RECRUITING

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

Conditions

Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation Lymphoma AHCT BiCNU Carmustine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2025-03-12

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06915246

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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;

Inclusion Criteria

Exclusion 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;

Contacts and Locations

Study Contact

VIVUS Clinical

CONTACT

+1-888-998-4887

clinical@vivus.com

Study Locations (Sites)

City of Hope Phoenix

Goodyear, Arizona, 85338

United States

City of Hope National Medical Center

Duarte, California, 91010

United States

City of Hope Atlanta

Newnan, Georgia, 30265

United States

City of Hope Chicago

Zion, Illinois, 60099

United States

Collaborators and Investigators

Sponsor: VIVUS LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-12

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2025-03-12

Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

Lymphoma
AHCT
BiCNU
Carmustine

Additional Relevant MeSH Terms

Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation