A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;
Primary outcome measure(s)
Evaluation of infusion-related toxicities — Within 24 hours post infusion
Evaluation of unacceptable toxicities — From start of BEAM through Day 30 post-AHCT
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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