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Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaPhase 1/2NCT04808570

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

A Phase 1/2 study testing TQ-B3525 tablets in people with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TQ-B3525 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
9 sitesChina
Study dates
5 Jun 2021to 22 Nov 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • -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;

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • The First Affiliate Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300050

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: A Single-arm, Open-label, Multi-center Phase Ib/II Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma(CLL/SLL)

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

Being tested
TQ-B3525 tablets
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQ-B3525 tabletsDrug

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

Study groups in NCT04808570
Study groupRoleWhat they receive
TQ-B3525 tabletsExperimentalTQ-B3525 tablet administered orally.
Receives: Drug: TQ-B3525 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline up to 18 months

Secondary outcomes (6)

  1. Overall response rate (ORR) assessed by Investigator

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

    Measured: 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).

    Measured: 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

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: Baseline up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study start5 Jun 2021
  3. Primary completion22 Nov 2023
  4. Study completion22 Nov 2023

Why it stopped: The sponsor terminated the study due to the R\&D strategy change.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04808570
Sponsor's protocol ID
TQ-B3525-Ib/II-06
Status last verified
Oct 2023
First submitted
11 Mar 2021
Last updated
29 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQ-B3525 tablets in people with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The sponsor terminated the study due to the R\&D strategy change.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) assessed by Independent Review Committee (time frame: Baseline up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04808570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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