RecruitingRecruiting
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
NCT06724237 · Eastern Cooperative Oncology Group
In plain English
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Official title
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)
About this study
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
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
Study design
Enrollment target: 294 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-30
Estimated completion: 2033-12-01
Last updated: 2026-05-15
Interventions
Procedure: Autologous Hematopoietic Stem Cell TransplantationOther: Best PracticeProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyDrug: High Dose ChemotherapyProcedure: LeukapheresisProcedure: Positron Emission TomographyDrug: Stem Cell Mobilization Therapy
Primary outcomes
- • Progression-free survival (PFS) (From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years)
Sponsor
Eastern Cooperative Oncology Group · network
With: National Cancer Institute (NCI)
Contacts & investigators
ContactPamela Cogliano · contact · ecog.rss@jimmy.harvard.edu · 857-504-2900
InvestigatorNabila N Bennani · principal_investigator, ECOG-ACRIN Cancer Research Group
All locations (158)
University of Alabama at Birmingham Cancer CenterNot Yet Recruiting
Birmingham, Alabama, United States
Anchorage Associates in Radiation MedicineRecruiting
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLCRecruiting
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLCRecruiting
Anchorage, Alaska, United States
Alaska Women's Cancer CareRecruiting
Anchorage, Alaska, United States
Katmai Oncology GroupRecruiting
Anchorage, Alaska, United States
Providence Alaska Medical CenterRecruiting
Anchorage, Alaska, United States
Fairbanks Memorial HospitalActive Not Recruiting
Fairbanks, Alaska, United States
Mayo Clinic Hospital in ArizonaRecruiting
Phoenix, Arizona, United States
Banner University Medical Center - TucsonRecruiting
Tucson, Arizona, United States
University of Arizona Cancer Center-North CampusRecruiting
Tucson, Arizona, United States
Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
Burbank, California, United States
City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareRecruiting
Irvine, California, United States
Contra Costa Regional Medical CenterActive Not Recruiting
Martinez, California, United States
Providence Queen of The ValleyRecruiting
Napa, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
Orange, California, United States
Providence Medical Foundation - Santa RosaRecruiting
Santa Rosa, California, United States
Providence Santa Rosa Memorial HospitalRecruiting
Santa Rosa, California, United States
BASS Medical Group - LennonActive Not Recruiting
Walnut Creek, California, United States
Rocky Mountain Cancer Centers-AuroraActive Not Recruiting
Aurora, Colorado, United States
Boulder Community Foothills HospitalActive Not Recruiting
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-BoulderActive Not Recruiting
Boulder, Colorado, United States
Rocky Mountain Cancer Centers - CentennialActive Not Recruiting
Centennial, Colorado, United States
The Women's Imaging CenterActive Not Recruiting
Denver, Colorado, United States
Colorado Blood Cancer InstituteActive Not Recruiting
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health OneActive Not Recruiting
Denver, Colorado, United States
Rocky Mountain Cancer Centers-MidtownActive Not Recruiting
Denver, Colorado, United States
Rocky Mountain Cancer Centers-RoseActive Not Recruiting
Denver, Colorado, United States
Rocky Mountain Cancer Centers - SwedishActive Not Recruiting
Englewood, Colorado, United States
The Melanoma and Skin Cancer InstituteActive Not Recruiting
Englewood, Colorado, United States
Rocky Mountain Cancer Centers-LakewoodActive Not Recruiting
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-LittletonActive Not Recruiting
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky RidgeActive Not Recruiting
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers-LongmontActive Not Recruiting
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-ThorntonActive Not Recruiting
Thornton, Colorado, United States
Beebe Medical CenterRecruiting
Lewes, Delaware, United States
Beebe South Coastal Health CampusRecruiting
Millville, Delaware, United States
Helen F Graham Cancer CenterRecruiting
Newark, Delaware, United States
Medical Oncology Hematology Consultants PARecruiting
Newark, Delaware, United States
Christiana Care Health System-Christiana HospitalRecruiting
Newark, Delaware, United States
Beebe Health CampusRecruiting
Rehoboth Beach, Delaware, United States
Christiana Care Health System-Wilmington HospitalRecruiting
Wilmington, Delaware, United States
Mayo Clinic in FloridaRecruiting
Jacksonville, Florida, United States
Moffitt Cancer Center-International PlazaRecruiting
Tampa, Florida, United States
Moffitt Cancer Center - McKinley CampusRecruiting
Tampa, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Emory University Hospital/Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Saint Luke's Cancer Institute - BoiseRecruiting
Boise, Idaho, United States
Saint Luke's Cancer Institute - FruitlandRecruiting
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - MeridianRecruiting
Meridian, Idaho, United States
Saint Luke's Cancer Institute - NampaRecruiting
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Twin FallsRecruiting
Twin Falls, Idaho, United States
Indiana University/Melvin and Bren Simon Cancer CenterRecruiting
Indianapolis, Indiana, United States
University of Iowa/Holden Comprehensive Cancer CenterRecruiting
Iowa City, Iowa, United States
University of Kansas Cancer CenterRecruiting
Kansas City, Kansas, United States
University of Kansas Cancer Center-Overland ParkRecruiting
Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer CenterRecruiting
Westwood, Kansas, United States
The James Graham Brown Cancer Center at University of LouisvilleRecruiting
Louisville, Kentucky, United States
UofL Health Medical Center NortheastRecruiting
Louisville, Kentucky, United States
Mercy Health - Paducah Cancer CenterActive Not Recruiting
Paducah, Kentucky, United States
Ochsner Medical Center JeffersonRecruiting
New Orleans, Louisiana, United States
LSU Health Sciences Center at ShreveportRecruiting
Shreveport, Louisiana, United States
Christiana Care - Union HospitalRecruiting
Elkton, Maryland, United States
Wayne State University/Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Weisberg Cancer Treatment CenterRecruiting
Farmington Hills, Michigan, United States
Mayo Clinic in RochesterRecruiting
Rochester, Minnesota, United States
Siteman Cancer Center at Saint Peters HospitalRecruiting
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County HospitalRecruiting
Creve Coeur, Missouri, United States
University of Kansas Cancer Center - BriarcliffRecruiting
Kansas City, Missouri, United States
University of Kansas Cancer Center - NorthRecruiting
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's SummitRecruiting
Lee's Summit, Missouri, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Siteman Cancer Center-South CountyRecruiting
St Louis, Missouri, United States
Siteman Cancer Center at Christian HospitalRecruiting
St Louis, Missouri, United States
Saint Patrick Hospital - Community HospitalRecruiting
Missoula, Montana, United States
University of RochesterRecruiting
Rochester, New York, United States
UNC Lineberger Comprehensive Cancer CenterRecruiting
Chapel Hill, North Carolina, United States
Carolinas Medical Center/Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Novant Health Presbyterian Medical CenterRecruiting
Charlotte, North Carolina, United States
Wake Forest University at ClemmonsRecruiting
Clemmons, North Carolina, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
Novant Health Cancer Institute - HuntersvilleRecruiting
Huntersville, North Carolina, United States
Novant Health Presbyterian Medical Center HuntersvilleRecruiting
Huntersville, North Carolina, United States
Novant Health Cancer Institute - KernersvilleRecruiting
Kernersville, North Carolina, United States
Matthews Radiation Oncology CenterRecruiting
Matthews, North Carolina, United States
Novant Health Cancer Institute - MatthewsRecruiting
Matthews, North Carolina, United States
Novant Health Cancer Institute - MooresvilleRecruiting
Mooresville, North Carolina, United States
Novant Health Cancer Institute - Mount AiryRecruiting
Mount Airy, North Carolina, United States
Novant Health Cancer Institute - WilkesboroRecruiting
North Wilkesboro, North Carolina, United States
Rowan Regional Medical CenterRecruiting
Salisbury, North Carolina, United States
Novant Health Cancer Institute - StatesvilleRecruiting
Statesville, North Carolina, United States
Novant Health Cancer Institute - ThomasvilleRecruiting
Thomasville, North Carolina, United States
Novant Health Forsyth Medical CenterRecruiting
Winston-Salem, North Carolina, United States
Wake Forest University Health SciencesRecruiting
Winston-Salem, North Carolina, United States
OhioHealth O'Bleness HospitalRecruiting
Athens, Ohio, United States
Columbus Oncology and Hematology Associates IncRecruiting
Columbus, Ohio, United States
Riverside Methodist HospitalRecruiting
Columbus, Ohio, United States
Grant Medical CenterRecruiting
Columbus, Ohio, United States
Doctors HospitalRecruiting
Columbus, Ohio, United States
Delaware Health Center-Grady Cancer CenterRecruiting
Delaware, Ohio, United States
Grady Memorial HospitalRecruiting
Delaware, Ohio, United States
Columbus Oncology and Hematology AssociatesRecruiting
Dublin, Ohio, United States
Dublin Methodist HospitalRecruiting
Dublin, Ohio, United States
OhioHealth Mansfield HospitalRecruiting
Mansfield, Ohio, United States
OhioHealth Marion General HospitalRecruiting
Marion, Ohio, United States
OhioHealth Pickerington Methodist HospitalRecruiting
Pickerington, Ohio, United States
OhioHealth Westerville Medical Campus/Westerville Cancer CenterRecruiting
Westerville, Ohio, United States
University of Oklahoma Health Sciences CenterRecruiting
Oklahoma City, Oklahoma, United States
Saint Charles Health SystemRecruiting
Bend, Oregon, United States
Clackamas Radiation Oncology CenterRecruiting
Clackamas, Oregon, United States
Bay Area HospitalRecruiting
Coos Bay, Oregon, United States
Providence Hood River Memorial HospitalRecruiting
Hood River, Oregon, United States
Providence Newberg Medical CenterRecruiting
Newberg, Oregon, United States
Providence Willamette Falls Medical CenterRecruiting
Oregon City, Oregon, United States
Providence Portland Medical CenterRecruiting
Portland, Oregon, United States
Providence Saint Vincent Medical CenterRecruiting
Portland, Oregon, United States
Oregon Health and Science UniversityNot Yet Recruiting
Portland, Oregon, United States
Saint Charles Health System-RedmondRecruiting
Redmond, Oregon, United States
Christiana Care Health System-Concord Health CenterRecruiting
Chadds Ford, Pennsylvania, United States
Geisinger Medical CenterRecruiting
Danville, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
Wilkes-Barre, Pennsylvania, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Huntsman Cancer Institute/University of UtahRecruiting
Salt Lake City, Utah, United States
University of Virginia Cancer CenterRecruiting
Charlottesville, Virginia, United States
VCU Massey Comprehensive Cancer CenterRecruiting
Richmond, Virginia, United States
Providence Regional Cancer System-AberdeenRecruiting
Aberdeen, Washington, United States
PeaceHealth Saint Joseph Medical CenterRecruiting
Bellingham, Washington, United States
Providence Regional Cancer System-CentraliaRecruiting
Centralia, Washington, United States
Swedish Cancer Institute-EdmondsRecruiting
Edmonds, Washington, United States
Providence Regional Cancer PartnershipRecruiting
Everett, Washington, United States
Swedish Cancer Institute-IssaquahRecruiting
Issaquah, Washington, United States
Kadlec Clinic Hematology and OncologyRecruiting
Kennewick, Washington, United States
Providence Regional Cancer System-LaceyRecruiting
Lacey, Washington, United States
PeaceHealth Saint John Medical CenterRecruiting
Longview, Washington, United States
Skagit Regional Health Cancer Care CenterRecruiting
Mount Vernon, Washington, United States
Jefferson HealthcareActive Not Recruiting
Port Townsend, Washington, United States
Swedish Medical Center-Ballard CampusRecruiting
Seattle, Washington, United States
Swedish Medical Center-Cherry HillRecruiting
Seattle, Washington, United States
Swedish Medical Center-First HillRecruiting
Seattle, Washington, United States
PeaceHealth United General Medical CenterRecruiting
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane SouthRecruiting
Spokane, Washington, United States
Cancer Care Northwest-ValleyRecruiting
Spokane, Washington, United States
Cancer Care Northwest-North SpokaneRecruiting
Spokane, Washington, United States
PeaceHealth Southwest Medical CenterRecruiting
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer CenterRecruiting
Walla Walla, Washington, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterRecruiting
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University HospitalRecruiting
Madison, Wisconsin, United States
Marshfield Medical Center-MarshfieldRecruiting
Marshfield, Wisconsin, United States
Froedtert Menomonee Falls HospitalRecruiting
Menomonee Falls, Wisconsin, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
ProHealth D N Greenwald CenterRecruiting
Mukwonago, Wisconsin, United States
Froedtert and MCW Moorland Reserve Health CenterRecruiting
New Berlin, Wisconsin, United States
Drexel Town Square Health CenterRecruiting
Oak Creek, Wisconsin, United States
ProHealth Oconomowoc Memorial HospitalRecruiting
Oconomowoc, Wisconsin, United States
ProHealth Waukesha Memorial HospitalRecruiting
Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth CareRecruiting
Waukesha, Wisconsin, United States
Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
West Bend, Wisconsin, United States