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)

VIVUS LLC

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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 crit…

Interventions

Drug
VI-0609
Carmustine with Propylene Glycol
Drug
BiCNU
Carmustine with Ethanol

Locations (4)

City of Hope Phoenix
Goodyear, Arizona
akeryan@coh.org 626-218-1124
City of Hope National Medical Center
Duarte, California
akeryan@coh.org 626-218-1124
City of Hope Atlanta
Newnan, Georgia
akeryan@coh.org 626-218-1124
City of Hope Chicago
Zion, Illinois
akeryan@coh.org 626-218-1124

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)

Summary

Eligibility

Interventions

Locations (4)

Compensation

Run this study?

Details

Conditions