Recruiting NCT06915246
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VI-0609, BiCNU.
- Who it may be relevant to
- Registry conditions: Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
Interventions
- Drug VI-0609
Carmustine with Propylene Glycol - Drug BiCNU
Carmustine with Ethanol
Primary outcome measures
- Evaluation of infusion-related toxicities [Time frame: Within 24 hours post infusion]
- Evaluation of unacceptable toxicities [Time frame: From start of BEAM through Day 30 post-AHCT]
Eligibility 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- City of Hope Phoenix — Goodyear
- City of Hope National Medical Center — Duarte
- City of Hope Atlanta — Newnan
- City of Hope Chicago — Zion
Identifiers
NCT: NCT06915246 · LY-201