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

Description

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

Conditions

Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation

Study Overview

Study Details

Study overview

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

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)

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

Condition
Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
Intervention / Treatment

-

Contacts and Locations

Goodyear

City of Hope Phoenix, Goodyear, Arizona, United States, 85338

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Newnan

City of Hope Atlanta, Newnan, Georgia, United States, 30265

Zion

City of Hope Chicago, Zion, Illinois, United States, 60099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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;

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VIVUS LLC,

Study Record Dates

2026-04-30