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TL-895 + Navtemadlin for Chronic Lymphocytic Leukemia
Study Summary
This trial is testing a new drug, TL-895, to see if it is safe and tolerable for people with relapsed or refractory B cell malignancies who have failed one to three prior therapies. The trial has two parts; the first part has already completed testing and the second part is currently enrolling participants. The second part of the trial will test different doses of TL-895 on two groups of people: those who have failed at least one prior therapy, and those who have not received any prior therapy. Every participant in the study will receive TL-895.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My blood, liver, and kidney functions are all within normal ranges.I am not pregnant or breastfeeding.I have not received any treatment for my CLL or SLL.I can take care of myself but might not be able to do heavy physical work.My CLL/SLL has come back or didn't respond to treatment.I have had a major organ transplant.I have been treated with BTK or PI3K inhibitors before.
- Group 1: TL-895 150 mg BID in Treatment Naïve Participants
- Group 2: TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants with 17p(del)
- Group 3: TL-895 150 mg BID in R/R Participants
- Group 4: TL-895 100 mg BID in R/R Participants
- Group 5: TL-895 100 mg BID in Treatment Naïve Participants
- Group 6: TL-895 80/160 mg QD in R/R Participants
- Group 7: TL-895 300 mg QD in R/R Participants
- Group 8: TL-895 600 mg QD in R/R Participants
- Group 9: TL-895 300 mg BID in R/R Participants
- Group 10: TL-895 900 mg QD in R/R Participants
- Group 11: TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants without 17p(del)
- Group 12: TL-895 150 mg BID & navtemadlin 240mg QD in Treatment Naïve Participants without 17p(del)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there currently any opportunities to join this clinical research?
"Currently, the clinical trial in question is not enlisting new participants. This medical study was created on August 26th 2016 and last modified October 11th 2022. Despite this, there are still 5077 other trials seeking enrolment right now."
What objectives are being pursued through this research endeavor?
"This ongoing study is attempting to evaluate the Dose Limiting Toxicities (DLTs) during Cycle 1. Secondary objectives include tracking Treatment-Emergent Adverse Events (TEAEs), Best Overall Response (BOR)/Progression Free Survival (PFS), and Duration of Clinical Response (DOR). These results will be monitored from Baseline up until two years after recruitment has concluded."
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