Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 7 for:    mor208

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 : Active, not recruiting
First Posted : March 26, 2015
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
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)
Study Start Date : March 2016
Actual Primary Completion Date : November 2018
Estimated Study Completion Date : November 2022


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 weeks cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

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 Name: MOR208

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




Primary Outcome Measures :
  1. Objective response rate (ORR = complete response [CR] + partial response [PR]) [ Time Frame: 1-3 years approximately ]

Secondary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: 1-3 years approximately ]
    DCR = CR + PR + SD

  2. Duration of response (DoR) [ Time Frame: 1-3 years approximately ]
  3. Progression-free survival (PFS) [ Time Frame: 1-3 years approximately ]
  4. Overall survival (OS) [ Time Frame: 1-3 years approximately ]
  5. Safety of LEN combined with MOR00208 according to the frequency and severity of adverse events (AEs) [ Time Frame: 1-3 years approximately ]
    Safety profile is assessed according to the frequency and severity of adverse events (AEs)

  6. Potential immunogenicity of MOR00208 [ Time Frame: upto 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

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



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.


Layout table for eligibility information
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.

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


  Hide Study Locations
Locations
Layout table for location information
United States, California
MorphoSys Research Site
Bakersfield, California, United States, 93309
MorphoSys Research Site
Redondo Beach, California, United States, 90277
MorphoSys Research Site
Santa Maria, California, United States, 93454
United States, Colorado
MorphoSys Research Site
Grand Junction, Colorado, United States, 81501
United States, Connecticut
MorphoSys Research Site
Norwalk, Connecticut, United States, 06856
United States, Michigan
MorphoSys Research Site
Michigan Center, Michigan, United States, 48179
United States, Ohio
MorphoSys Research Site
Columbus, Ohio, United States, 43210
United States, South Carolina
MorphoSys Research Site
Charleston, South Carolina, United States, 29414
United States, Texas
MorphoSys Research Site
Tyler, Texas, United States, 75701
Belgium
MorphoSys Research Site
Antwerp, Belgium, 2020
MorphoSys Research Site
Kortrijk, Belgium, 8500
MorphoSys Research Site
Liege, Belgium, 4000
MorphoSys Research Site
Yvoir, Belgium, 5530
Czechia
MorphoSys Research Site
Olomouc, Czechia
France
MorphoSys Research Site
Clermont-Ferrand, France, 63000
MorphoSys Research Site
Limoges, France, 87042
MorphoSys Research Site
Lyon, France, 69495
MorphoSys Research Site
Paris, France, 75015
Germany
MorphoSys Research Site
Essen, Germany, 45147
MorphoSys Research Site
Frankfurt, Germany, 60488
MorphoSys Research Site
Munich, Germany
MorphoSys Research Site
Nürnberg, Germany, 90419
MorphoSys Research Site
Würzburg, Germany, 97080
Hungary
MorphoSys Research Site
Budapest, Hungary, 1122
MorphoSys Research Site
Budapest, Hungary
MorphoSys Research Site
Debrecen, Hungary, 4032
Italy
MorphoSys Research Site
Bari, Italy, 70124
MorphoSys Research Site
Bologna, Italy
MorphoSys Research Site
Firenze, Italy, 50134
MorphoSys Research Site
Modena, Italy, 41124
MorphoSys Research Site
Novara, Italy, 28100
MorphoSys Research Site
Perugia, Italy, 6132
MorphoSys Research Site
Roma, Italy, 133
MorphoSys Research Site
Terni, Italy, 5100
Poland
MorphoSys Research Site
Krakow, Poland
MorphoSys Research Site
Olsztyn, Poland, 10228
MorphoSys Research Site
Opole, Poland, 45061
MorphoSys Research Site
Poznan, Poland, 60631
MorphoSys Research Site
Rzeszow, Poland, 35055
MorphoSys Research Site
Warszawa, Poland, 02106
MorphoSys Research Site
Warszawa, Poland, 02781
Spain
MorphoSys Research Site
Barcelona, Spain, 8035
MorphoSys Research Site
Barcelona, Spain, 8908
MorphoSys Research Site
Barcelona, Spain, 8916
MorphoSys Research Site
Madrid, Spain, 28040
MorphoSys Research Site
Madrid, Spain, 28223
MorphoSys Research Site
Madrid, Spain
MorphoSys Research Site
Pamplona, Spain, 31008
MorphoSys Research Site
Sevilla, Spain, 41013
United Kingdom
MorphoSys Research Site
Bournemouth, United Kingdom, BH77DW
MorphoSys Research Site
Liverpool, United Kingdom
MorphoSys Research Site
London, United Kingdom, W1G 6AD
MorphoSys Research Site
Newcastle, United Kingdom, NE7 7DN
Sponsors and Collaborators
MorphoSys AG
Investigators
Layout table for investigator information
Study Director: Sumeet V Ambarkhane, MD Clinical Program Leader

Layout table for additonal information
Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT02399085     History of Changes
Other Study ID Numbers: MOR208C203
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

Keywords provided by MorphoSys AG:
DLBCL
CD19
monoclonal antibody
MOR00208
MOR208
lenalidomide

Additional relevant MeSH terms:
Layout table for MeSH terms
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