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TerminatedNCT04808570Updated Nov 29, 2023

A Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase 1/2 interventional study of TQ-B3525 tablets in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Terminated at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (part of Sino Biopharmaceutical Limited) · Phase 1/2, Interventional, and Treatment

Why this study was terminated
The sponsor terminated the study due to the R\&D strategy change.
Phase
Phase 1/2
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.

02

Conditions studied

  • Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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03

In context

Recurrence

4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.

This study's enrollment of 23 is below the median of 50 across 3,429 interventional studies indexed under Recurrence.

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Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 320 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1.Understood and signed an informed consent form; 2. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 2, Life expectancy ≥ 3 months; 3.Chronic lymphocytic leukemia/small lymphocytic lymphoma diagnosed by flow cytometry or pathology, and meets at least one of the criteria for active diseases requiring treatment in IWCLL2008; 4.Has received at least one line of previous treatment, the latest treatment confirmed no objective response, or disease progress after treatment; 5.Has at least one measurable lesion; 6. Adequate organ system function; 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.

Exclusion criteria

Exclusion Criteria:

-1. Has Richter's transformation or prolymphocytic leukemia (PLL); 2. Has central nervous system violation; 3. Has uncontrolled primary autoimmune cytopenias, including autoimmune hemolytic anemia (AIHA), idiopathic thrombocytopenic purpura (ITP), etc; 4. Has received other PI3K inhibitors or CAR-T treatments; 5. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 6.Diagnosed as type I diabetes or uncontrollable type II diabetes, or fasting blood glucose> 8.9 mmol/L or glycosylated hemoglobin (HbA1c)> 8.5% during the screening period; 7. Has interstitial lung disease or drug-induced interstitial lung disease history; 8. Has a history of immunodeficiency diseases; 9. Has multiple factors affecting oral medication; 10. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 11. Has received systemic steroid treatment within 7 days before the first administration; 12. Has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first; 13.Has active infections within 4 weeks before the first administration; 14.Has received surgery, or unhealed wounds within 4 weeks before the first administration; 15. Has a history of autologous hematopoietic stem cell transplant within 3 months; 16. Has a history of allogeneic hematopoietic stem cell transplant; 17. Grade II or higher cardiovascular disease within 6 months before the first administration; 18.QTCF > 480ms, LVEF \< 50%; 19.Urinary protein ≥ 2 +, and 24-hour urinary protein quantity>1g within 7 days; 20. Has active hepatitis B or C; 21. Has psychotropic substances abuse or a mental disorder; 22. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.

21. Has psychotropic substances abuse or a mental disorder;

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    TQ-B3525 tablets

    TQ-B3525 tablet administered orally.

    Drug: TQ-B3525 tablets

Interventions

  • TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.

06

What researchers measure

Primary outcomes

  1. Overall response rate (ORR) assessed by Independent Review Committee

    Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC

    Time frame: Baseline up to 18 months

Secondary outcomes

  1. Overall response rate (ORR) assessed by Investigator

    Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.

    Time frame: Baseline up to 18 months

  2. Duration of disease remission (DOR)

    The time from the first evaluation of the subject as CR or PR to the first evaluation of the subject as PD or death (whichever occurs first).

    Time frame: Baseline up to 18 months

  3. Progression-free survival (PFS)

    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

    Time frame: Baseline up to 18 months

  4. Disease control rate(DCR)

    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

    Time frame: Baseline up to 18 months

  5. Overall Survival (OS)

    OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.

    Time frame: Baseline up to 24 months

  6. Incidence of Adverse Events, Serious Adverse Events

    AE, SAE, and withdrawal from the trial for reasons such as safety or tolerability.

    Time frame: Baseline up to 18 months

07

Study locations

9 sites
  • The First Affiliate Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510120, China
  • Guangzhou First People's Hospital
    Guangzhou, Guangdong 510180, China
  • The First Affiliated Hospital of Guangxi Medical University
    Nanning, Guangxi 530021, China
  • The Affiliated Hospital of Guizhou Medical University
    Guiyang, Guizhou 550004, China
  • The Second Xiangya Hospital of Central South University
    Changsha, Hunan 410008, China
  • Jiangsu Province Hospital
    Nanjing, Jiangsu 210029, China
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin Municipality 300050, China
  • Hematology Hospital of Chinese Academy of Medical Sciences
    Tianjin, Tianjin Municipality, China
  • Tianjin Medical University Cancer Institute & Hospital
    Tianjin, Tianjin Municipality, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2021 to primary completion in Nov 2023, 29 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2021
First posted
Mar 22, 2021
StartActual
Jun 5, 2021
Primary completionActual
Nov 22, 2023
CompletionActual
Nov 22, 2023
Last update
Nov 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04808570
Responsible party
Sponsor
First posted
Mar 22, 2021
Start date
Jun 5, 2021
Primary completion
Nov 22, 2023
Completion
Nov 22, 2023
Last update
Nov 29, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: TQ-B3525

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