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Completed

NCT Number: NCT04440059

A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R WM will be evaluated in approximately 44 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.

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Key information

Conditions

Waldenstrom's Macroglobulinemia Recurrent Waldenstrom's Macroglobulinemia Refractory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, 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:

  • Clinical and histologically confirmed giant globulinemia Fahrenheit (WM Ii International Working Group Standards, IWWM-2, 2003) (Owen et al., 2003)
  • At least one treatment indication is met (7th WM International Working Group standards, IWWM-7) (Dimopoulos et al., 2014)
  • With the lowest serum IgM value >2 times ULN as the efficacy evaluation index
  • ECOG physical strength score 0-2
  • Voluntary written informed consent prior to trial screening.

Key Exclusion Criteria:

  • Present or prior history of other malignant neoplasms, unless radical treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
  • Amyloidosis and central nervous system (CNS) involvement caused by WM
  • Demonstrate disease transformation
  • Patients who had received autologous stem cell transplantation within the previous 6 months
  • A history of organ transplantation or allogeneic bone marrow transplantation

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

Treatment and study plan

ICP-022

Drug

ICP-022 at a dose of 150mg PO QD

Primary outcomes

  1. Major response rate（MRR）

    Time frame: Up to 3 years

Secondary outcomes

  1. The occurrence of adverse events and serious adverse events

    Time frame: Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days.

    The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria

  2. Duration of Major Mitigation (DOMR)

    Time frame: Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.

  3. Progression Free Survival (PFS)

    Time frame: Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open Clinical Trial to Evaluate the Safety and Efficacy of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (WM)

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2020
Registry last updated
Apr 18, 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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