RecruitingPhase 2NCT06915246
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
A Randomized Phase 2 Study of Carmustine Formulated With and Without Ethanol as Part of BEAM Chemotherapy Conditioning for Subjects With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (AHCT)
Sponsor
VIVUS LLC
Enrollment
49 participants
Start Date
Mar 12, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria9
- 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 Criteria9
- 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
DRUGVI-0609
Carmustine with Propylene Glycol
DRUGBiCNU
Carmustine with Ethanol
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06915246
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