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Trial record 2 of 6 for:    Lymphoma | Morphosys | Adult | Phase 2

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

This study is currently recruiting participants.
Verified August 2017 by MorphoSys AG
Sponsor:
ClinicalTrials.gov Identifier:
NCT02399085
First Posted: March 26, 2015
Last Update Posted: August 11, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
MorphoSys AG
  Purpose
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 Intervention Phase
Diffuse Large B-cell Lymphoma Drug: MOR00208 Drug: Lenalidomide Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by MorphoSys AG:

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

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

  • Duration of response (DoR) [ Time Frame: 3 years ]
  • Progression-free survival (PFS) [ Time Frame: 3 years ]
  • Overall survival (OS) [ Time Frame: 3 years ]
  • 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)

  • 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

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


Estimated Enrollment: 80
Study Start Date: December 2015
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (MOR00208, lenalidomide)

MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4-24), 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 Name: MOR208
Drug: Lenalidomide
25 mg
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


Contacts
Contact: Sumeet V Ambarkhane, MD sumeet.ambarkhane@morphosys.com

  Show 53 Study Locations
Sponsors and Collaborators
MorphoSys AG
Investigators
Study Director: Sumeet V Ambarkhane, MD Clinical Program Leader
  More Information

Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT02399085     History of Changes
Other Study ID Numbers: MOR208C203
First Submitted: March 13, 2015
First Posted: March 26, 2015
Last Update Posted: August 11, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents