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

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

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo ASCT

OTHER

Best Practice

Receive standard of care observation

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

DRUG

High Dose Chemotherapy

Receive high dose chemotherapy

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

DRUG

Stem Cell Mobilization Therapy

Receive stem cell mobilization therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Eastern Cooperative Oncology Group

  lead NETWORK

Principal Investigators

• Nabila N Bennani · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-30

Primary Completion

2028-04-30

Completion

2033-12-01

FDA Drug

Yes

Countries

• United States

Study Locations