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

Status
Active
Cancer Type
Hodgkin Lymphoma
Lymphoma
Non-Hodgkin Lymphoma
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06915246
Protocol IDs
LY-201 (primary)
NCI-2025-02742
Study Sponsor
VIVUS Inc

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

  1. Male and female adults = 18 years of age with a life expectancy = 6 months;
  2. Karnofsky performance status = 70%;
  3. Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma;
  4. Candidate for AHCT consolidation therapy as assessed by their treating physician;
  5. Achieved a complete or partial response;
  6. Completed collection of at least 2.0 x 10^6 CD34 cells/kg of autologous hematopoietic progenitor cells (HPCs) by apheresis;
  7. Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to = grade 2;
  8. Clinical laboratory and organ function criteria meeting study ranges/limits LVEF = 50%; FEV1 > 65% of predicted measurement, DLCO = 50% of predicted;
  9. Seronegative for HIV Ag/Ab combo, HCV, active HBV, and syphilis

Treatment Sites in Georgia

City of Hope Atlanta


600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.