leucovorin calcium IV every 6 hours beginning on day 3 and continuing until blood levels of methotrexate are safe. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 4 and continuing until blood counts recover.
Induction therapy repeats every 21-28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Rituximab may be omitted during course 1 if circulating mantle cells are excessive. Patients may receive a third course if more than 15% persistent bone marrow involvement is documented.
Patients with stable or responding disease begin consolidation therapy 29 days after the start of the final course of induction therapy. Patients receive cytarabine IV over 2 hours twice daily and etoposide IV over 96 hours on days 1-4. Patients also receive rituximab IV over 4-6 hours on days 5 or 6 and 12 or 13 and G-CSF SC beginning on day 14 and continuing until leukapheresis is complete. Patients undergo leukapheresis beginning between days 22-25 and continuing until adequate CD34 cells are collected.
Beginning 4 weeks after recovery from consolidation therapy, patients receive high-dose therapy comprising carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2. Patients undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover.
After blood counts recover and more than 35 days after autologous PBSC transplantation, patients receive rituximab IV over 4-6 hours weekly for 2 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for up to 10 years.
PROJECTED ACCRUAL: At least 45 patients will be accrued for this study within 2 years.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemo/immuno/autolog transplant
Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma
filgrastim
5 ug/kg subQ daily day 4 until ANC \>10,000 (or ANC\> 5000 2X)Tx 1, 2, 4 10 ug/kg subQ daily day 14 until completion of PBSC collection Tx 3
rituximab
375 mg/sq m IV infusion at , or = 400 mg/hr day 1 Tx 1, 2, days 5 \& 12 Tx 3, and weekly for 2 doses Tx 5
carmustine
15 mg/kg IV infusion over 2 hours Day 6, Tx 4
cyclophosphamide
2000 mg/sq m IV infusion over 2 hours Day 3, Tx 1 \& 2 100 mg/kg IV infusion over 2 hours Day 2, Tx 4
cytarabine
2000 mg/sq m IV infusion BID over 2 hours x 8 doses Days 1-4, Tx 3
doxorubicin hydrochloride
50 mg/sq m IVP Day 3, Tx 1\& 2
etoposide
40 mg/kg total dose continuous IV infusion over 96 hours Days 1-4, Tx 3
leucovorin calcium
50 mg/sq m IV infusion q 6 hours x 3 doses after MTX, then 10 mg/sq m IV/PO q 6 hrs until MTX levels \<0.05 uM, Tx 1 \& 2
methotrexate
300 mg/sq m IV infusion over 4 hrs Day 2 Tx 1 \& 2
prednisone
100 mg/sq m PO Days 3-7, Tx 1 \& 2
vincristine sulfate
1.4 mg/sq m IVP Day 3, Tx 1 \& 2
peripheral blood stem cell transplantation
Stem cells collected during Tx 3 will be transfused follwing chemotx in Tx 4
Interventions
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filgrastim
5 ug/kg subQ daily day 4 until ANC \>10,000 (or ANC\> 5000 2X)Tx 1, 2, 4 10 ug/kg subQ daily day 14 until completion of PBSC collection Tx 3
rituximab
375 mg/sq m IV infusion at , or = 400 mg/hr day 1 Tx 1, 2, days 5 \& 12 Tx 3, and weekly for 2 doses Tx 5
carmustine
15 mg/kg IV infusion over 2 hours Day 6, Tx 4
cyclophosphamide
2000 mg/sq m IV infusion over 2 hours Day 3, Tx 1 \& 2 100 mg/kg IV infusion over 2 hours Day 2, Tx 4
cytarabine
2000 mg/sq m IV infusion BID over 2 hours x 8 doses Days 1-4, Tx 3
doxorubicin hydrochloride
50 mg/sq m IVP Day 3, Tx 1\& 2
etoposide
40 mg/kg total dose continuous IV infusion over 96 hours Days 1-4, Tx 3
leucovorin calcium
50 mg/sq m IV infusion q 6 hours x 3 doses after MTX, then 10 mg/sq m IV/PO q 6 hrs until MTX levels \<0.05 uM, Tx 1 \& 2
methotrexate
300 mg/sq m IV infusion over 4 hrs Day 2 Tx 1 \& 2
prednisone
100 mg/sq m PO Days 3-7, Tx 1 \& 2
vincristine sulfate
1.4 mg/sq m IVP Day 3, Tx 1 \& 2
peripheral blood stem cell transplantation
Stem cells collected during Tx 3 will be transfused follwing chemotx in Tx 4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed mantle cell lymphoma
* Presenting with at least one of the following:
* Coexpression of CD20 (or CD19) and CD5 and a lack of CD23 expression by immunophenotyping
* Positive for cyclin D1 by immunostaining
* Presence of t(11,14) by cytogenetic analysis
* Molecular evidence of bcl-1/IgH rearrangement
* Stage I-IV disease
* Stage III or IV if nodular histology mantle cell lymphoma present
* Any stage for other mantle cell histologies
* No mantle zone histology
* No active CNS disease
* No symptomatic meningeal lymphoma
* No known CNS parenchymal lymphoma
* Lumbar puncture showing mantle cell lymphoma allowed
* Bidimensionally measurable disease greater than 1 cm
* Nonmeasurable disease includes the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* Lesions in a previously irradiated area
PATIENT CHARACTERISTICS:
Age:
* 18 to 69
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Hepatitis B surface antigen and hepatitis C antibody positive patients must meet all of the following criteria:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST no greater than 3 times ULN
* Liver biopsy shows no greater than grade 2 fibrosis and no cirrhosis
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* LVEF at least 45% by MUGA or echocardiogram
Other:
* No known hypersensitivity to murine products
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No more than 1 prior dose of rituximab
Chemotherapy:
* No more than 1 prior cycle of chemotherapy
* At least 3 weeks since prior chemotherapy
* No other concurrent chemotherapeutic agents
Endocrine therapy:
* No chronic use of oral corticosteroids for ongoing medical condition
* No concurrent hormonal therapy except for non-lymphoma-related conditions (e.g., insulin for diabetes)
* Other concurrent corticosteroids for adrenal failure, diffuse alveolar hemorrhage, carmustine pneumonitis, or as an anti-emetic allowed
Radiotherapy:
* No prior radiotherapy for mantle cell lymphoma
* Concurrent palliative radiotherapy allowed
* Concurrent cranial radiotherapy for asymptomatic meningeal lymphoma allowed
Surgery:
* At least 2 weeks since prior major surgery
18 Years
69 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Lloyd Damon, MD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
Hematology/Oncology Faculty Practice
San Francisco, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
University Hospital at State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
NorthEast Oncology Associates - Concord
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital at Ohio State University
Columbus, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Green Mountain Oncology Group
Bennington, Vermont, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
San Juan, , Puerto Rico
Countries
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References
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Damon LE, Johnson JL, Niedzwiecki D, Cheson BD, Hurd DD, Bartlett NL, Lacasce AS, Blum KA, Byrd JC, Kelly M, Stock W, Linker CA, Canellos GP. Immunochemotherapy and autologous stem-cell transplantation for untreated patients with mantle-cell lymphoma: CALGB 59909. J Clin Oncol. 2009 Dec 20;27(36):6101-8. doi: 10.1200/JCO.2009.22.2554. Epub 2009 Nov 16.
Hsi ED, Jung SH, Lai R, Johnson JL, Cook JR, Jones D, Devos S, Cheson BD, Damon LE, Said J. Ki67 and PIM1 expression predict outcome in mantle cell lymphoma treated with high dose therapy, stem cell transplantation and rituximab: a Cancer and Leukemia Group B 59909 correlative science study. Leuk Lymphoma. 2008 Nov;49(11):2081-90. doi: 10.1080/10428190802419640.
Damon LE, Johnson J, Niedzwiecki D, et al.: Immuno-chemotherapy (IC) and autologous stem cell transplant (ASCT) for untreated patients (pts) with mantle cell lymphoma (MCL): CALGB 59909. [Abstract] Blood 108 (11): A-2737, 2006.
Liu H, Johnson JL, Koval G, Malnassy G, Sher D, Damon LE, Hsi ED, Bucci DM, Linker CA, Cheson BD, Stock W. Detection of minimal residual disease following induction immunochemotherapy predicts progression free survival in mantle cell lymphoma: final results of CALGB 59909. Haematologica. 2012 Apr;97(4):579-85. doi: 10.3324/haematol.2011.050203. Epub 2011 Nov 18.
Other Identifiers
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CALGB-59909
Identifier Type: -
Identifier Source: secondary_id
CDR0000068732
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-59909
Identifier Type: -
Identifier Source: org_study_id
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