Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory NHL, RT, MM, T-PLL, Acute Leukemia (AML, ALL), MDS, MDS/MPN, and MF
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphocytic Leukemia
- Acute Myeloid Leukemia
- MDS/MPN
- Multiple Myeloma
- Myelofibrosis
- Myeodysplastic Syndrome
- Non Hodgkin Lymphoma
- Richter Transformation
- T-Cell Prolymphocytic Leukemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The study will start at lower doses (10 mg, 20 mg) and adopt an "accelerated titration" design for these cohorts. Once the safety of the 20 mg dose level is established, we will continue dose escalation using a classic "3+3" design to establish DLT, MTD, and RP2D, starting also with an accelerated step-up dosing schedule.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary objectives of the study are to assess the safety and tolerability profile, determine the maximum tolerated dose (MTD), and/or the recommended Phase 2 dose (RP2D) of LP-118 administered once daily (QD) as a single agent dosed orally in adult subjects with relapsed/refractory NHL, RT, MM, T-PL...
Primary objectives of the study are to assess the safety and tolerability profile, determine the maximum tolerated dose (MTD), and/or the recommended Phase 2 dose (RP2D) of LP-118 administered once daily (QD) as a single agent dosed orally in adult subjects with relapsed/refractory NHL, RT, MM, T-PLL (Group 1) and acute leukemia (AML, ALL), MDS, MDS/MPN, MF (Group 2). Secondary objectives of the study are to evaluate preliminary efficacy regarding the effect of LP-118 on objective response rate (ORR) using disease specific response criteria, progression-free survival (PFS), and duration of response (DOR), and overall survival (OS) in adult subjects with relapsed/refractory NHL, RT, MM, T-PLL (Group 1); and acute leukemia (AML, ALL), MDS, MDS/MPN, MF (Group 2
Tracking Information
- NCT #
- NCT04771572
- Collaborators
- Not Provided
- Investigators
- Not Provided
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