Actively Recruiting
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
Led by Eastern Cooperative Oncology Group · Updated on 2026-05-05
294
Participants Needed
1
Research Sites
461 weeks
Total Duration
On this page
Sponsors
E
Eastern Cooperative Oncology Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 to 75 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Diagnosis of one of the following peripheral T-cell lymphoma types: ALK-negative anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, nodal PTCL with follicular helper T cell phenotype, or PTCL not otherwise specified
- Completed induction therapy with anthracycline-based chemotherapy and achieved radiologic complete remission by Lugano criteria with Deauville score 1-3 on PET-CT
- Eligibility for high dose chemotherapy and autologous stem cell transplant according to institutional guidelines
- No active infection requiring intravenous systemic antimicrobial treatment at randomization; stable antibiotic prophylaxis allowed
- Patients with prior or concurrent malignancies that do not interfere with study treatment assessment
- Negative pregnancy test within 14 days prior to randomization for patients of childbearing potential
- Agreement to use effective contraception or abstain from conception during and after treatment phase
- Absolute neutrophil count ≥ 1000/mcL within 14 days prior to randomization
- Platelet count ≥ 75,000/mcL within 14 days prior to randomization
- Total bilirubin ≤ 1.5 times institutional upper limit of normal within 14 days prior to randomization
- AST/ALT ≤ 3.0 times institutional upper limit of normal within 14 days prior to randomization
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to randomization
- Patients with chronic hepatitis B infection must have undetectable viral load on suppressive therapy if indicated
- Patients with hepatitis C infection must have been treated and cured or have undetectable viral load if currently on treatment
You will not qualify if you...
- Active infection requiring intravenous systemic antimicrobial therapy at randomization
- Pregnant or breastfeeding women
- Patients not eligible for high dose chemotherapy and autologous stem cell transplant per institutional guidelines
- Patients who have not achieved complete remission following induction chemotherapy
- Patients outside the age range of 18 to 75 years
- Patients with uncontrolled or interfering prior or concurrent malignancies that affect safety or efficacy assessment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States, 99508
Actively Recruiting
Research Team
P
Pamela Cogliano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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