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

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

Official Title
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A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 in Subjects With Relapsed/Refractory Anaplastic Large Cell Lymphoma (ALCL)

Conditions
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Relapsed/Refractory Anaplastic Large Cell Lymphoma (ALCL)

Intervention / Treatment
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* Drug: TQ-B3101 capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQ-B3101<br>TQ-B3101 capsule administered orally. | Drug: TQ-B3101 capsule<br>* Escalating doses starting at 200 mg bid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | Percentage of subjects achieving complete response (CR) and partial response (PR) according to Lugano response criteria. | Baseline up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) within 2-year | 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. | Baseline up to 24 months | 
| Overall survival (OS) within 2-year | 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. | Baseline up to 24 months |