NCT06915246 A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
| NCT ID | NCT06915246 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VIVUS LLC |
| Condition | Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 49 participants |
| Start Date | 2025-03-12 |
| Primary Completion | 2027-03-31 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 49 participants in total. It began in 2025-03-12 with a primary completion date of 2027-03-31.
⚠ 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
A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
Eligibility Criteria
Inclusion Criteria: * Male and female adults ≥ 18 years of age with a life expectancy ≥ 6 months; * Karnofsky performance status ≥ 70%; * Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma; * Candidate for AHCT consolidation therapy as assessed by their treating physician; * Achieved a complete or partial response; * Completed collection of at least 2.0 x 10\^6 CD34 cells/kg of autologous hematopoietic progenitor cells (HPCs) by apheresis; * Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to ≤ grade 2; * Clinical laboratory and organ function criteria meeting study ranges/limits LVEF ≥ 50%; FEV1 \> 65% of predicted measurement, DLCO ≥ 50% of predicted; * Seronegative for HIV Ag/Ab combo, HCV, active HBV, and syphilis Exclusion Criteria: * Prior high-dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation; * Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records; * Use of any other investigational medication or device, or concurrent biological, chemotherapy, or radiation therapy; * Myelodysplasia or any active malignancy other than HL or NHL, or \< 5 years remission from any other prior malignancy; * Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia; * Persistent marrow involvement (\>10%) with HL or NHL after salvage cytoreductive therapy and before stem cell mobilization; * Not having sufficient bone marrow harvest to reach adequate cell dose for transplant; * Active hepatitis B or C viral infection or HBsAg positive; * Positive HIV antibody;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06915246 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma. 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 NCT06915246 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06915246 currently recruiting?
Yes, NCT06915246 is actively recruiting participants. Contact the research team at clinical@vivus.com for enrollment information.
Where is the NCT06915246 trial being conducted?
This trial is being conducted at Goodyear, United States, Duarte, United States, Newnan, United States, Zion, United States.
Who is sponsoring the NCT06915246 clinical trial?
NCT06915246 is sponsored by VIVUS LLC. The trial plans to enroll 49 participants.