Home › Anaplastic Large-Cell Lymphoma › NCT06724237
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
RecruitingPhase 3
A Randomized Phase III Study to Evaluate Benefits of Autologous Stem Cell Transplant in Patients With Peripheral T Cell Lymphoma That Achieved a First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Autologous Hematopoietic Stem Cell Transplantation (procedure)
- Best Practice (other)
- Biospecimen Collection (procedure)
- Bone Marrow Aspiration (procedure)
- Bone Marrow Biopsy (procedure)
- Computed Tomography (procedure)
Sponsor: Eastern Cooperative Oncology Group · Participants: 294 · Started: Jun 18, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06724237
Locations in the U.S.
| Alabama | University of Alabama at Birmingham Cancer Center, Birmingham (Not yet recruiting) |
| Alaska | Alaska Breast Care and Surgery LLC, Anchorage Alaska Oncology and Hematology LLC, Anchorage Alaska Women's Cancer Care, Anchorage Anchorage Associates in Radiation Medicine, Anchorage Katmai Oncology Group, Anchorage Providence Alaska Medical Center, Anchorage |
| Arizona | Mayo Clinic Hospital in Arizona, Phoenix Banner University Medical Center - Tucson, Tucson University of Arizona Cancer Center-North Campus, Tucson |
| California | Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank City of Hope Comprehensive Cancer Center, Duarte UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine Providence Queen of The Valley, Napa UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange Providence Medical Foundation - Santa Rosa, Santa Rosa Providence Santa Rosa Memorial Hospital, Santa Rosa |
| Delaware | Beebe Medical Center, Lewes Beebe South Coastal Health Campus, Millville Christiana Care Health System-Christiana Hospital, Newark Helen F Graham Cancer Center, Newark Medical Oncology Hematology Consultants PA, Newark Beebe Health Campus, Rehoboth Beach Christiana Care Health System-Wilmington Hospital, Wilmington |
| District of Columbia | Sibley Memorial Hospital, Washington D.C. |
| Florida | Mayo Clinic in Florida, Jacksonville Moffitt Cancer Center, Tampa Moffitt Cancer Center - McKinley Campus, Tampa Moffitt Cancer Center-International Plaza, Tampa |
| Georgia | Emory University Hospital/Winship Cancer Institute, Atlanta |
| Idaho | Saint Luke's Cancer Institute - Boise, Boise Saint Luke's Cancer Institute - Fruitland, Fruitland Saint Luke's Cancer Institute - Meridian, Meridian Saint Luke's Cancer Institute - Nampa, Nampa Saint Luke's Cancer Institute - Twin Falls, Twin Falls |
| Illinois | Loyola Center for Health at Burr Ridge, Burr Ridge Loyola Medicine Homer Glen, Homer Glen Loyola University Medical Center, Maywood Marjorie Weinberg Cancer Center at Loyola-Gottlieb, Melrose Park |
| Indiana | Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis |
| Iowa | University of Iowa/Holden Comprehensive Cancer Center, Iowa City |
| Kansas | University of Kansas Cancer Center, Kansas City University of Kansas Cancer Center-Overland Park, Overland Park University of Kansas Hospital-Westwood Cancer Center, Westwood |
| Kentucky | The James Graham Brown Cancer Center at University of Louisville, Louisville UofL Health Medical Center Northeast, Louisville |
| Louisiana | Ochsner Medical Center Jefferson, New Orleans LSU Health Sciences Center at Shreveport, Shreveport |
| Maryland | Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore Christiana Care - Union Hospital, Elkton |
| Michigan | Wayne State University/Karmanos Cancer Institute, Detroit Weisberg Cancer Treatment Center, Farmington Hills |
| Minnesota | Mayo Clinic in Rochester, Rochester |
| Missouri | Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters Siteman Cancer Center at West County Hospital, Creve Coeur University of Kansas Cancer Center - Briarcliff, Kansas City University of Kansas Cancer Center - North, Kansas City University of Kansas Cancer Center - Lee's Summit, Lee's Summit Siteman Cancer Center at Christian Hospital, St Louis Siteman Cancer Center-South County, St Louis Washington University School of Medicine, St Louis |
| Montana | Saint Patrick Hospital - Community Hospital, Missoula |
| New York | University of Rochester, Rochester |
| North Carolina | UNC Lineberger Comprehensive Cancer Center, Chapel Hill Carolinas Medical Center/Levine Cancer Institute, Charlotte Novant Health Presbyterian Medical Center, Charlotte Wake Forest University at Clemmons, Clemmons Duke University Medical Center, Durham Novant Health Cancer Institute - Huntersville, Huntersville Novant Health Presbyterian Medical Center Huntersville, Huntersville Novant Health Cancer Institute - Kernersville, Kernersville Matthews Radiation Oncology Center, Matthews Novant Health Cancer Institute - Matthews, Matthews Novant Health Cancer Institute - Mooresville, Mooresville Novant Health Cancer Institute - Mount Airy, Mount Airy Novant Health Cancer Institute - Wilkesboro, North Wilkesboro Rowan Regional Medical Center, Salisbury Novant Health Cancer Institute - Statesville, Stateville Novant Health Cancer Institute - Thomasville, Thomasville Novant Health Forsyth Medical Center, Winston-Salem Wake Forest University Health Sciences, Winston-Salem |
| Ohio | OhioHealth O'Bleness Hospital, Athens Columbus Oncology and Hematology Associates Inc, Columbus Doctors Hospital, Columbus Grant Medical Center, Columbus Riverside Methodist Hospital, Columbus Delaware Health Center-Grady Cancer Center, Delaware Grady Memorial Hospital, Delaware Columbus Oncology and Hematology Associates, Dublin Dublin Methodist Hospital, Dublin OhioHealth Mansfield Hospital, Mansfield OhioHealth Marion General Hospital, Marion OhioHealth Pickerington Methodist Hospital, Pickerington OhioHealth Westerville Medical Campus/Westerville Cancer Center, Westerville |
| Oklahoma | University of Oklahoma Health Sciences Center, Oklahoma City |
| Oregon | Saint Charles Health System, Bend Clackamas Radiation Oncology Center, Clackamas Bay Area Hospital, Coos Bay Providence Hood River Memorial Hospital, Hood River Providence Newberg Medical Center, Newberg Providence Willamette Falls Medical Center, Oregon City Providence Portland Medical Center, Portland Providence Saint Vincent Medical Center, Portland Saint Charles Health System-Redmond, Redmond |
| Pennsylvania | Christiana Care Health System-Concord Health Center, Chadds Ford Geisinger Medical Center, Danville Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre |
| South Carolina | Medical University of South Carolina, Charleston |
| Utah | Huntsman Cancer Institute/University of Utah, Salt Lake City |
| Virginia | University of Virginia Cancer Center, Charlottesville VCU Massey Comprehensive Cancer Center, Richmond |
| Washington | Providence Regional Cancer System-Aberdeen, Aberdeen PeaceHealth Saint Joseph Medical Center, Bellingham Providence Regional Cancer System-Centralia, Centralia Swedish Cancer Institute-Edmonds, Edmonds Providence Regional Cancer Partnership, Everett Swedish Cancer Institute-Issaquah, Issaquah Kadlec Clinic Hematology and Oncology, Kennewick Providence Regional Cancer System-Lacey, Lacey PeaceHealth Saint John Medical Center, Longview Skagit Regional Health Cancer Care Center, Mount Vernon Swedish Medical Center-Ballard Campus, Seattle Swedish Medical Center-Cherry Hill, Seattle Swedish Medical Center-First Hill, Seattle PeaceHealth United General Medical Center, Sedro-Woolley Cancer Care Northwest - Spokane South, Spokane Cancer Care Northwest-North Spokane, Spokane Cancer Care Northwest-Valley, Spokane PeaceHealth Southwest Medical Center, Vancouver Providence Saint Mary Regional Cancer Center, Walla Walla |
| Wisconsin | University of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison University of Wisconsin Carbone Cancer Center - University Hospital, Madison Marshfield Medical Center-Marshfield, Marshfield Froedtert Menomonee Falls Hospital, Menomonee Falls Medical College of Wisconsin, Milwaukee ProHealth D N Greenwald Center, Mukwonago Froedtert and MCW Moorland Reserve Health Center, New Berlin Drexel Town Square Health Center, Oak Creek ProHealth Oconomowoc Memorial Hospital, Oconomowoc ProHealth Waukesha Memorial Hospital, Waukesha UW Cancer Center at ProHealth Care, Waukesha Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.