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Acute Lymphoblastic LeukemiaPhase 2NCT01685021

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

A Phase 2 study testing MOR00208 (formerly Xmab5574) in people with Acute Lymphoblastic Leukemia, run by MorphoSys AG at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
MOR00208 (formerly Xmab5574)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
3 sitesUnited States
Study dates
Apr 2013to Mar 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Ohio State University Medical Center

    Columbus, Ohio, 43201

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

Other trials in United States

About this study

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)

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)

Being tested
MOR00208 (formerly Xmab5574)
Keywords
B-ALL, CD19, MOR208, MOR00208, Xmab5574, B-cell acute lymphoblastic leukemia, Fc-optimized Anti-CD19 Antibody
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOR00208 (formerly Xmab5574)Drug

    Also called MOR208

Study groups in NCT01685021
Study groupRoleWhat they receive
MOR00208 (formerly Xmab5574)Experimentalintravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody
Receives: Drug: MOR00208 (formerly Xmab5574)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

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

    Antitumor activity of MOR00208

    Measured: Throughout during study until progression, after each treatment cycle

Secondary outcomes (5)

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

    Two patients had a response to treatment. For one of the two patients a progression was recorded, the other patient was censored due to an AE. Conse quently, the planned Kaplan-Meier analyses of response duration and time to hematological relapse could not be calculated.

    Measured: Throughout during study until progression, after each treatment cycle

  2. Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam

    Number of patients with at least one treatment-emergent AE

    Measured: weekly, up to 7 months

  3. Pharmacokinetics of MOR00208

    Steady State Trough Plasma Concentration (Cpre-dose) at 9th dose (infusion)

    Measured: weekly, up to 16 weeks, based on samples taken Pre-dose (ie before infusion start)

  4. Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity

    Measured: monthly, up to 7 months

  5. Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam

    Number of patients with treatment-emergent AEs

    Measured: weekly, up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2012 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685021
Sponsor's protocol ID
MOR208C202
Status last verified
Feb 2018
First submitted
3 Sep 2012
Last updated
22 Feb 2018
Data monitoring committee
No

Publications

  • Klisovic RB, Leung WH, Brugger W, Dirnberger-Hertweck M, Winderlich M, Ambarkhane SV, Jabbour EJ. A phase 2a, single-arm, open-label study of tafasitamab, a humanized, Fc-modified, anti-CD19 antibody, in patients with relapsed/refractory B-precursor cell acute lymphoblastic leukemia. Cancer. 2021 Nov 15;127(22):4190-4197. doi: 10.1002/cncr.33796. Epub 2021 Aug 3.

    PubMed 34343354

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MOR00208 (formerly Xmab5574) in people with Acute Lymphoblastic Leukemia, run by MorphoSys AG at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Throughout during study until progression, after each treatment cycle). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01685021, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.

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