A Study of TQ-B3101 in Subjects With Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL)

Phase 2

• Conditions: Relapsed/Refractory Anaplastic Large Cell Lymphoma (ALCL)
• Interventions: Drug: TQ-B3101 capsule

• Registration Number: NCT04306887
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary

The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with relapsed/refractory anaplastic large cell lymphoma (ALCL) .

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-29
• Status Verified: 2020-03
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-13
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-1.Female or male, 10 years and older. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. 3.Histologically or cytologically confirmed ALK positive relapsed or refractory Anaplastic Large Cell Lymphoma.

4.At least one measurable lesion. 5.Life expectancy ≥ 3 months. 6.Adequate organ system function. 7.Understood and signed an informed consent form.

Exclusion Criteria

• 1.Primary cutaneous anaplastic large cell lymphoma. 2.Other malignancies occurred within 5 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors.

  3.Has received ALK inhibitor. 4.Has received an allogeneic stem cell transplant. 5.Has received autologous stem cell transplant within 12 weeks before the first administration.

  6.Has received other anti-tumor medications within 4 weeks of the first administration.

  7.Has received major surgery within 4 weeks before the first administration. 8.Has received any curative radiotherapy or minor surgery within 2 weeks before the first administration.

  9.Has received palliative radiation therapy within 2 days before the first administration.

  10.Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

  11.Has uncontrollable congestive heart failure. 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TQ-B3101	TQ-B3101 capsule	TQ-B3101 capsule administered orally.

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	Baseline up to 18 months	Percentage of subjects achieving complete response (CR) and partial response (PR) according to Lugano response criteria.

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS) within 2-year	Baseline up to 24 months	PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
Overall survival (OS) within 2-year	Baseline up to 24 months	OS was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China