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Phase I/II, First in Human, Dose Escalation Trial of TL 895 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Small Lymphocytic Lymphoma

NCT02825836

Description:

The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants. Part 2 of this study will test different doses of TL-895 in participants with R/R CLL or SLL who have failed at least 1 prior therapy. Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day. Every participant in this study will receive TL-895.

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Mantle Cell Lymphoma
  • Small Lymphocytic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase I/II, First in Human, Dose Escalation Trial of TL 895 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Small Lymphocytic Lymphoma
  • Official Title: Phase I/II, First in Human, Dose Escalation Trial of TL 895 in Subjects With Relapsed/Refractory B-Cell Malignancies and Expansion in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Small Lymphocytic Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: MS200662_0001
  • SECONDARY ID: 2016-000286-23
  • NCT ID: NCT02825836

Conditions

  • Relapsed/Refractory B Cell Malignancies
  • Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Interventions

DrugSynonymsArms
TL-895TL-895 100 mg BID

Purpose

The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants. Part 2 of this study will test different doses of TL-895 in participants with R/R CLL or SLL who have failed at least 1 prior therapy. Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day. Every participant in this study will receive TL-895.

Trial Arms

NameTypeDescriptionInterventions
TL-895 80/160 mg QDExperimentalParticipants received TL-895 80 mg powder in capsule (PiC) orally once daily (OD) for 3 days followed by TL-895 160 mg OD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
  • TL-895
TL-895 300 mg QDExperimentalParticipants received TL-895 300 mg PiC orally OD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
  • TL-895
TL-895 600 mg QDExperimentalParticipants received TL-895 600 mg PiC orally OD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
  • TL-895
TL-895 300 mg BIDExperimentalParticipants received TL-895 300 mg PiC orally twice daily (BID) in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
  • TL-895
TL-895 900 mg QDExperimentalParticipants received TL-895 900 mg PiC orally QD in fasted state for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
  • TL-895
TL-895 100 mg BIDExperimentalParticipants received TL-895 100 mg BID orally BID with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
  • TL-895
TL-895 150 mg BIDExperimentalParticipants received TL-895 150 mg BID orally BID with food for 28 days in each 28 day cycle until disease progression, withdrawal of consent, or discontinuation from the study.
  • TL-895

Eligibility Criteria

        Inclusion Criteria

          -  Relapsed/refractory CLL or relapsed/refractory SLL

          -  ECOG performance status of ≤ 2

          -  Adequate hematologic, hepatic, and renal functions

        Exclusion Criteria

          -  Prior treatment with any BTK or PI3K inhibitors

          -  History of major organ transplant

          -  Women who are pregnant or breastfeeding
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1 (Dose Escalation): DLTs (Dose Limiting Toxicities) during Cycle 1
Time Frame:Baseline up to the end of cycle 1 (28 days)
Safety Issue:
Description:DLT is defined as any of the adverse event (AEs) of a certain grade or above, related to drug.

Secondary Outcome Measures

Measure:Part 1 (Dose Escalation): Best Overall Response (BOR)/Progression Free Survival (PFS)
Time Frame:Baseline up to 6 months on treatment
Safety Issue:
Description:Defined by the length of time during the treatment of the disease, that a participant lives with the disease but it does not get worse based on investigator assessments
Measure:Part 2 (Dose Expansion): Overall CR/CRi rate
Time Frame:Baseline up to end of study (2 years after last patient enrolled)
Safety Issue:
Description:The proportion of subjects achieving CR/CRi based on iwCLL response criteria
Measure:Part 2: Duration of Clinical Response (DOR)
Time Frame:Baseline up to end of study (2 years after last patient enrolled)
Safety Issue:
Description:Time from initial response to disease progression or death from any cause
Measure:Part 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame:Baseline up to end of study (2 years after last patient enrolled)
Safety Issue:
Description:Incidence, nature, severity of treatment-emergent adverse events (TEAEs), and deaths, including cause of death, from screening up to the end of study visit of participants with CLL/SLL who have failed at least 1 line of therapy
Measure:Part 2: Assessment of Safety and Tolerability via Clinical Measurements
Time Frame:Baseline up to end of study (2 years after last patient enrolled)
Safety Issue:
Description:Assessments including but not limited to clinical laboratory measurements, ECGs, vital signs, and ECOG performance

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Telios Pharma, Inc.

Trial Keywords

  • TL-895
  • Tyrosine Kinase Inhibitor
  • Lymphoma
  • Open
  • Phase I
  • Phase II
  • CLL
  • SLL

Last Updated

May 12, 2021