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Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin´s Lymphoma (NHL)

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ClinicalTrials.gov Identifier: NCT01685008
Recruitment Status : Active, not recruiting
First Posted : September 13, 2012
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Tracking Information
First Submitted Date  ICMJE September 3, 2012
First Posted Date  ICMJE September 13, 2012
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE April 23, 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
Overall response rate (ORR) [ Time Frame: up to 4 years ]
Proportion of Patients with Complete Response (CR) or Partial Response (PR)
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
Overall response rate (ORR) [ Time Frame: 4 years ]
ORR=CR (Complete Remission) + PR(Partial Remission) Antitumor activity of MOR00208
Change History Complete list of historical versions of study NCT01685008 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Stable Disease (SD) Rate [ Time Frame: up to 4 years ]
    Proportion of Patients with Stable Disease
  • Duration of Response (DoR) [ Time Frame: up to 4 years ]
    Time from first CR or PR to first documentation of relapse/progression
  • Time to Progression (TTP) [ Time Frame: up to 4 years ]
    Time from first dosing until documentation of progression or death due to lymphoma
  • Progression-free Survival (PFS) [ Time Frame: up to 4 years ]
    Time from first dosing until progression or death due to any case
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
  • 1. Patients response duration evaluation by hematology, bone marrow aspirated or biopsy, CT [ Time Frame: bi monthly, up to 48 months ]
  • 2. Safety will be evaluated by assessing adverse events, clinical lab data and vital signs, ECG, physical exam [ Time Frame: weekly, up to 4 years ]
  • 3. Pharmacokinetics of MOR00208 (Pharmacokinetic assessment comprises: Cmax, tmax, t1/2, CL [ Time Frame: weekly, up to 12 weeks; 0, 1, 4, 24 hours post dose ]
  • 4. Number of patients who develop anti-MOR00208 antibodies as a measure of immunogenicity [ Time Frame: monthly up to 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin´s Lymphoma (NHL)
Official Title  ICMJE A Phase IIa, Open-label, Multicenter Study of Single-Agent MOR00208, an Fc-optimized Anti-CD19 Antibody in Patients With Relapsed or Refractory Non-Hodgkin´s Lymphoma (NHL)
Brief Summary This is an open-label, multicentre study to characterize the safety and preliminary efficacy of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory non-Hodgkin´s lymphoma (NHL) who have received at least 1 prior therapy containing rituximab (at least once).
Detailed Description The study enrols patients from four different NHL subtypes: FL, DLBCL, MCL and other indolent NHL. The study will employ a two-stage design where the decision to further enrol any NHL subtype in stage 2 will depend on best responses after two or three cycles in stage 1.
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 Non-Hodgkin Lymphoma
Intervention  ICMJE Drug: MOR00208 (formerly Xmab 5574)
Other Name: MOR208
Study Arms  ICMJE Experimental: MOR00208 (formerly Xmab5574)
intravenous Infusion of MOR00208, Fc-Optimized Anti-CD19 Antibody
Intervention: Drug: MOR00208 (formerly Xmab 5574)
Publications * Jurczak W, Zinzani PL, Gaidano G, Goy A, Provencio M, Nagy Z, Robak T, Maddocks K, Buske C, Ambarkhane S, Winderlich M, Dirnberger-Hertweck M, Korolkiewicz R, Blum KA. Phase IIa study of the CD19 antibody MOR208 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Ann Oncol. 2018 May 1;29(5):1266-1272. doi: 10.1093/annonc/mdy056.

*   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
Actual Enrollment  ICMJE
 (submitted: June 25, 2019)
92
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2012)
120
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. male or female patients ≥ 18 years of age.
  2. histologically-confirmed diagnosis according to REAL/WHO classification, of the following B-cell lymphomas :

    1. FL
    2. MCL
    3. DLBCL
    4. Other indolent NHL (eg, MZL/MALT)
  3. Patients' NHL must have progressed after at least 1 prior rituximab containing regimen.
  4. one site of measurable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan defined as at least one lesion that measures at least 1.5 × 1.5 cm,

    Exception:

    For patients with MCL only, patients with nonmeasurable disease but evaluable sites (bone marrow, spleen, peripheral blood, gastrointestinal tract) can be enrolled.

  5. Patients who have previously received an autologous stem cell transplantation must be at least 4 weeks post-transplant before study drug administration and must have exhibited a full haematological recovery
  6. discontinued previous monoclonal antibody therapy (except rituximab) or radioimmunotherapy administration for at least 60 days before study drug administration.
  7. off rituximab for at least 14 days before the screening visit and be confirmed to have either no response or have disease progression after rituximab treatment.
  8. Patients with DLBCL had a positive [18F]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan at baseline (Cheson response criteria)
  9. Life expectancy of > 3 months.
  10. ECOG performance status of < 3.
  11. laboratory criteria at screening:

    1. Absolute neutrophil count (ANC) ≥ 1.0 (1000/mm3)
    2. Platelet count ≥ 75 × 109/L without previous transfusion within 10 days of first study drug administration
    3. Haemoglobin ≥ 8.0 g/dL (may have been transfused)
    4. Serum creatinine < 2.0 x upper limit of normal (ULN)
    5. Total bilirubin ≤ 2.0 × ULN
    6. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
  12. If a female of childbearing potential, a negative pregnancy test must be confirmed before enrolment and use of double-barrier contraception, oral contraceptive plus barrier contraceptive, or confirmation of having undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation.
  13. If a male, an effective barrier method of contraception must be used during the study and for 3 months after the last dose if the patient is sexually active with a female of childbearing potential.
  14. able to comply with all study-related procedures, medication use, and evaluations.
  15. able understand and give written informed consent and comply with the study protocol.

Exclusion Criteria:

  1. Previous treatment with cytotoxic chemotherapy, immunotherapy, radiotherapy or other lymphoma specific therapy within 14 days before the screening visit or patient has not recovered from side effects of previous lymphoma-specific therapy.
  2. Treatment with a systemic investigational agent within 28 days before the screening visit.
  3. Previous treatment with an anti-CD19 antibody or fragments
  4. Previous allogenic stem cell transplantation.
  5. Known or suspected hypersensitivity to the excipients contained in the study drug formulation.
  6. Clinically significant cardiovascular disease or cardiac insufficiency,cardiomyopathy, preexisting clinically significant arrhythmia, acute myocardial infarction within 3 months of enrolment, angina pectoris within 3 months of enrolment.
  7. Clinical or laboratory evidence of active hepatitis B or hepatitis C 8. History of HIV infection.

9. Any active systemic infection (viral, fungal, or bacterial) requiring active parenteral antibiotic therapy within 4 weeks of study drug administration.

10. Current treatment with immunosuppressive agents other than prescribed corticosteroids (not more than 10-mg prednisone equivalent).

11. Major surgery or radiation therapy within 4 weeks before first study drug administration.

12. Systemic diseases (cardiovascular, renal, hepatic, etc) that would prevent study treatment in the investigator's opinion.

13. History or clinical evidence of central nervous system (CNS), meningeal, or epidural disease, including brain metastasis.

14. Active treatment/chemotherapy for another primary malignancy within the past 5 years 15. Pregnancy or breastfeeding in women and women of childbearing potential not using an acceptable method of birth control.

16. History of noncompliance to medical regimens or patients who are considered potentially unreliable not cooperative

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,   Germany,   Hungary,   Italy,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01685008
Other Study ID Numbers  ICMJE MOR208C201
2012-002659-41 ( EudraCT Number )
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
Principal Investigator: Kristi Blum, MD Ohio State University
PRS Account MorphoSys AG
Verification Date December 2019

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