A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma

Vivus

Status and phase: Enrolling; Phase 2

Conditions: Hodgkin Lymphoma; Lymphoma; Non-Hodgkin Lymphoma

Treatments: Drug: BiCNU; Drug: VI-0609

Study type: Interventional

Funder types: Industry

Identifiers

NCT06915246

LY-201

Details and patient eligibility

About

A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.

Enrollment: 49 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

VI-0609

Experimental group

Description:

VI-0609 (Carmustine with Propylene Glycol)

Treatment:

Drug: VI-0609

BiCNU

Active Comparator group

Description:

BiCNU (Carmustine with Ethanol)

Treatment:

Drug: BiCNU