Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)

NCT01168921 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2010-0123NCI-2012-01905
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if eltrombopag can help to increase the number of platelets in patients with CLL. The safety of this drug will also be studied.

Conditions

CLL; Leukemia

Keywords

Chronic Lymphocytic Leukemia; CLL; Thrombocytopenia; Small lymphocytic lymphoma; SLL; Eltrombopag; Promacta; thrombopoietin (TPO)-receptor agonist; platelets

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Response

  Response is Complete Response (CR) + Major Response (MR). Complete response was defined as an increase in platelet count to ≥100K/µL for at least 4 weeks. Major response was defined as an increase in platelet count from \<20K/µL to ≥20K/μL and by at least 100% for at least 8 weeks; or for pts starting with \>20K/μL platelet count, absolute increase in platelet count of ≥30K/μL for at least 4 weeks.

  Up to 4 years

Secondary Outcomes (1)

• Time to CLL Progression Requiring Leukemia Treatment

  Up to 4 years

Study Arms (1)

Eltrombopag

EXPERIMENTAL

Starting dose 75 mg by mouth (PO) daily for 28 day cycle.

Drug: Eltrombopag

Interventions

Eltrombopag DRUG

Starting dose 75 mg by mouth (PO) daily for 28 day cycle

Also known as: Promacta

Eltrombopag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
• Age \>/= 18 years
• PLT transfusion-dependent, defined as need for transfusion to maintain PLT count \>/=20K/µL, or the average of two (non-transfused) PLT counts taken within 2 weeks of the screening period \</=50K/µL, with no individual count \>55K/µL
• Patients with ITP must have failed at least 1 prior treatment for ITP including one of the following: corticosteroids, rituximab, splenectomy, cyclosporine
• At least 3 weeks must have elapsed since the last chemotherapy treatment for CLL
• ECOG performance status (PS) \</=2
• Adequate liver function (total bilirubin \</=2\* upper limit normal (ULN); ALT \</=2.5\* ULN)
• Adequate renal function (serum creatinine Cr \</=2.2 mg/dL)
• For patients with ITP on corticosteroids or cyclosporine, dose of corticosteroids or cyclosporine must be stable for 2 weeks prior to enrollment and planned to be tapered in patients responding to eltrombopag
• Able to provide informed consent

You may not qualify if:

• Concurrent chemotherapy for CLL
• Diagnosis of Richter's transformation
• Uncontrolled autoimmune hemolytic anemia i.e. patients with AIHA that is not controlled with treatment such as corticosteroids or cyclosporine. This would include patients who require PBRC transfusions or who do not have a stable hemoglobin (HGB) due to ongoing hemolysis.
• Concurrent treatment for ITP (except for corticosteroids and cyclosporine)
• Diagnosis of myelodysplastic syndrome or acute myeloid leukemia
• Active infection or significant medical illness as determined by the treating physician
• Treatment with thrombomimetic agents in the past 3 months (rTPO, PEG-rHuMGDF, Nplate or Promacta)
• Pregnant or breast feeding subjects and subjects not willing to use adequate contraceptive precautions

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Thrombocytopenia; Jacobs syndrome

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Platelet Disorders; Cytopenia

Results Point of Contact

• Title: William Wierda MD/Professor
• Organization: The University of Texas MD Anderson Cancer Center

wwierda@mdanderson.org

713-745-0428

Study Officials

• William G. Wierda, MD, PHD, BS

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 23, 2010
• Study Start: November 3, 2010
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: March 23, 2023
• Results First Posted: March 23, 2023

Record last verified: 2023-02

Locations

US (1)