Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Blood Cancer
- Diffuse Large B Cell Lymphoma
- Hematological Malignancy
- Leukemia Lymphocytic Chronic B-Cell
- Non-Hodgkin's B-cell Lymphoma
- Small Lymphocytic Leukemia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a three-part Phase 2 study Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 [Completed] Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 in the MTD Expansion Cohort. Part 3: (Phase 2 MTD Expansion Cohort) Determine t...
This is a three-part Phase 2 study Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 [Completed] Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 in the MTD Expansion Cohort. Part 3: (Phase 2 MTD Expansion Cohort) Determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the overall response rate (ORR) by the revised Lugano Classification for Lymphoma adjusted according to LYRIC. It is anticipated that up to 100 patients will be enrolled in Part 3. Treatment will continue for up to six 21 days cycles. If the subject exhibits SD, CR or PR after the end of Cycle 6 and the investigator determines that the benefit-risk ratio is favorable, then the treatment with MT-3724 may be continued after discussion with the sponsor.
Tracking Information
- NCT #
- NCT02361346
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon