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

STATUS

Recruiting
End date

Feb 28, 2024
participants needed

80
sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Send

Updated on 17 June 2021

See if I qualify

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.

Details

Condition	Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Treatment	TQ-B3525 tablets
Clinical Study Identifier	NCT04808570
Sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on	17 June 2021

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	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
	\. Has psychotropic substances abuse or a mental disorder

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study Definition