Status:
RECRUITING
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
Lead Sponsor:
VIVUS LLC
Conditions:
Lymphoma
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- 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;
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06915246
Start Date
March 12 2025
End Date
April 30 2026
Last Update
April 10 2025
Active Locations (4)
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1
City of Hope Phoenix
Goodyear, Arizona, United States, 85338
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
City of Hope Atlanta
Newnan, Georgia, United States, 30265
4
City of Hope Chicago
Zion, Illinois, United States, 60099