Hodgkin Lymphoma, Lymphoma, Non-Hodgkin Lymphoma
Conditions
Keywords
Lymphoma, AHCT, BiCNU, Carmustine
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.
Interventions
DRUGVI-0609
Carmustine with Propylene Glycol
DRUGBiCNU
Carmustine with Ethanol
Sponsors
VIVUS LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of infusion-related toxicities | Within 24 hours post infusion |
| Evaluation of unacceptable toxicities | From start of BEAM through Day 30 post-AHCT |
Countries
United States
Contacts
CONTACTVIVUS Clinical
Outcome results
None listed