Hodgkin Lymphoma, Non Hodgkin Lymphoma
Conditions
Keywords
Lymphoma, Cellular Therapy
Brief summary
High-dose chemotherapy followed by blood stem cell transplantation is administered to lymphoma patients with an intention to cure. However, high-dose chemotherapy simultaneously causes damage to healthy tissues that frequently result in severe complications that lead to hospitalization and can be life threatening. These severe complications involve the blood, immune, gastro-intestinal systems, and other vital organs. The purpose of this study is to determine if experimental therapy AB-205 (study drug) can prevent or reduce the occurrence and duration of the severe chemotherapy related complications when compared to placebo in patients with lymphoma undergoing treatment with high-dose chemotherapy and blood stem cell transplantation. All patients, whether treated with AB-205 or placebo, will receive standard preventive and supportive care therapies.
Interventions
BIOLOGICALAB-205
Allogeneic genetically engineered human umbilical vein endothelial cells
OTHERPlacebo
Placebo
Sponsors
California Institute for Regenerative Medicine (CIRM)
Angiocrine Bioscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 40 years old 2. Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) 3. Candidates for HDT-AHCT with one of the following conditioning regimens: 1. BEAM (carmustine, etoposide, cytarabine, melphalan) 2. BeEAM (bendamustine, etoposide, cytarabine, melphalan) 4. Achieved CR or PR prior to planned HDT 5. ECOG ≤ 2 6. Weight ≤ 1.6 × ideal body weight (IBW) per Devine formula 7. Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia 8. AST, ALT, and alkaline phosphatase \< 3 × ULN 9. Creatinine clearance ≥ 30 ml/min (calculated by Cockcroft Gault) 10. LVEF ≥ 45% by MUGA or resting echocardiogram 11. Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted 12. Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions 13. Sexually active females of childbearing potential must have a negative urine pregnancy test and agree to use two accepted methods of contraception during the study and for 3 months after their last dose of study drug. 14. Male subjects who are sexually active and who are partners of females of childbearing potential: agreement to use two forms of contraception as in criterion 12 above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug 15. Ability to provide written informed consent.
Exclusion criteria
1. History of prior HCT 2. Primary CNS lymphoma 3. Lymphoma with CNS involvement at time of relapse prior to planned HDT-AHCT 4. Active malignancy other than the one for which the subject is undergoing HDT AHCT. Subjects with cervical carcinoma in situ or localized basal or squamous cell carcinoma treated with definitive surgery are eligible 5. Subjects with a serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics 6. Subjects with a known history of HIV 7. Subjects who have known hypersensitivity reactions to bovine (cow) proteins or documented allergy to DMSO 8. Subject has other conditions that in the opinion of the investigator would require reduced dose (intensity) of BEAM or BeEAM regimens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absence of oral/GI severe regimen related toxicities (oral/GI SRRT). | 21 Days |
Secondary
| Measure | Time frame |
|---|---|
| Duration of oral/GI SRRT | 21 Days |
| Symptom burden per MD Anderson Symptom Inventory (MDASI) | 21 Days |
| Duration of febrile neutropenia | 21 Days |
| Time to neutrophil engraftment | 21 Days |
Countries
United States
Outcome results
None listed