Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

Part of paid clinical trials in Bakersfield, California.

Sponsor
MorphoSys AG
Study ID
NCT02399085
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Mar 29, 2016
Status verified
Sep 2023
Primary completion
Nov 14, 2022
Completion
Apr 19, 2023

Study Design

Enrollment
81 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tafasitamab (MOR00208) + lenalidomide (LEN)
    MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.

Primary Outcome Measure

Number of Participants With Best Objective Response Rate (ORR) [ Time Frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled ]

Locations (10)

FacilityCityStateZIPSite coordinators
CBCC Global Research, Inc. at Comprehensive Blood and Cancer CenterBakersfieldCalifornia93309-
UCLA - David Geffen School of MedicineLos AngelesCalifornia90095-
Cancer Care - Torrance Memorial Physician NetworkRedondo BeachCalifornia90277-
Central Coast Medical Oncology CorporationSanta MariaCalifornia93454-
St. Mary's Hospital And Regional Medical CenterGrand JunctionColorado81501-
Norwalk HospitalNorwalkConnecticut06856-
St. Joseph Mercy Hospital Cancer Care CenterYpsilantiMichigan48179-
Ohio State University Medical CenterColumbusOhio43210-
Charleston Hematology Oncology AssociatesCharlestonSouth Carolina29414-
Tyler Hematology-OncologyTylerTexas75701-

Find similar trials in Bakersfield, CA

By research site
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center· Bakersfield, CAUCLA - David Geffen School of Medicine· Los Angeles, CACancer Care - Torrance Memorial Physician Network· Redondo Beach, CACentral Coast Medical Oncology Corporation· Santa Maria, CASt. Mary's Hospital And Regional Medical Center· Grand Junction, CONorwalk Hospital· Norwalk, CT

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