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A Combined Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of TP-0903 in Patients with Previously Treated Chronic Lymphocytic Leukemia (CLL)

Clinical Trial Details

This clinical trial is for men and women age 18 and older with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 

This is a combined Phase 1/2 study of oral TP-0903 in patients with previously treated CLL/SLL to characterize the safety and toxicity profile of TP-0903 and to determine the recommended phase 2 dose. In both Phase 1 and Phase 2, study participants will be assigned to one of two defined patient groups: Monotherapy and combination therapy. Both groups of patients will be treated identically with TP-0903 and will undergo the same study assessments. 

Group 1 (TP-0903 monotherapy): Patients with CLL/SLL who are intolerant to, or have progressed on, B-cell receptor antagonists and/or BCL-2 antagonists 

Group 2 (TP-0903 and ibrutinib combination therapy): Patients with CLL/SLL who have progressed on ibrutinib yet the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patie 

TP-0903 is an oral inhibitor that targets and binds to AXL kinase and prevents tumor cell proliferation. TP-0903 will be administered orally once daily for 28 days. Participants will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. 

Key Eligibility: 
  • Women and men age 18 and older. 
  • Pathologically confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) 
  • Have received at least one prior therapy for CLL/SLL 
  • Detailed eligibility reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amelyn Rodriguez, RN, NP
(212) 746-1362
amr2017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1807019436

ClinicalTrials.gov:

NCT03572634

Status

Not Yet Recruiting

Age Group

Adult

Sponsor