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Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.

Multiple Myeloma Clinical Trial

Official title:
A Phase 1/1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of LP-118 in Subjects With Relapsed or Refractory Hematological Malignancies

Clinical Trial Summary

This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing schedule in up to 100 subjects.

Clinical Trial 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 (low risk tumor lysis) CLL/SLL (Group 1a); relapsed/refractory MF, CMML-2, MDS/MPN, MDS-BP, MDS; AML with WBC ≤ 25 × 10^9 cells/L (Group 1b); relapsed/refractory NHL, RT, MM, T-PLL (Group 1c); relapsed/refractory ALL (Group 1d); relapsed/refractory (intermediate and high tumor lysis risk) CLL/SLL, NHL, RT, T-PLL (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 (low risk tumor lysis) CLL/SLL (Group 1a); relapsed/refractory MF, CMML-2, MDS/MPN, MDS-BP, MDS; AML with WBC ≤ 25 × 10^9 cells/L (Group 1b); relapsed/refractory NHL, RT, MM, T-PLL (Group 1c); relapsed/refractory ALL (Group 1d); relapsed/refractory (intermediate and high tumor lysis risk) CLL/SLL, NHL, RT, T-PLL (Group 2); ;

Study Design

Related Conditions & MeSH terms

  • Acute Lymphocytic Leukemia
  • Acute Myeloid Leukemia
  • Blast Crisis
  • Chronic Lymphocytic Leukemia
  • Chronic Myelomonocytic Leukemia-2
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelomonocytic, Juvenile
  • Leukemia, Prolymphocytic
  • Leukemia, Prolymphocytic, T-Cell
  • Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Myelodysplastic-Myeloproliferative Diseases
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Myelofibrosis
  • Myeloproliferative Disorders
  • Myeodysplastic Syndrome
  • Neoplasms
  • Non Hodgkin Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Richter Transformation
  • Small Lymphocytic Lymphoma
  • T-cell-prolymphocytic Leukemia
Clinical Trial Details
NCT number NCT04771572
Study type Interventional
Source Newave Pharmaceutical Inc
Contact Anna Chen, MD, PhD
Phone (206) 335-3820
Email yu@newavepharma.com
Status Recruiting
Phase Phase 1
Start date August 23, 2021
Completion date October 1, 2025
View Details
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