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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

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.

AlabamaUniversity of Alabama at Birmingham Cancer Center, Birmingham (Not yet recruiting)
AlaskaAlaska 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
ArizonaMayo Clinic Hospital in Arizona, Phoenix
Banner University Medical Center - Tucson, Tucson
University of Arizona Cancer Center-North Campus, Tucson
CaliforniaProvidence 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
DelawareBeebe 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 ColumbiaSibley Memorial Hospital, Washington D.C.
FloridaMayo Clinic in Florida, Jacksonville
Moffitt Cancer Center, Tampa
Moffitt Cancer Center - McKinley Campus, Tampa
Moffitt Cancer Center-International Plaza, Tampa
GeorgiaEmory University Hospital/Winship Cancer Institute, Atlanta
IdahoSaint 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
IllinoisLoyola 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
IndianaIndiana University/Melvin and Bren Simon Cancer Center, Indianapolis
IowaUniversity of Iowa/Holden Comprehensive Cancer Center, Iowa City
KansasUniversity of Kansas Cancer Center, Kansas City
University of Kansas Cancer Center-Overland Park, Overland Park
University of Kansas Hospital-Westwood Cancer Center, Westwood
KentuckyThe James Graham Brown Cancer Center at University of Louisville, Louisville
UofL Health Medical Center Northeast, Louisville
LouisianaOchsner Medical Center Jefferson, New Orleans
LSU Health Sciences Center at Shreveport, Shreveport
MarylandJohns Hopkins University/Sidney Kimmel Cancer Center, Baltimore
Christiana Care - Union Hospital, Elkton
MichiganWayne State University/Karmanos Cancer Institute, Detroit
Weisberg Cancer Treatment Center, Farmington Hills
MinnesotaMayo Clinic in Rochester, Rochester
MissouriSiteman 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
MontanaSaint Patrick Hospital - Community Hospital, Missoula
New YorkUniversity of Rochester, Rochester
North CarolinaUNC 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
OhioOhioHealth 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
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
OregonSaint 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
PennsylvaniaChristiana Care Health System-Concord Health Center, Chadds Ford
Geisinger Medical Center, Danville
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
South CarolinaMedical University of South Carolina, Charleston
UtahHuntsman Cancer Institute/University of Utah, Salt Lake City
VirginiaUniversity of Virginia Cancer Center, Charlottesville
VCU Massey Comprehensive Cancer Center, Richmond
WashingtonProvidence 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
WisconsinUniversity 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.