NCT06724237|RecruitingPhase 3FDA Drug

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

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)

Eastern Cooperative Oncology Group ClinicalTrials.gov

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3 other identifiers

EA4232NCI-2024-06604U10CA180820

Study Type

interventional

Target

294

Locations

1 country

Sites

158

Timeline

RegisteredDec 2024

StartedJan 2025

CompletionDec 2033

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

294

participants targeted

Target at P50-P75 for phase_3

Timeline

90mo left

Started Jan 2025

Longer than P75 for phase_3

Geographic Reach

1 country

158 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.8 years study duration

Study Progress17%

Jan 2025Dec 2033

First Submitted

Initial submission to the registry

November 5, 2024

Completed

1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected

5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2033

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

3.2 years

First QC Date

November 5, 2024

Last Update Submit

July 16, 2026

Conditions

Follicular Helper T-Cell Lymphoma Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type Peripheral T-Cell Lymphoma, Not Otherwise Specified Anaplastic Large Cell Lymphoma, ALK-Negative

Outcome Measures

Primary Outcomes (1)

Progression-free survival (PFS)
Stratified logrank test will be used for the primary analysis of the comparison of PFS between treatment arms. Kaplan-Meier method will be used to visualize and estimate survival function for failure time endpoints. There will be a subgroup analysis for the randomization stratification factors, and other variables measured at baseline.
From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years

Secondary Outcomes (3)

Overall survival (OS)
From study randomization to death due to any cause, assessed up to 12 years
Cumulative incidence of relapse
Up to 12 years
Cumulative incidence of mortality
Up to 12 years

Other Outcomes (1)

Proportion of patients with minimal residual disease (MRD) negative result after autologous stem cell transplant (ASCT) in arm B
Up to 12 years

Study Arms (2)

Arm I (observation)

ACTIVE COMPARATOR

Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.

Other: Best PracticeProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyProcedure: Positron Emission Tomography

Arm II (high dose chemotherapy and ASCT)

EXPERIMENTAL

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.

Procedure: Autologous Hematopoietic Stem Cell TransplantationProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyDrug: High Dose ChemotherapyProcedure: LeukapheresisProcedure: Positron Emission TomographyDrug: Stem Cell Mobilization Therapy

Interventions

Autologous Hematopoietic Stem Cell TransplantationPROCEDURE

Undergo ASCT

Also known as: AHSCT, Autologous, Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplant, Autologous Stem Cell Transplantation, Stem Cell Transplantation, Autologous

Arm II (high dose chemotherapy and ASCT)

Best PracticeOTHER

Receive standard of care observation

Also known as: standard of care, standard therapy

Arm I (observation)

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (observation)Arm II (high dose chemotherapy and ASCT)

Bone Marrow AspirationPROCEDURE

Undergo bone marrow aspiration and biopsy

Arm I (observation)Arm II (high dose chemotherapy and ASCT)

Bone Marrow BiopsyPROCEDURE

Undergo bone marrow aspiration and biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Arm I (observation)Arm II (high dose chemotherapy and ASCT)

Computed TomographyPROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Arm I (observation)Arm II (high dose chemotherapy and ASCT)

High Dose ChemotherapyDRUG

Receive high dose chemotherapy

Also known as: high-dose chemotherapy

Arm II (high dose chemotherapy and ASCT)

LeukapheresisPROCEDURE

Undergo leukapheresis

Also known as: Leukocyte Adsorptive Apheresis, Leukocytopheresis, Therapeutic Leukopheresis, White Blood Cell Reduction Apheresis

Arm II (high dose chemotherapy and ASCT)

Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Arm I (observation)Arm II (high dose chemotherapy and ASCT)

Stem Cell Mobilization TherapyDRUG

Receive stem cell mobilization therapy

Also known as: Chemomobilization, Hematopoietic Stem Cell Mobilization, Mobilization Therapy, Stem-cell mobilization

Arm II (high dose chemotherapy and ASCT)

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eastern Cooperative Oncology Grouplead
National Cancer Institute (NCI)collaborator

Study Sites (158)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

RECRUITING

Alaska Breast Care and Surgery LLC