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Clinical Trials in the USA / NCT06915246
Recruiting Phase 2

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

NCT06915246 · tracked via the Priya Life Science USA tracker
Sponsor
VIVUS LLC
Phase
Phase 2
Started
2025-03-12
Last updated
2026-03-27

Condition(s) studied

LymphomaNon-Hodgkin LymphomaHodgkin Lymphoma

Investigational drug(s) / intervention(s)

VI-0609BiCNU

VI-0609: Carmustine with Propylene Glycol

BiCNU: Carmustine with Ethanol

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
City of Hope Phoenix Goodyear Arizona Recruiting
City of Hope National Medical Center Duarte California Recruiting
City of Hope Atlanta Newnan Georgia Recruiting
City of Hope Chicago Zion Illinois Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06915246 on ClinicalTrials.gov ↗ ← All trials in the USA