NCT06915246PHASE2Recruiting
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
VIVUS LLC
Start Date
3/12/2025
Completion Date
4/30/2027
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
Age Range: 18 years to No maximum
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;
Interventions
DRUG
VI-0609
DRUG
BiCNU
Conditions
LymphomaNon-Hodgkin LymphomaHodgkin Lymphoma
Locations
City of Hope Phoenix
Goodyear, Arizona 85338
United States
City of Hope National Medical Center
Duarte, California 91010
United States
City of Hope Atlanta
Newnan, Georgia 30265
United States
City of Hope Chicago
Zion, Illinois 60099
United States