Study on Carmustine With and Without Ethanol for Lymphoma Patients

Sponsor: VIVUS LLC

Sponsor score: 0

ClinicalTrials ID:NCT06915246

This clinical trial is comparing two treatments, one with Carmustine and another with a combination of Carmustine and Ethanol, to see which is more effective for patients with lymphoma undergoing high-intensity conditioning before a stem cell transplant.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of two different treatments, one using Carmustine alone and the other using Carmustine with Ethanol, in patients with lymphoma who are preparing for a high-intensity conditioning regimen before an autologous hematopoietic stem cell transplant (AHCT).

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a life expectancy of at least 6 months.
  • Have a Karnofsky performance status of 70% or higher, indicating they can care for themselves with some assistance.
  • Diagnosed with Hodgkin or Non-Hodgkin lymphoma.
  • Suitable for AHCT consolidation therapy as determined by their doctor.
  • Have achieved either a complete or partial response to previous treatment.
  • Have collected enough stem cells for transplant through a process called apheresis.
  • Have recovered from previous chemotherapy side effects to a mild level (grade 2 or less).
  • Meet specific lab and organ function criteria, including heart and lung function tests.
  • Test negative for HIV, hepatitis C, active hepatitis B, and syphilis.

Exclusion Criteria

  • Have had previous high-dose chemotherapy with a stem cell transplant or an allogeneic transplant.
  • Have received significant radiation to a critical organ that limits further treatment.
  • Are using any other investigational drugs or devices, or receiving other cancer treatments.
  • Have myelodysplasia or another active cancer, unless in remission for at least 5 years.
  • Have certain genetic abnormalities in the bone marrow linked to myelodysplasia.
  • Have more than 10% bone marrow involvement with lymphoma after previous therapy.
  • Do not have enough stem cells collected for transplant.
  • Have active hepatitis B or C infection, or test positive for hepatitis B surface antigen.
  • Test positive for HIV antibodies.

Locations

FACILITYZIPCITYSTATE
City of Hope Phoenix85338GoodyearArizona
City of Hope National Medical Center91010DuarteCalifornia
City of Hope Atlanta30265NewnanGeorgia
City of Hope Chicago60099ZionIllinois

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