A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
NCT ID: NCT06915246
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
49 participants
INTERVENTIONAL
2025-03-12
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VI-0609
VI-0609 (Carmustine with Propylene Glycol)
VI-0609
Carmustine with Propylene Glycol
BiCNU
BiCNU (Carmustine with Ethanol)
BiCNU
Carmustine with Ethanol
Interventions
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VI-0609
Carmustine with Propylene Glycol
BiCNU
Carmustine with Ethanol
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
ALL
No
Sponsors
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VIVUS LLC
INDUSTRY
Responsible Party
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Locations
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City of Hope Phoenix
Goodyear, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
City of Hope Atlanta
Newnan, Georgia, United States
City of Hope Chicago
Zion, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LY-201
Identifier Type: -
Identifier Source: org_study_id
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