Phase I/II, First in Human, Dose Escalation Trial of the Bruton's Tyrosine Kinase Inhibitor M7583 in Patients With Relapsed/Refractory B Cell Malignancies and Expansion Cohorts in Patients With Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma (ABC Subtype) That Have Progressed After at Least 1 But Not More Than 3 Prior Lines of Therapy

Trial Profile

Phase I/II, First in Human, Dose Escalation Trial of the Bruton's Tyrosine Kinase Inhibitor M7583 in Patients With Relapsed/Refractory B Cell Malignancies and Expansion Cohorts in Patients With Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma (ABC Subtype) That Have Progressed After at Least 1 But Not More Than 3 Prior Lines of Therapy

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Jul 2017

At a glance

  • Drugs M 7583 (Primary)
  • Indications B cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Lymphoid leukaemia; Mantle-cell lymphoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors EMD Serono
  • Most Recent Events

    • 05 Jul 2017 Planned number of patients changed from 60 to 20.
    • 05 Jul 2017 Planned End Date changed from 30 Jun 2019 to 25 Oct 2019.
    • 05 Jul 2017 Planned primary completion date changed from 30 Jun 2019 to 25 Oct 2019.
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