Status:
TERMINATED
A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
Lead Sponsor:
Angiocrine Bioscience
Collaborating Sponsors:
California Institute for Regenerative Medicine (CIRM)
Conditions:
Hodgkin Lymphoma
Non Hodgkin Lymphoma
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 healt...
Eligibility Criteria
Inclusion
- Age ≥ 40 years old
- Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)
- Candidates for HDT-AHCT with one of the following conditioning regimens:
- BEAM (carmustine, etoposide, cytarabine, melphalan)
- BeEAM (bendamustine, etoposide, cytarabine, melphalan)
- Achieved CR or PR prior to planned HDT
- ECOG ≤ 2
- Weight ≤ 1.6 × ideal body weight (IBW) per Devine formula
- Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia
- AST, ALT, and alkaline phosphatase \< 3 × ULN
- Creatinine clearance ≥ 30 ml/min (calculated by Cockcroft Gault)
- LVEF ≥ 45% by MUGA or resting echocardiogram
- Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted
- Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
- 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.
- 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
- Ability to provide written informed consent.
Exclusion
- History of prior HCT
- Primary CNS lymphoma
- Lymphoma with CNS involvement at time of relapse prior to planned HDT-AHCT
- 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
- 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
- Subjects with a known history of HIV
- Subjects who have known hypersensitivity reactions to bovine (cow) proteins or documented allergy to DMSO
- Subject has other conditions that in the opinion of the investigator would require reduced dose (intensity) of BEAM or BeEAM regimens
Key Trial Info
Start Date :
February 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05181540
Start Date
February 21 2022
End Date
January 31 2025
Last Update
February 4 2025
Active Locations (28)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
3
University of California, Los Angeles
Los Angeles, California, United States, 90095
4
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817