A Study of TQ-B3101 in Subjects With Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL)
Study Details
Study Description
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) .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TQ-B3101 TQ-B3101 capsule administered orally. |
Drug: TQ-B3101 capsule
Escalating doses starting at 200 mg bid.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TQ-B3101-II-02