Clinical trial NCT06915246: A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lymphoma
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Keywords: Lymphoma
AHCT
BiCNU
Carmustine
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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;

Primary outcomes:
measure: Evaluation of infusion-related toxicities
timeFrame: Within 24 hours post infusion
measure: Evaluation of unacceptable toxicities
timeFrame: From start of BEAM through Day 30 post-AHCT
Secondary outcomes:
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: City of Hope Phoenix
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Newnan
country: United States
facility: City of Hope Atlanta
state: Georgia
city: Zion
country: United States
facility: City of Hope Chicago
state: Illinois
Study officials:
References: