This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL).
The aim of this single-arm, multicentre, open-label Phase II study is to evaluate the Lenalidomide (LEN) combined with Tafasitamab (MOR00208) in adult participants with DLBCL who had relapsed after or were refractory to at least one, but no more than three previous systemic regimens administered for the treatment of their DLBCL and who were not candidates for high-dose chemotherapy and subsequent Autologous stem cell transplants and were thus considered to have exhausted their therapeutic options. One prior therapy line had to include an anti-CD20 targeted therapy (e.g., rituximab \[RTX\]). MOR00208 and LEN were administered for up to 12 cycles (28 days each), followed by MOR00208 monotherapy until progression, in participants with at least stable disease or a better response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
12 mg/kg
25 mg
Number of Participants With Best Objective Response Rate (ORR)
ORR = complete response \[CR\] + partial response \[PR\]; Independent Radiology/Clinical Review Committee (IRC) Evaluation. ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation. ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Duration of Response (DoR) by IRC Evaluation
DoR \[months\] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
DoR by Investigator (INV) Evaluation
DoR \[months\] = (date of assessment of tumour progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Progression-free Survival (PFS) by IRC Evaluation
PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
PFS by INV Evaluation
PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States
UCLA - David Geffen School of Medicine
Los Angeles, California, United States
Cancer Care - Torrance Memorial Physician Network
Redondo Beach, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
St. Mary's Hospital And Regional Medical Center
Grand Junction, Colorado, United States
Norwalk Hospital
Norwalk, Connecticut, United States
St. Joseph Mercy Hospital Cancer Care Center
Ypsilanti, Michigan, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, United States
Tyler Hematology-Oncology
Tyler, Texas, United States
...and 47 more locations
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Overall Survival (OS)
OS was defined as the time from the date of the first administration of any study drug until death from any cause (documented by the date of death).
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Disease Control Rate (DCR) by IRC Evaluation
DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.
Time frame: Approximately 2.5 years after first participant enrolled
DCR by INV Evaluation
DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.
Time frame: Approximately 2.5 years after first participant enrolled
Time to Progression (TTP) by IRC Evaluation
TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
Time frame: Approximately 2.5 years after first participant enrolled
TTP by INV Evaluation
TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
Time frame: Approximately 2.5 years after first participant enrolled
Time to Next Treatment (TTNT)
Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Event-free Survival (EFS) by IRC Evaluation
EFS is defined as the time (in months) from the date of the first administration of any study drug to the date of tumour progression, first initiation of a new non-study anti-neoplastic therapy or death from any cause whichever comes first.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Serum Drug Levels of MOR00208
The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling. MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).
Time frame: Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment
Number of Participants Who Developed Anti-MOR00208 Antibodies
The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23).
Time frame: Baseline, Up to a maximum of 23 cycles.
Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs)
TEAEs are defined as any adverse event reported in the following time interval (including the lower and upper limits): date of first administration of study treatment; date of last administration of study treatment + 30 days, or if they are considered to be related to the study drug.
Time frame: Approximately 6.5 years after first participant enrolled
Severity of Treatment-emergent Adverse Events (TEAEs)
Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy.
Time frame: Approximately 6.5 years after first participant enrolled