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Recruiting NCT07082686

A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)

Phase II Interventional Relapsed or Refractory Mantle Cell Lymphoma (MCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICP-248.
Who it may be relevant to
Registry conditions: Relapsed or Refractory Mantle Cell Lymphoma (MCL). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-arm, Multi-center, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Overview

This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.

Interventions

  • Drug ICP-248
    Eligible patients will receive ICP-248 orally as per the protocol

Primary outcome measures

  • Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC) [Time frame: 3 years]
Secondary outcome measures (12)
  • According to Lugano 2014: IRC and investigator assessed complete response rate (CRR) [Time frame: 3 years]
  • Investigator-assessed ORR [Time frame: 3 years]
  • According to Lugano 2014: IRC and investigator assessed disease control rate (DCR). [Time frame: 3 years]
  • According to Lugano 2014: IRC and investigator assessed duration of response (DOR). [Time frame: 3 years]
  • According to Lugano 2014: IRC and investigator assessed time to initial response (TTR). [Time frame: 3 years]
  • According to Lugano 2014: IRC and investigator assessed progression-free survival (PFS) . [Time frame: 3 years]
  • Overall survival (OS) [Time frame: 3 years]
  • Adverse event (AE) assessed according to CTCAE v5.0 criteria [Time frame: 3 years]
  • Functional Assessment Of Cancer Therapy-Lymphoma (Fact-Lym) and European Quality Of Life Five Dimension Five Level Scale Questionnaire (Eq-5D-5L). [Time frame: 3 years]
  • Area under the plasma concentration versus time curve (AUC) [Time frame: 3 years]
  • minimal residual disease （MRD） status [Time frame: 3 years]
  • Peak Plasma Concentration (Cmax) [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • ≥ 18 years old.
  • Histopathologically confirmed MCL expressing Cyclin D1 and/or t (11;14) chromosomal translocation.Formalin-fixed paraffin-embedded (FFPE) tissues or sections for diagnosis must be provided. It is for the approval of pathological diagnosis by the central pathology laboratory.
  • The patient was diagnosed with relapsed or refractory mantle cell lymphoma, and the previous treatment needs to meet the following requirements:
  • Failure of at least one adequate prior line of anti-CD20-containing therapy;
  • Failure of at least one adequate prior line of BTK inhibitor (BTKi)-containing therapy.
  • Failure of the last line of therapy.
  • At least one measurable lesion according to the Lugano 2014 criteria,.
  • ECOG performance status of 0-2 .

Exclusion criteria

  • Current or prior history of central nervous system (CNS) lymphoma.
  • Prior use of BCL-2 inhibitors (e.g., venetoclax/ABT-199, etc.).
  • Autologous stem cell transplantation or cellular therapy within 3 months prior to the first dose of ICP-248.
  • Prior allogeneic hematopoietic stem cell transplantation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 29 centers
  • The First Affiliated Hospital of Anhui Medical University — Hefei
  • Peking University Third Hospital — Beijing
  • West China Hospital of Sichuan University — Chengdu
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • Chongqing University Cancer Hospital — Chongqing
  • Fujian Medical University Union Hospital — Fuzhou
  • Sun Yat-sen University Cancer Center — Guangzhou
  • Guangdong Provincial People's Hospital — Guangzhou
  • … and 21 more centers

Identifiers

NCT: NCT07082686 · ICP-CL-01206

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗