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NCT06915246 | RECRUITING | Lymphoma

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

Living LLC

Brief Summary:

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

Condition or disease

Lymphoma

Non-Hodgkin Lymphoma

Hodgkin Lymphoma

Intervention/treatment

VI-0609

BiCNU

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 49 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2025-03-12
Estimated Primary Completion Date : 2026-03-31
Estimated Study Completion Date : 2026-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 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
Exclusion Criteria
  • * 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;
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma

Location Details

NCT06915246

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How to Participate

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Locations

RECRUITING

United States, Arizona

City of Hope Phoenix

Goodyear, Arizona, United States, 85338

RECRUITING

United States, California

City of Hope National Medical Center

Duarte, California, United States, 91010

RECRUITING

United States, Georgia

City of Hope Atlanta

Newnan, Georgia, United States, 30265

RECRUITING

United States, Illinois

City of Hope Chicago

Zion, Illinois, United States, 60099