Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy
Start Date
1/30/2025
Completion Date
12/1/2033
Summary
This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.
Detailed Description
PRIMARY OBJECTIVE: I. To demonstrate improvement in progression free survival (PFS) in the autologous stem cell transplant (ASCT) arm compared to the observation arm. SECONDARY OBJECTIVES: I. To assess difference in overall survival (OS) between the observation and autologous stem cell transplant (ASCT) arm. II. To evaluate the differences in study intervention benefit for PFS and OS by the randomization stratification factors (histology and choice of induction chemotherapy). III. To evaluate the cumulative incidence of relapse and mortality between the observational and autologous stem cell transplant (ASCT) arm. EXPLORATORY OBJECTIVE: I. To determine the impact of minimal residual disease (MRD) on the benefit of autologous stem cell transplant (ASCT). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and computed tomography (CT) or positron emission tomography (PET)/CT throughout the study. ARM II: Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 7 years for a total of 12 years from the date of randomization.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Autologous Hematopoietic Stem Cell Transplantation
Best Practice
Biospecimen Collection
Bone Marrow Aspiration
Bone Marrow Biopsy
Computed Tomography
High Dose Chemotherapy
Leukapheresis
Positron Emission Tomography
Stem Cell Mobilization Therapy
Conditions
Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
United States
Alaska Women's Cancer Care
Anchorage, Alaska 99508
United States
Katmai Oncology Group
Anchorage, Alaska 99508
United States
Providence Alaska Medical Center
Anchorage, Alaska 99508
United States
Fairbanks Memorial Hospital
Fairbanks, Alaska 99701
United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010
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UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
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Contra Costa Regional Medical Center
Martinez, California 94553-3156
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Providence Queen of The Valley
Napa, California 94558
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UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
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Providence Medical Foundation - Santa Rosa
Santa Rosa, California 95403
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Providence Santa Rosa Memorial Hospital
Santa Rosa, California 95405
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BASS Medical Group - Lennon
Walnut Creek, California 94598
United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
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Boulder Community Foothills Hospital
Boulder, Colorado 80303
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Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
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Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado 80112
United States
The Women's Imaging Center
Denver, Colorado 80209
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Colorado Blood Cancer Institute
Denver, Colorado 80218
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Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado 80218
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Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218
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Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220
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Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado 80113
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The Melanoma and Skin Cancer Institute
Englewood, Colorado 80113
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Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado 80228
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Littleton, Colorado 80120
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Lone Tree, Colorado 80124
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Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado 80501
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Thornton, Colorado 80260
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Beebe Medical Center
Lewes, Delaware 19958
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Beebe South Coastal Health Campus
Millville, Delaware 19967
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Helen F Graham Cancer Center
Newark, Delaware 19713
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Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
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Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
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Beebe Health Campus
Rehoboth Beach, Delaware 19971
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Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
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Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
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Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
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Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
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Moffitt Cancer Center
Tampa, Florida 33612
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
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Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
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Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
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Meridian, Idaho 83642
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Nampa, Idaho 83687
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Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
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Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
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University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
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University of Kansas Cancer Center
Kansas City, Kansas 66160
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University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
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University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
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The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
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UofL Health Medical Center Northeast
Louisville, Kentucky 40245
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Mercy Health - Paducah Cancer Center
Paducah, Kentucky 42003
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Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
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LSU Health Sciences Center at Shreveport
Shreveport, Louisiana 71103
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Christiana Care - Union Hospital
Elkton, Maryland 21921
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Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
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Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
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Mayo Clinic in Rochester
Rochester, Minnesota 55905
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Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
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Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
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University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri 64116
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University of Kansas Cancer Center - North
Kansas City, Missouri 64154
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University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
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Washington University School of Medicine
St Louis, Missouri 63110
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Siteman Cancer Center-South County
St Louis, Missouri 63129
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Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
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Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
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University of Rochester
Rochester, New York 14642
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
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Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
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Novant Health Presbyterian Medical Center
Charlotte, North Carolina 28204
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Wake Forest University at Clemmons
Clemmons, North Carolina 27012
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Duke University Medical Center
Durham, North Carolina 27710
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Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina 28078
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Novant Health Presbyterian Medical Center Huntersville
Huntersville, North Carolina 28078
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Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina 27284
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Matthews Radiation Oncology Center
Matthews, North Carolina 28105
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Novant Health Cancer Institute - Matthews
Matthews, North Carolina 28105
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Mooresville, North Carolina 28117
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Mount Airy, North Carolina 27030
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North Wilkesboro, North Carolina 28659
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Rowan Regional Medical Center
Salisbury, North Carolina 28144
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Stateville, North Carolina 28625
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Thomasville, North Carolina 27360
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Oklahoma City, Oklahoma 73104
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Bend, Oregon 97701
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Clackamas, Oregon 97015
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Oregon City, Oregon 97045
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Portland, Oregon 97225
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Redmond, Oregon 97756
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Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
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Geisinger Medical Center
Danville, Pennsylvania 17822
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Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
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Medical University of South Carolina
Charleston, South Carolina 29425
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
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University of Virginia Cancer Center
Charlottesville, Virginia 22908
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VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
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Providence Regional Cancer Partnership
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Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
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Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
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Port Townsend, Washington 98368
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Vancouver, Washington 98664
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West Bend, Wisconsin 53095
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