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

NCT ID: NCT04306887

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-29
• Study Completion Date: 2022-12-31

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) .

Conditions

Relapsed/Refractory Anaplastic Large Cell Lymphoma (ALCL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQ-B3101

TQ-B3101 capsule administered orally.

Group Type: EXPERIMENTAL

TQ-B3101 capsule

Intervention Type: DRUG

Escalating doses starting at 200 mg bid.

Interventions

TQ-B3101 capsule

Escalating doses starting at 200 mg bid.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huiqiang Huang

Role: CONTACT

huanghq@sysucc.org.cn

020-87343349

Facility Contacts

Huiqiang Huang

Role: primary

huanghq@sysucc.org.cn

020-87343349

Other Identifiers

TQ-B3101-II-02

Identifier Type: -

Identifier Source: org_study_id