Phase 2
Completed N=24
Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi
Source: ClinicalTrials.gov NCT02639910 ↗Enrolled (actual)
24
Serious AEs
70.8%
Results posted
Jan 2020
Primary outcomePrimary: Incidence and Severity of Adverse Events (AEs) — 11; 13 Participants
Summary
This is a two-cohort, multicenter, open-label study of tafasitamab (MOR208) combined with idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. Patients completing the study treatment are invited to participate in an optional biomarker sub-study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Adverse Events (AEs) |
11; 13 | — |
| SECONDARY Best Objective Response Rate (ORR) |
90.9; 76.9; 90.9; 100 | — |
| SECONDARY Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation |
0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of MOR00208 |
278379.9; 306998.9 | — |
Eligibility Criteria
Major inclusion criteria
Diagnosis/Trial Population
- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):
- history of diagnosis of CLL or SLL that meets IWCLL diagnostic criteria
- histologically confirmed diagnosis of SLL by lymph node biopsy
- indication for treatment as defined by the IWCLL guidelines
- Patients must have both of the following:
- relapsed or refractory disease while receiving a BTKi therapy or intolerance of such therapy
- single-agent or combination therapy with a BTKi for at least one month must be the patient's most recent prior anticancer therapy
- ECOG performance status of 0 to 2
- Patients with a past medical history of autologous or allogeneic stem cell transplantation must exhibit full hematological recovery
Laboratory Values
- Patients must meet adequate bone marrow function and adequate hepatic and renal function
Other Inclusion Criteria
- Females of childbearing potential must use a highly effective method of contraception
Major exclusion criteria
Diagnosis
- Patients who have:
- non-Hodgkin's lymphomas other than CLL/SLL
- transformed CLL/SLL or Richter's syndrome
- active and uncontrolled autoimmune cytopenia
Previous and Current Treatment
- Patients who have received treatment with a BTK inhibitor within 5 days prior to Day 1 dosing
- Patients who have, within 14 days prior to D1 dosing:
- not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
- systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day with the exception of patients with signs of rapidly progressing disease
- received live vaccines with the exception of vaccination against influenza with inactivated virus or for pneumococcal diseases
Data sourced from ClinicalTrials.gov (NCT02639910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.