Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL)

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Brief Title

Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL)

Official Title

A Phase IIa, Single-arm, Open-label Study of MOR00208, a Humanized Fc-Engineered Anti-CD19 Antibody, in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)

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 B-cell
      acute lymphoblastic leukemia (B-ALL)
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Response Rate (ORR)

Secondary Outcome

 Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT

Condition

Acute Lymphoblastic Leukemia

Intervention

MOR00208 (formerly Xmab5574)

Study Arms / Comparison Groups

 MOR00208 (formerly Xmab5574)
Description:  intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

22

Start Date

April 2013

Completion Date

March 2015

Primary Completion Date

March 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with previously treated Philadelphia-chromosome-negative B-ALL, with
             progression after at least one prior therapy. Patients with
             Philadelphia-chromosome-positive B-ALL can only be included if they are refractory or
             intolerant to at least one tyrosine-kinase-inhibitor.

          -  Male or female patients at least 16 years of age; if the patient is less than 18 years
             of age, the patient must have the ability to understand and give written assent in
             addition to the parent's/guardian's written informed consent.

          -  Patients with histologically confirmed diagnosis of B-ALL

          -  Mixed phenotype acute leukemia patients who have B cell immunophenotype.

          -  Patients with an Eastern Cooperative Oncology Group performance status of less than or
             equal to 2

          -  Patients with a total bilirubin of less than or equal to 2.0 mg/dL

          -  Patients with alanine aminotransferase or aspartate aminotransferase less than or
             equal to 2.5 times the upper limit of normal

          -  Patients with a creatinine level of less than or equal to 2.0 mg/dL

          -  If a female of childbearing potential, confirmation of a negative pregnancy test
             before enrollment and use of double-barrier contraception, confirmation of a negative
             pregnancy test before enrollment and use of oral contraceptive plus barrier
             contraceptive, or confirmation of having undergone clinically documented total
             hysterectomy, oophorectomy, or tubal ligation

          -  If a male, use of an effective barrier method of contraception during the study and
             for 3 months after the last dose if sexually active with a female of childbearing
             potential

          -  Patients with the ability to understand and give written informed consent and to
             comply with the study protocol

        Exclusion Criteria:

          -  Patients who received previous treatment with an anti-CD19 antibody or fragments

          -  Receipt of anti-CD20 therapy no greater than 4 weeks before the first study dose

          -  Patients having undergone prior allogeneic stem cell transplantation within 3 months
             or having active graft versus host disease

          -  Patients with known hypersensitivity to any excipient contained in the drug
             formulation

          -  Patients with a New York Heart Association Class III or IV

          -  History of stroke or myocardial infarction within the last 6 months

          -  Patients with a history of positive human immunodeficiency virus test result (ELISA or
             western blot)

          -  Patients with positive hepatitis serology. Hepatitis B (HBV): Patients with positive
             serology for hepatitis B, defined as positive for hepatitis B surface antigen (HbsAg)
             or total anti-hepatitis B core antibody (anti-Hbc). Patients positive for anti- Hbc
             may be included if hepatitis B viral DNA is not detectable. Hepatitis C (HCV):
             Patients with positive hepatitis C serology (defined as positive for anti-hepatitis C
             virus antibody (anti-HCV) unless HCV-RNA is confirmed negative.

          -  Patients with active viral, bacterial, or systemic fungal infection requiring active
             parenteral treatment

          -  Patients who are receiving active treatment/chemotherapy for another primary
             malignancy or have received any treatment, including surgery, radiation, or
             chemotherapy, within the past 5 years (except ductal breast cancer in situ, for
             nonmelanoma skin cancer, prostate cancer not requiring treatment, and cervical
             carcinoma in situ)

          -  Patients who are pregnant or breastfeeding

          -  Patients with major surgery or radiation therapy within 4 weeks prior to first study
             dose
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Elias Jabbour, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01685021

Organization ID

MOR208C202


Responsible Party

Sponsor

Study Sponsor

MorphoSys AG


Study Sponsor

Elias Jabbour, MD, Principal Investigator, MDA


Verification Date

February 2018