Carmustine treatment for lymphoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 multicenter study evaluates the effectiveness of VI-0609 compared to BiCNU as part of the BEAM high-intensity conditioning regimen for autologous hematopoietic cell transplantation (AHCT) in patients with Hodgkin and Non-Hodgkin lymphoma. Participants must have achieved a complete or partial response to prior treatments and meet specific health criteria. The study aims to determine if the addition of VI-0609 improves outcomes for lymphoma patients undergoing AHCT.

Why it matters

Who can join: the full rules

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;

Where it's running

• City of Hope Phoenix
  Goodyear, Arizona, United States Recruiting
• City of Hope National Medical Center
  Duarte, California, United States Recruiting
• City of Hope Atlanta
  Newnan, Georgia, United States Recruiting
• City of Hope Chicago
  Zion, Illinois, United States Recruiting

Study contacts

• Study coordinator: VIVUS Clinical
• Email: clinical@vivus.com
• Phone: +1-888-998-4887

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.