CompletedPhase 2

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

China47 participantsStarted 2019-08-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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.

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

What they're measuring

Major response rate（MRR）

Timeframe: Up to 3 years

Trial details

NCT IDNCT04440059

SponsorBeijing InnoCare Pharma Tech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-09

View on ClinicalTrials.gov More Waldenstrom's Macroglobulinemia Recurrent trials