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NCT06724237PHASE3Recruiting

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

Eastern Cooperative Oncology Group

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

Inclusion Criteria: * Patient must be 18 to 75 years of age * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories: * Anaplastic large cell lymphoma (ALCL) ALK-negative * Angioimmunoblastic T-cell lymphoma (AITL) * Nodal PTCL with follicular helper T cell (TFH) phenotype * Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) * Patient must have undergone induction treatment with an anthracycline based chemotherapy. * NOTE: Patients who discontinued anthracycline during treatment are eligible as long as they received at least one dose and achieved complete remission * Patient must have achieved radiologic complete remission following induction therapy as defined by the Lugano criteria with a Deauville score between 1-3 by PET-CT * NOTE: There is no central review required. Confirmation of complete remission status is determined by the enrolling institution's review * NOTE: If a patient had a positive bone marrow biopsy at the time of initial diagnosis (pre-induction), a repeat biopsy must be completed post induction to confirm complete remission (CR) * Patient must be eligible for high dose chemotherapy and autologous stem cell transplant (ASCT) per the enrolling institutional guidelines at the transplant center and be ready to proceed with ASCT if randomized to the ASCT arm * Patient must not have active infection requiring intravenous systemic antimicrobial at time of randomization. Antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7 days prior to randomization * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse during the treatment phase of the study and thereafter according to institutional guidelines * Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to protocol randomization) * Platelets ≥ 75,000/mcL (obtained ≤ 14 days prior to protocol randomization) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x institutional ULN (obtained ≤ 14 days prior to protocol randomization) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

OTHER

Best Practice

PROCEDURE

Biospecimen Collection

PROCEDURE

Bone Marrow Aspiration

PROCEDURE

Bone Marrow Biopsy

PROCEDURE

Computed Tomography

DRUG

High Dose Chemotherapy

PROCEDURE

Leukapheresis

PROCEDURE

Positron Emission Tomography

DRUG

Stem Cell Mobilization Therapy

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Conditions

Anaplastic Large Cell Lymphoma, ALK-NegativeFollicular Helper T-Cell LymphomaFollicular Helper T-Cell Lymphoma, Angioimmunoblastic-TypePeripheral T-Cell Lymphoma, Not Otherwise Specified

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

United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California 92612

United States

Contra Costa Regional Medical Center

Martinez, California 94553-3156

United States

Providence Queen of The Valley

Napa, California 94558

United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California 92868

United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California 95403

United States

Providence Santa Rosa Memorial Hospital

Santa Rosa, California 95405

United States

BASS Medical Group - Lennon

Walnut Creek, California 94598

United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado 80012

United States

Boulder Community Foothills Hospital

Boulder, Colorado 80303

United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado 80304

United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado 80112

United States

The Women's Imaging Center

Denver, Colorado 80209

United States

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado 80218

United States

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado 80218

United States

Rocky Mountain Cancer Centers-Rose

Denver, Colorado 80220

United States

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado 80113

United States

The Melanoma and Skin Cancer Institute

Englewood, Colorado 80113

United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado 80228

United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado 80120

United States

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado 80124

United States

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado 80501

United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado 80260

United States

Beebe Medical Center

Lewes, Delaware 19958

United States

Beebe South Coastal Health Campus

Millville, Delaware 19967

United States

Helen F Graham Cancer Center

Newark, Delaware 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware 19713

United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware 19718

United States

Beebe Health Campus

Rehoboth Beach, Delaware 19971

United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware 19801

United States

Mayo Clinic in Florida

Jacksonville, Florida 32224-9980

United States

Moffitt Cancer Center-International Plaza

Tampa, Florida 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida 33612

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho 83712

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho 83619

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho 83642

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho 83687

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho 83301

United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana 46202

United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa 52242

United States

University of Kansas Cancer Center

Kansas City, Kansas 66160

United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas 66210

United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas 66205

United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky 40202

United States

UofL Health Medical Center Northeast

Louisville, Kentucky 40245

United States

Mercy Health - Paducah Cancer Center

Paducah, Kentucky 42003

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana 70121

United States

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana 71103

United States

Christiana Care - Union Hospital

Elkton, Maryland 21921

United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan 48334

United States

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri 63376

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri 63141

United States

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri 64116

United States

University of Kansas Cancer Center - North

Kansas City, Missouri 64154

United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri 64064

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Siteman Cancer Center-South County

St Louis, Missouri 63129

United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri 63136

United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana 59802

United States

University of Rochester

Rochester, New York 14642

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina 27599

United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina 28203

United States

Novant Health Presbyterian Medical Center

Charlotte, North Carolina 28204

United States

Wake Forest University at Clemmons

Clemmons, North Carolina 27012

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Novant Health Cancer Institute - Huntersville

Huntersville, North Carolina 28078

United States

Novant Health Presbyterian Medical Center Huntersville

Huntersville, North Carolina 28078

United States

Novant Health Cancer Institute - Kernersville

Kernersville, North Carolina 27284

United States

Matthews Radiation Oncology Center

Matthews, North Carolina 28105

United States

Novant Health Cancer Institute - Matthews

Matthews, North Carolina 28105

United States

Novant Health Cancer Institute - Mooresville

Mooresville, North Carolina 28117

United States

Novant Health Cancer Institute - Mount Airy

Mount Airy, North Carolina 27030

United States

Novant Health Cancer Institute - Wilkesboro

North Wilkesboro, North Carolina 28659

United States

Rowan Regional Medical Center

Salisbury, North Carolina 28144

United States

Novant Health Cancer Institute - Statesville

Stateville, North Carolina 28625

United States

Novant Health Cancer Institute - Thomasville

Thomasville, North Carolina 27360

United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina 27103

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

OhioHealth O'Bleness Hospital

Athens, Ohio 45701

United States

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio 43214

United States

Riverside Methodist Hospital

Columbus, Ohio 43214

United States

Grant Medical Center

Columbus, Ohio 43215

United States

Doctors Hospital

Columbus, Ohio 43228

United States

Delaware Health Center-Grady Cancer Center

Delaware, Ohio 43015

United States

Grady Memorial Hospital

Delaware, Ohio 43015

United States

Columbus Oncology and Hematology Associates

Dublin, Ohio 43016

United States

Dublin Methodist Hospital

Dublin, Ohio 43016

United States

OhioHealth Mansfield Hospital

Mansfield, Ohio 44903

United States

OhioHealth Marion General Hospital

Marion, Ohio 43302

United States

OhioHealth Pickerington Methodist Hospital

Pickerington, Ohio 43147

United States

OhioHealth Westerville Medical Campus/Westerville Cancer Center

Westerville, Ohio 43082

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Saint Charles Health System

Bend, Oregon 97701

United States

Clackamas Radiation Oncology Center

Clackamas, Oregon 97015

United States

Bay Area Hospital

Coos Bay, Oregon 97420

United States

Providence Hood River Memorial Hospital

Hood River, Oregon 97031

United States

Providence Newberg Medical Center

Newberg, Oregon 97132

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon 97045

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon 97225

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Saint Charles Health System-Redmond

Redmond, Oregon 97756

United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania 19317

United States

Geisinger Medical Center

Danville, Pennsylvania 17822

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania 18711

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah 84112

United States

University of Virginia Cancer Center

Charlottesville, Virginia 22908

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia 23298

United States

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington 98520

United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington 98225

United States

Providence Regional Cancer System-Centralia

Centralia, Washington 98531

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington 98026

United States

Providence Regional Cancer Partnership

Everett, Washington 98201

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington 98029

United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington 99336

United States

Providence Regional Cancer System-Lacey

Lacey, Washington 98503

United States

PeaceHealth Saint John Medical Center

Longview, Washington 98632

United States

Skagit Regional Health Cancer Care Center

Mount Vernon, Washington 98274

United States

Jefferson Healthcare

Port Townsend, Washington 98368

United States

Swedish Medical Center-Ballard Campus

Seattle, Washington 98107

United States

Swedish Medical Center-Cherry Hill

Seattle, Washington 98122-5711

United States

Swedish Medical Center-First Hill

Seattle, Washington 98122

United States

PeaceHealth United General Medical Center

Sedro-Woolley, Washington 98284

United States

Cancer Care Northwest - Spokane South

Spokane, Washington 99202

United States

Cancer Care Northwest-Valley

Spokane, Washington 99216

United States

Cancer Care Northwest-North Spokane

Spokane, Washington 99218

United States

PeaceHealth Southwest Medical Center

Vancouver, Washington 98664

United States

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington 99362

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin 53792

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin 54449

United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin 53051

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin 53149

United States

Froedtert and MCW Moorland Reserve Health Center

New Berlin, Wisconsin 53151

United States

Drexel Town Square Health Center

Oak Creek, Wisconsin 53154

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin 53066

United States

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin 53188

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin 53188

United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin 53095

United States