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History of Changes for Study: NCT02399085
A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL
Latest version (submitted September 28, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 25, 2015 None (earliest Version on record)
2 August 31, 2015 Study Status, Eligibility, Arms and Interventions and Oversight
3 December 23, 2015 Recruitment Status, Study Status and Contacts/Locations
4 February 5, 2016 Contacts/Locations and Study Status
5 March 9, 2016 Contacts/Locations and Study Status
6 October 21, 2016 Contacts/Locations, Study Status, Eligibility, Outcome Measures and Study Description
7 December 15, 2016 Study Status and Study Identification
8 August 9, 2017 Study Status and Contacts/Locations
9 December 5, 2017 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures, Arms and Interventions, Study Design and Conditions
10 June 4, 2019 Study Status
Show
Results Submission Events
11 January 23, 2020 Outcome Measures, Study Status, Document Section, Results, Arms and Interventions and Study Design
12 February 5, 2020 Study Status
13 September 1, 2021 References, Contacts/Locations, Study Status and Oversight
14 February 9, 2023 Recruitment Status, Contacts/Locations, Study Status and Participant Flow
15 February 9, 2023 Participant Flow, Contacts/Locations and Study Status
16 March 13, 2023 Study Status
17 September 28, 2023 Outcome Measures, Adverse Events, Document Section, Participant Flow, References, Arms and Interventions, Study Status, More Information, Study Description, Study Identification, Baseline Characteristics, IPDSharing, Contacts/Locations, Eligibility and Conditions
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Study NCT02399085
Submitted Date:  March 25, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: MOR208C203
Brief Title: A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL
Official Title: A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Not yet recruiting
Study Start: June 2015
Primary Completion: July 2018 [Anticipated]
Study Completion: June 2019 [Anticipated]
First Submitted: March 13, 2015
First Submitted that
Met QC Criteria:
March 25, 2015
First Posted: March 26, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 25, 2015
Last Update Posted: March 26, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: MorphoSys AG
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This is an open-label, multicentre study to characterize the safety and efficacy of the human anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no more than two prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.
Detailed Description:
Open or close this module Conditions
Conditions: Diffuse Large B-cell Lymphoma
Keywords: DLBCL
CD19
monoclonal antibody
MOR00208
MOR208
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Treatment (MOR00208, lenalidomide)

Weekly intravenous Infusion of MOR00208 Fc-Optimized Anti-CD19 Antibody, 4 weeks cycles, up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Lenalidomide (Revlimid®), PO, daily, 4 weeks cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity

Drug: MOR00208
12 mg/kg
Other Names:
  • MOR208
Drug: Lenalidomide
25 mg
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective response rate (ORR = complete response [CR] + partial response [PR])
[ Time Frame: 3 years ]

Secondary Outcome Measures:
1. Disease control rate (DCR)
[ Time Frame: 3 years ]

DCR = CR + PR + SD
2. Duration of response (DoR)
[ Time Frame: 3 years ]

3. Progression-free survival (PFS)
[ Time Frame: 3 years ]

4. Overall survival (OS)
[ Time Frame: 3 years ]

5. Time to progression (TTP)
[ Time Frame: 3 years ]

6. Time to next treatment (TTNT)
[ Time Frame: 3 years ]

TTNT is defined as the time from study entry (= first dosing) to the institution of next therapy for any reason including disease progression, treatment toxicity and patient preference. TTNT will be descriptively analysed.
7. Safety of LEN combined with MOR00208 according to the frequency and severity of adverse events (AEs)
[ Time Frame: 2 years ]

Safety profile is assessed according to the frequency and severity of adverse events (AEs)
8. Potential immunogenicity of MOR00208
[ Time Frame: 2 years ]

The absolute number and percentage of patients, who develop anti-MOR00208 antibodies, and the results of semi-quantitative anti-MOR00208 antibody titre determinations of confirmed positive sample assessments will be tabulated
9. Pharmacokinetics (PK) of MOR00208
[ Time Frame: 2 years ]

maximum serum concentration [Cmax]
10. Pharmacokinetics (PK) of MOR00208
[ Time Frame: 2 years ]

time to maximum serum concentration [tmax]
11. Pharmacokinetics (PK) of MOR00208
[ Time Frame: 2 years ]

apparent trough serum concentration before dosing [Cpd]
12. Pharmacokinetics (PK) of MOR00208
[ Time Frame: 2 years ]

area under the serum concentration versus time curve from time 0 to the time t of the last quantifiable concentration [AUC0-t]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Major Inclusion Criteria:

  1. Age 18-80 years old
  2. Histologically confirmed diagnosis of DLBCL
  3. Fresh tumour tissue for central pathology review and correlative studies must be provided. The only exception is the availability of tumour tissue acquired ≤3 years prior to screening for this protocol
  4. Patients must have:
    • relapsed and/or refractory disease
    • at least one bidimensionally measurable disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
    • received at least one, but no more than two previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy
    • Eastern Cooperative Oncology Group 0 to 2
  5. Patients not considered in the opinion of the investigator eligible, or patients unwilling to undergo intensive salvage therapy including ASCT
  6. Patients must meet the following laboratory criteria at screening:
    • absolute neutrophil count ≥1.5 × 109/L
    • platelet count ≥90 × 109/L
    • total serum bilirubin ≤2.5 × ULN or ≤3 × ULN in cases of liver involvement
    • alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or <5 × ULN in cases of liver involvement
    • serum creatinine clearance ≥60 mL/minute
  7. Females of childbearing potential (FCBP) must:
    • not be pregnant
    • refrain from breastfeeding and donating blood or oocytes
    • agree to ongoing pregnancy testing
    • commit to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
  8. Males (if sexually active with a FCBP) must
    • use an effective barrier method of contraception
    • refrain from donating blood or sperm
  9. In the opinion of the investigator the patients must:
    • be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
    • be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.

Major Exclusion Criteria:

  1. Patients who have:
    • Non Hodgkin Lymphoma other than classical histology DLBCL
    • primary refractory DLBCL or relapsed within period ≤3 months of prior CD20-targeted therapy
    • a history of "double/triple hit" DLBCL
  2. Patients who have, within 14 days prior to Day 1 dosing:
    • not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
    • undergone major surgery or suffered from significant traumatic injury
    • received live vaccines.
    • required parenteral antimicrobial therapy for active, intercurrent infections
  3. Patients who:
    • were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN)
    • have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
    • have undergone previous allogenic stem cell transplantation
    • have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
    • concurrently use other anticancer or experimental treatments
  4. Prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥3 years prior to screening.
  5. Patients with:
    • positive hepatitis B and/or C serology.
    • known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
    • history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent.
Open or close this module Contacts/Locations
Central Contact Person: Roman P Korolkiewicz, MD PhD
Email: roman.korolkiewicz@morphosys.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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