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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
  Undergo ASCT
• Best Practice — OTHER
  Receive standard of care observation
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Computed Tomography — PROCEDURE
  Undergo CT or PET/CT
• High Dose Chemotherapy — DRUG
  Receive high dose chemotherapy
• Leukapheresis — PROCEDURE
  Undergo leukapheresis
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Stem Cell Mobilization Therapy — DRUG
  Receive stem cell mobilization therapy

Study Details

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.

Key Dates

Start date

Jan 30, 2025

Status verified

Apr 2026

Primary completion

Apr 30, 2028

Completion

Dec 1, 2033

Study Design

Enrollment

294 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (observation)
  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.
• Experimental: Arm II (high dose chemotherapy and ASCT)
  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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years ]

Central Contacts

• Pamela Cogliano
  857-504-2900
  [email protected]

Locations (158)

Find similar trials in Birmingham, AL

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