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)

U
Utpal Dave, MD

Primary Investigator

Recruiting
18 years - 75 years
All
Phase 3
5 participants needed
1 Location

Brief description of study

Primary: To demonstrate improvement in progression free survival (PFS) in the autologous stem cell transplant (ASCT) arm compared to the observation arm. Secondary: -To assess difference in overall survival (OS) between the observation and autologous stem cell transplant (ASCT) arm. -To evaluate the differences in study intervention benefit for PFS and OS by the randomization stratification factors (histology and choice of induction chemotherapy). To evaluate the cumulative incidence of relapse and mortality between the observational and autologous stem cell transplant (ASCT) arm.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

Prior to enrollment, patients must have already completed induction with an anthracycline based chemotherapy regimen and be in complete remission (CR). Patients will then be randomized to either the Observation arm (Arm A) or the Autologous Stem Cell Transplant arm (Arm B).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Peripheral T Cell Lymphoma, Cancer
  • Age: 18 years - 75 years
  • Gender: All

Eligibility Criteria
3.1.1 Patient must be 18 to 75 years of age.
3.1.2 Patient must have an ECOG Performance Status 0-2.
3.1.3 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 TFH phenotype
• peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
3.1.4 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 

Updated on 21 Oct 2025. Study ID: CTO-EA4232, 27404

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