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 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: EA4232NCI-2024-06604U10CA180820
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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 Practice; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Procedure: 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 Transplantation; 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

Interventions

Autologous Hematopoietic Stem Cell Transplantation PROCEDURE

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 Practice OTHER

Receive standard of care observation

Also known as: standard of care, standard therapy

Arm I (observation)

Biospecimen Collection PROCEDURE

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 Aspiration PROCEDURE

Undergo bone marrow aspiration and biopsy

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

Bone Marrow Biopsy PROCEDURE

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 Tomography PROCEDURE

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 Chemotherapy DRUG

Receive high dose chemotherapy

Also known as: high-dose chemotherapy

Arm II (high dose chemotherapy and ASCT)

Leukapheresis PROCEDURE

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 Tomography PROCEDURE

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 Therapy DRUG

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

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, 99508, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic; Lymphoma, T-Cell

Interventions

Stem Cell Transplantation; Practice Guidelines as Topic; Standard of Care; Specimen Handling; Biopsy; Drug Therapy; Leukapheresis; Magnetic Resonance Spectroscopy; Hematopoietic Stem Cell Mobilization

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Cytapheresis; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Nabila N Bennani

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Cogliano

CONTACT

857-504-2900; ecog.rss@jimmy.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: December 9, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)