Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Ma… (NCT02290951) | Clinical Trial Compass
CompletedPhase 1
Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
United States200 participantsStarted 2015-01-09
Plain-language summary
This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate:
✓. Patients with B-NHL must have had prior treatment with an anti-CD20 antibody therapy. Patients with CLL (Part A only) are not required to have received prior treatment with an anti-CD20 antibody therapy as defined in the protocol.
✓. All patients must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or MRI scan, if CT scan is not feasible.
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
✓. Life expectancy of at least 6 months
✓. Adequate bone marrow function as described in the protocol
✓. Adequate organ function as described in the protocol
✓. Willingness to undergo mandatory tumor biopsy pretreatment, if in the opinion of the investigator, the patient has an accessible lesion that can be biopsied without significant risk to the patient.
Exclusion criteria
✕. Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL
✕. History of or current relevant CNS pathology such as
✕. Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug
What they're measuring
1
Safety/overall frequency of adverse events (AEs)
Timeframe: Up to 24 months
2
Safety/dose limiting toxicities (DLTs)
Timeframe: Up to 28 days
3
Antitumor activity as measured by the objective response rate (ORR)
Timeframe: Through study completion, an average of 24 months
✕. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) infection \[(as noted by detectable levels on a blood polymerase chain reaction (PCR) assay)\].
✕. Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus deoxyribonucleic acid (DNA) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted upon consultation with the physician managing the infection.
✕. Patients who show detectable levels of CMV at screening will need to be treated with appropriate antiviral therapy and demonstrate at least 2 undetectable levels of CMV by PCR assay (at least 7 days apart) before being re-considered for eligibility.
✕. Patients who have received a live vaccination within 28 days of first dose of study treatment