Health TrialsbyHealthPanel

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

ConditionsAnaplastic Large Cell Lymphoma, ALK-NegativeFollicular Helper T-Cell LymphomaFollicular Helper T-Cell Lymphoma, Angioimmunoblastic-TypePeripheral T-Cell Lymphoma, Not Otherwise Specified
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEastern Cooperative Oncology Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must be 18 to 75 years of age

Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Anaplastic large cell lymphoma (ALCL) ALK-negative

Angioimmunoblastic T-cell lymphoma (AITL)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autologous Hematopoietic Stem Cell Transplantation

    Procedure/Surgery

    Undergo ASCT

  • Best Practice

    Other intervention

    Receive standard of care observation

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • High Dose Chemotherapy

    Drug

    Receive high dose chemotherapy

  • Leukapheresis

    Procedure/Surgery

    Undergo leukapheresis

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Stem Cell Mobilization Therapy

    Drug

    Receive stem cell mobilization therapy

Treatment groups

294 Participants
are divided into 2 treatment groups
Group A: Arm I (observation)Active comparator 6 interventions
Group B: Arm II (high dose chemotherapy and ASCT)Experimental treatment 9 interventions

Trial outcomes

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.

Time frame
From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years

Secondary outcomes

1

Overall survival (OS)

Stratified logrank test will be used for the primary analysis of the comparison of OS 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.

Time frame
From study randomization to death due to any cause, assessed up to 12 years
2

Cumulative incidence of relapse

The cumulative incidence of relapse will be analyzed under the competing risk framework using competing risk regression and competing risk cumulative incidence function plots.

Time frame
Up to 12 years
3

Cumulative incidence of mortality

The cumulative incidence of mortality will be analyzed under the competing risk framework using competing risk regression and competing risk cumulative incidence function plots.

Time frame
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

The proportion of patients with MRD negative results after ASCT will be reported among arm B patients. MRD negative is defined as no lymphoma cell detected.

Time frame
Up to 12 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eastern Cooperative Oncology Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now