A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
Recruiting now · Phase 2
Conditions studied: Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma
In brief
A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
Key facts
- Study ID
- NCT06915246
- Run by
- VIVUS LLC
- People needed
- 49
- Starts
- 2025-03-12
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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;
Where it is running
- City of Hope Phoenix — Goodyear, Arizona, United States (enrolling)
- City of Hope National Medical Center — Duarte, California, United States (enrolling)
- City of Hope Atlanta — Newnan, Georgia, United States (enrolling)
- City of Hope Chicago — Zion, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.