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Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
filgrastim
rituximab
carmustine
cyclophosphamide
cytarabine
doxorubicin hydrochloride
etoposide
leucovorin calcium
methotrexate
prednisone
vincristine sulfate
peripheral blood stem cell transplantation
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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

Sites / Locations

  • Northeast Alabama Regional Medical Center
  • Veterans Affairs Medical Center - Birmingham
  • Rebecca and John Moores UCSD Cancer Center
  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
  • Naval Medical Center - San Diego
  • Veterans Affairs Medical Center - San Diego
  • UCSF Comprehensive Cancer Center
  • Veterans Affairs Medical Center - San Francisco
  • Hematology/Oncology Faculty Practice
  • CCOP - Christiana Care Health Services
  • Lombardi Cancer Center at Georgetown University Medical Center
  • Walter Reed Army Medical Center
  • Veterans Affairs Medical Center - Washington, DC
  • Broward General Medical Center
  • Memorial Regional Cancer Center at Memorial Regional Hospital
  • CCOP - Mount Sinai Medical Center
  • Palm Beach Cancer Institute
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • CCOP - Illinois Oncology Research Association
  • West Suburban Center for Cancer Care
  • Fort Wayne Medical Oncology and Hematology, Incorporated
  • CCOP - Northern Indiana CR Consortium
  • Holden Comprehensive Cancer Center at University of Iowa
  • Baptist Hospital East - Louisville
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • UMASS Memorial Cancer Center - University Campus
  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  • Veterans Affairs Medical Center - Minneapolis
  • University of Minnesota Cancer Center
  • Veterans Affairs Medical Center - Columbia (Truman Memorial)
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • CCOP - Kansas City
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • Missouri Baptist Cancer Center
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • CCOP - Southern Nevada Cancer Research Foundation
  • Veterans Affairs Medical Center - Las Vegas
  • New Hampshire Oncology-Hematology, PA - Hooksett
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Cooper University Hospital
  • Veterans Affairs Medical Center - Buffalo
  • Roswell Park Cancer Institute
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • Elmhurst Hospital Center
  • Queens Cancer Center of Queens Hospital
  • CCOP - North Shore University Hospital
  • North Shore University Hospital
  • Memorial Sloan-Kettering Cancer Center
  • New York Weill Cornell Cancer Center at Cornell University
  • Mount Sinai Medical Center
  • University Hospital at State University of New York - Upstate Medical University
  • Veterans Affairs Medical Center - Syracuse
  • Veterans Affairs Medical Center - Asheville
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • NorthEast Oncology Associates - Concord
  • Veterans Affairs Medical Center - Durham
  • Duke Comprehensive Cancer Center
  • Cape Fear Valley Health System
  • CCOP - Southeast Cancer Control Consortium
  • Lenoir Memorial Hospital Cancer Center
  • FirstHealth Moore Regional Hospital
  • Zimmer Cancer Center at New Hanover Regional Medical Center
  • Comprehensive Cancer Center at Wake Forest University
  • Arthur G. James Cancer Hospital at Ohio State University
  • Oklahoma University Medical Center
  • Western Pennsylvania Hospital
  • Lifespan: The Miriam Hospital
  • University of Tennessee Cancer Institute
  • Veterans Affairs Medical Center - Memphis
  • Veterans Affairs Medical Center - Dallas
  • Green Mountain Oncology Group
  • Vermont Cancer Center at University of Vermont
  • Martha Jefferson Hospital
  • Virginia Oncology Associates - Norfolk
  • MBCCOP - Massey Cancer Center
  • Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
  • St. Mary's Medical Center
  • Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemo/immuno/autolog transplant

Arm Description

Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Response
Survival
Disease free and overall survival

Full Information

First Posted
July 11, 2001
Last Updated
July 15, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00020943
Brief Title
Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Official Title
A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy For Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. 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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemo/immuno/autolog transplant
Arm Type
Experimental
Arm Description
Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma
Intervention Type
Biological
Intervention Name(s)
filgrastim
Other Intervention Name(s)
G-CSF
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Description
15 mg/kg IV infusion over 2 hours Day 6, Tx 4
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
cytarabine
Other Intervention Name(s)
ara-C
Intervention Description
2000 mg/sq m IV infusion BID over 2 hours x 8 doses Days 1-4, Tx 3
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Description
50 mg/sq m IVP Day 3, Tx 1& 2
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
40 mg/kg total dose continuous IV infusion over 96 hours Days 1-4, Tx 3
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
300 mg/sq m IV infusion over 4 hrs Day 2 Tx 1 & 2
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
100 mg/sq m PO Days 3-7, Tx 1 & 2
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Description
1.4 mg/sq m IVP Day 3, Tx 1 & 2
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Description
Stem cells collected during Tx 3 will be transfused follwing chemotx in Tx 4
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Response
Time Frame
2 years
Title
Survival
Description
Disease free and overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lloyd Damon, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
Northeast Alabama Regional Medical Center
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Veterans Affairs Medical Center - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1996
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Naval Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134-3202
Country
United States
Facility Name
Veterans Affairs Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Veterans Affairs Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Hematology/Oncology Faculty Practice
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0324
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lombardi Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
Veterans Affairs Medical Center - Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Memorial Regional Cancer Center at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago (Westside Hospital)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
West Suburban Center for Cancer Care
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Incorporated
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Baptist Hospital East - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
UMASS Memorial Cancer Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Veterans Affairs Medical Center - Columbia (Truman Memorial)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Veterans Affairs Medical Center - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
New Hampshire Oncology-Hematology, PA - Hooksett
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Queens Cancer Center of Queens Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University Hospital at State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
NorthEast Oncology Associates - Concord
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cape Fear Valley Health System
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28302-2000
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
Lenoir Memorial Hospital Cancer Center
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28503-1678
Country
United States
Facility Name
FirstHealth Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Zimmer Cancer Center at New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28402-9025
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Arthur G. James Cancer Hospital at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Lifespan: The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
University of Tennessee Cancer Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Veterans Affairs Medical Center - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Veterans Affairs Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Green Mountain Oncology Group
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Vermont Cancer Center at University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Martha Jefferson Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Virginia Oncology Associates - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
MBCCOP - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
St. Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
19917845
Citation
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.
Results Reference
result
PubMed Identifier
19021050
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
22102709
Citation
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.
Results Reference
derived

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Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

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