Carmustine treatment for lymphoma patients

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)

This study is testing if adding a new drug called VI-0609 to a standard treatment helps lymphoma patients do better after a stem cell transplant.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VIVUS LLC (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 4 sites (Goodyear, Arizona and 3 other locations)
• Trial ID: NCT06915246 on ClinicalTrials.gov

What this trial studies

This phase 2 multicenter study evaluates the effectiveness of VI-0609 compared to BiCNU as part of the BEAM high-intensity conditioning regimen for autologous hematopoietic cell transplantation (AHCT) in patients with Hodgkin and Non-Hodgkin lymphoma. Participants must have achieved a complete or partial response to prior treatments and meet specific health criteria. The study aims to determine if the addition of VI-0609 improves outcomes for lymphoma patients undergoing AHCT.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed Hodgkin or Non-Hodgkin lymphoma who are eligible for AHCT.

Not a fit: Patients who have previously undergone high-dose chemotherapy with autologous stem cell transplant or allogeneic transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for lymphoma patients undergoing stem cell transplantation.

How similar studies have performed: Other studies have shown promise with similar high-intensity conditioning regimens, but the specific combination of VI-0609 and BiCNU is being evaluated for the first time.

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;

Where this trial is running

Goodyear, Arizona and 3 other locations

• City of Hope Phoenix — Goodyear, Arizona, United States (RECRUITING)
• City of Hope National Medical Center — Duarte, California, United States (RECRUITING)
• City of Hope Atlanta — Newnan, Georgia, United States (RECRUITING)
• City of Hope Chicago — Zion, Illinois, United States (RECRUITING)

Study contacts

• Study coordinator: VIVUS Clinical

Conditions: Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, AHCT, BiCNU, Carmustine