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

Tracking Information
First Submitted Date  ICMJE March 13, 2015
First Posted Date  ICMJE March 26, 2015
Last Update Posted Date June 6, 2019
Study Start Date  ICMJE March 2016
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
Objective response rate (ORR = complete response [CR] + partial response [PR]) [ Time Frame: 1-3 years approximately ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
Objective response rate (ORR = complete response [CR] + partial response [PR]) [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT02399085 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • Disease control rate (DCR) [ Time Frame: 1-3 years approximately ]
    DCR = CR + PR + SD
  • Duration of response (DoR) [ Time Frame: 1-3 years approximately ]
  • Progression-free survival (PFS) [ Time Frame: 1-3 years approximately ]
  • Overall survival (OS) [ Time Frame: 1-3 years approximately ]
  • 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)
  • 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
  • Pharmacokinetics (PK) of MOR00208 [ Time Frame: upto 2 years ]
    time to maximum serum concentration [tmax]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
  • 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 ]
  • Time to progression (TTP) [ Time Frame: 3 years ]
  • 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.
  • 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 ]
    maximum serum concentration [Cmax]
  • Pharmacokinetics (PK) of MOR00208 [ Time Frame: 2 years ]
    time to maximum serum concentration [tmax]
  • Pharmacokinetics (PK) of MOR00208 [ Time Frame: 2 years ]
    apparent trough serum concentration before dosing [Cpd]
  • 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]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-cell Lymphoma
Intervention  ICMJE
  • Drug: MOR00208
    12 mg/kg
    Other Name: MOR208
  • Drug: Lenalidomide
    25 mg
    Other Names:
    • CC-5013
    • IMiD-1
    • Revlimid
Study Arms  ICMJE 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.

Interventions:
  • Drug: MOR00208
  • Drug: Lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2017)
81
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2015)
80
Estimated Study Completion Date  ICMJE November 2022
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czechia,   France,   Germany,   Hungary,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02399085
Other Study ID Numbers  ICMJE MOR208C203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MorphoSys AG
Study Sponsor  ICMJE MorphoSys AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sumeet V Ambarkhane, MD Clinical Program Leader
PRS Account MorphoSys AG
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP