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Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01168921
First received: July 22, 2010
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
CLL
Leukemia
Drug: Eltrombopag
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Eltrombopag for Patients With Chronic Lymphocytic Leukemia (CLL) and Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Participants with Overall Response [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Overall response rate (OR), which is defined as the composite of complete response (CR) and major response (MR). CR is defined as an increase in platelets (PLT) count to ≥100K/µL for at least 4 weeks. MR is defined as an increase in PLT count from <20K/µL to ≥20K/µL and by at least 100% for at least 8 weeks; or for participants starting with >20K/µL platelets, absolute increase in PLT count of ≥30K/µL for at least 4 weeks: or PLT transfusion independence (no PLT transfusion) for at least 4 weeks. Overall response is best response achieved over first 3 months of treatment.


Estimated Enrollment: 36
Study Start Date: November 2010
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eltrombopag
Starting dose 75 mg by mouth (PO) daily for 28 day cycle.
Drug: Eltrombopag
Starting dose 75 mg by mouth (PO) daily for 28 day cycle
Other Name: Promacta

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
  2. Age >/= 18 years
  3. 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
  4. Patients with ITP must have failed at least 1 prior treatment for ITP including one of the following: corticosteroids, rituximab, splenectomy, cyclosporine
  5. At least 3 weeks must have elapsed since the last chemotherapy treatment for CLL
  6. ECOG performance status (PS) </=2
  7. Adequate liver function (total bilirubin </=2* upper limit normal (ULN); ALT </=2.5* ULN)
  8. Adequate renal function (serum creatinine Cr </=2.2 mg/dL)
  9. 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
  10. Able to provide informed consent

Exclusion Criteria:

  1. Concurrent chemotherapy for CLL
  2. Diagnosis of Richter's transformation
  3. 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.
  4. Concurrent treatment for ITP (except for corticosteroids and cyclosporine)
  5. Diagnosis of myelodysplastic syndrome or acute myeloid leukemia
  6. Active infection or significant medical illness as determined by the treating physician
  7. Treatment with thrombomimetic agents in the past 3 months (rTPO, PEG-rHuMGDF, Nplate or Promacta)
  8. Pregnant or breast feeding subjects and subjects not willing to use adequate contraceptive precautions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168921

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
GlaxoSmithKline
Investigators
Study Chair: William G. Wierda, MD, PHD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01168921     History of Changes
Other Study ID Numbers: 2010-0123, NCI-2012-01905
Study First Received: July 22, 2010
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
CLL
Thrombocytopenia
Small lymphocytic lymphoma
SLL
Eltrombopag
Promacta
thrombopoietin (TPO)-receptor agonist
platelets

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 23, 2014