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Completed

NCT Number: NCT04438005

A Study of ICP-022 in Patients With R/R DLBCL

It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.

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Key information

Conditions

Diffuse Large B Cell Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University Third Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion criteria：

  • Men and women between 18 and 75 years old,
  • Histologically confirmed diffuse large B-cell lymphoma（DLBCL）with MyD88 L265P and CD79B positive, at least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI,
  • ECOG performance status of 0-2,
  • Voluntary written informed consent prior to trail screening.

Key Exclusion criteria:

  • History of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry
  • History of Richter's syndrome
  • Current or history of lymphoma involved central nervous system
  • Prior corticosteroids (at dosages equivalent to prednisone > 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody based therapies or anti-cancer TCM within 4 weeks of the start of study drug.
  • The investigator considers other conditions unsuitable for this study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

ICP-022

Drug

ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.

Primary outcomes

  1. Overall response rate（ORR）

    Time frame: Up to 3 years

    The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL

Secondary outcomes

  1. Occurrence of adverse events and serious adverse events

    Time frame: Up to 3 years

    The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria

  2. Progression free survival（PFS）

    Time frame: Up to 3 years

    The efficacy measured by progression free survival（PFS）

  3. Duration of response（DOR）

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-Label Study to Investigate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Acronym: DLBCL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2020
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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