NCT06724237 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
| NCT ID | NCT06724237 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Eastern Cooperative Oncology Group |
| Condition | Anaplastic Large Cell Lymphoma, ALK-Negative |
| Study Type | INTERVENTIONAL |
| Enrollment | 294 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 294 participants in total. It began in 2025-01-30 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patient must be 18 to 75 years of age * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * 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 follicular helper T cell (TFH) phenotype * Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) * 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 * Patient must have achieved radiologic complete remission following induction therapy as defined by the Lugano criteria with a Deauville score between 1-3 by PET-CT * NOTE: There is no central review required. Confirmation of complete remission status is determined by the enrolling institution's review * NOTE: If a patient had a positive bone marrow biopsy at the time of initial diagnosis (pre-induction), a repeat biopsy must be completed post induction to confirm complete remission (CR) * Patient must be eligible for high dose chemotherapy and autologous stem cell transplant (ASCT) per the enrolling institutional guidelines at the transplant center and be ready to proceed with ASCT if randomized to the ASCT arm * Patient must not have active infection requiring intravenous systemic antimicrobial at time of randomization. Antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7 days prior to randomization * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse during the treatment phase of the study and thereafter according to institutional guidelines * Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to protocol randomization) * Platelets ≥ 75,000/mcL (obtained ≤ 14 days prior to protocol randomization) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x institutional ULN (obtained ≤ 14 days prior to protocol randomization) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Contact & Investigator
Nabila N Bennani
PRINCIPAL INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Frequently Asked Questions
Who can join the NCT06724237 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Anaplastic Large Cell Lymphoma, ALK-Negative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06724237 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 294 participants.
Is NCT06724237 currently recruiting?
Yes, NCT06724237 is actively recruiting participants. Contact the research team at ecog.rss@jimmy.harvard.edu for enrollment information.
Where is the NCT06724237 trial being conducted?
This trial is being conducted at Birmingham, United States, Anchorage, United States, Anchorage, United States, Anchorage, United States and 11 additional locations.
Who is sponsoring the NCT06724237 clinical trial?
NCT06724237 is sponsored by Eastern Cooperative Oncology Group. The principal investigator is Nabila N Bennani at ECOG-ACRIN Cancer Research Group. The trial plans to enroll 294 participants.