---
title: A Study of TQ-B3101 in Subjects With Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL)
nct_id: NCT04306887
overall_status: UNKNOWN
phase: PHASE2
sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Relapsed/Refractory Anaplastic Large Cell Lymphoma (ALCL)
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04306887.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04306887"
ct_last_update_post_date: 2020-03-13
last_seen_at: "2026-05-12T07:25:48.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of TQ-B3101 in Subjects With Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL)

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

**NCT ID:** [NCT04306887](https://clinicaltrials.gov/study/NCT04306887)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- **Conditions:** Relapsed/Refractory Anaplastic Large Cell Lymphoma (ALCL)
- **Start Date:** 2019-11-29
- **Completion Date:** 2022-12-31
- **CT.gov Last Update:** 2020-03-13

## 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) .

## Eligibility

- **Minimum age:** 10 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **TQ-B3101** (EXPERIMENTAL) — TQ-B3101 capsule administered orally.

## Interventions

- **TQ-B3101 capsule** (DRUG) — Escalating doses starting at 200 mg bid.

## Primary Outcomes

- **Overall response rate (ORR)** _(time frame: Baseline up to 18 months)_ — Percentage of subjects achieving complete response (CR) and partial response (PR) according to Lugano response criteria.

## Secondary Outcomes

- **Progression free survival (PFS) within 2-year** _(time frame: Baseline up to 24 months)_
- **Overall survival (OS) within 2-year** _(time frame: Baseline up to 24 months)_

## Locations (1)

- Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sun yat-sen university cancer center|guangzhou|guangdong|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04306887.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04306887*  
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