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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by MorphoSys AG
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG
ClinicalTrials.gov Identifier:
NCT01685008
First received: September 3, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Non-Hodgkin Lymphoma
Drug: MOR00208 (formerly Xmab 5574)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by MorphoSys AG:

Primary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    ORR=CR (Complete Remission) + PR(Partial Remission)

    Antitumor activity of MOR00208



Secondary Outcome Measures:
  • 1. Patients response duration evaluation by hematology, bone marrow aspirated or biopsy, CT [ Time Frame: bi monthly, up to 48 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 4. Number of patients who develop anti-MOR00208 antibodies as a measure of immunogenicity [ Time Frame: monthly up to 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MOR00208 (formerly Xmab5574)
intravenous Infusion of MOR00208, Fc-Optimized Anti-CD19 Antibody
Drug: MOR00208 (formerly Xmab 5574)
Other Name: MOR208

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685008

Contacts
Contact: Roman Korolkiewicz +49 89 89927 ext 0 info@morphosys.com

Locations
United States, Connecticut
MorphoSys Research Site Recruiting
Norwalk, Connecticut, United States, 06856
Contact: Jennifer Long    203-852-2996    jennifer.long@norwalkhealth.org   
Principal Investigator: Richard Frank, MD         
United States, New Jersey
MorphoSys Research Site Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Andre Goy, MD    201-336-8772    agoy@humed.com   
Contact: Kara Yannotti    201-495-0605    kyannotti@hackensackumc.org   
Principal Investigator: Andre Goy, MD         
United States, Ohio
Morphosys Research Site Active, not recruiting
Columbus, Ohio, United States, 43201
United States, Texas
Morphosys Research Site Recruiting
Lubbock, Texas, United States, 79410
Contact: Donald Quick, MD    806-725-8000      
Contact: Erin Cotton    806.725.8001    cottone1@covhs.org   
Principal Investigator: Donald Quick, MD         
Belgium
MorphoSys Research Site Recruiting
Brussels #1, Belgium
MorphoSys Research Site Not yet recruiting
Brussels #2, Belgium
MorphoSys Research Site Active, not recruiting
Edegem, Belgium
Germany
MorphoSys Research Site Recruiting
Berlin, Germany
MorphoSys Research Site Recruiting
Mainz, Germany
Morphosys Research Site Not yet recruiting
Ulm, Germany
Hungary
Morphosys Research Site Recruiting
Budapest #1, Hungary
MorphoSys Research Site Not yet recruiting
Budapest #2, Hungary
Morphosys Research Site Recruiting
Debrecen, Hungary
Italy
MorphoSys Research Site Recruiting
Bologna, Italy
MorphoSys Research Site Not yet recruiting
Firenze, Italy
Morphosys Recruiting
Genova, Italy
Morphosys Research Site Not yet recruiting
Modena, Italy
Morphosys Research Site Recruiting
Novara, Italy
Poland
MorphoSys Research Site Recruiting
Chorzów, Poland
Morphosys Research Site Recruiting
Kraków, Poland
Morphosys Research Site Recruiting
Lódz, Poland
MorphoSys Research Site Not yet recruiting
Slupsk, Poland
Spain
Morphosys Research Site Recruiting
Madrid #1, Spain
Morphosys Research Site Recruiting
Madrid #2, Spain
MorphoSys Research Site Recruiting
Madrid #3, Spain
Morphosys Research Site Not yet recruiting
Sevilla, Spain
Sponsors and Collaborators
MorphoSys AG
Investigators
Principal Investigator: Kristi Blum, MD Ohio State University
  More Information

No publications provided

Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT01685008     History of Changes
Other Study ID Numbers: MOR208C201, 2012-002659-41
Study First Received: September 3, 2012
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Hungary: National Institute of Pharmacy
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by MorphoSys AG:
NHL
CD19
MOR208
MOR00208
Xmab5574
B-Cell Non-Hodgkin´s Lymphoma
Fc-optimized Anti-CD19 Antibody

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014