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A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL (L-MIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02399085
Recruitment Status : Completed
First Posted : March 26, 2015
Results First Posted : February 5, 2020
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Study Description
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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 three 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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: MOR00208 Drug: Lenalidomide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (MOR00208, lenalidomide)

MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

Lenalidomide (Revlimid®), PO, daily, 4 week 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 Name: MOR208

Drug: Lenalidomide
25 mg
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Best Objective Response Rate [ Time Frame: 1-3 years approximately ]
    ORR = complete response [CR] + partial response [PR]; IRC Evaluation


Secondary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: 1-3 years approximately ]
    DCR = CR + PR + SD; IRC Evaluation

  2. Duration of Response (DoR) [ Time Frame: 1-3 years approximately ]
    IRC Evaluation

  3. Progression-free Survival (PFS) [ Time Frame: 1-3 years approximately ]
    IRC Evaluation

  4. Percentage of Participants With Overall Survival (OS) [ Time Frame: Approximately 32 months between first patient first visit and primary outcome completion date ]
    Overall survival was defined as first administration of IMP and deaths due to any cause. Percentage of patients alive at 12 months from the start of their study participation is reported.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  1. Age >18 years
  2. Histologically confirmed diagnosis of DLBCL
  3. Tumour tissue for central pathology review and correlative studies must be provided.

  4. Patients must have:

    • relapsed and/or refractory disease
    • at least one bidimensionally measurable, PET positive 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 three 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 ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
    • 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:

    • other histological type of lymphoma
    • primary refractory DLBCL
    • a history of "double/triple hit" genetics

  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 ≥5 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)
    • CNS lymphoma involvement
    • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399085


Locations
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Sponsors and Collaborators
MorphoSys AG
  Study Documents (Full-Text)

Documents provided by MorphoSys AG:
Study Protocol and Statistical Analysis Plan  [PDF] March 4, 2015

More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT02399085    
Other Study ID Numbers: MOR208C203
First Posted: March 26, 2015    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: March 15, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by MorphoSys AG:
DLBCL
CD19
monoclonal antibody
 MOR00208
MOR208
lenalidomide
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents