Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01168921
First received: July 22, 2010
Last updated: May 6, 2013
Last verified: May 2013
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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 Patients 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).
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | November 2014 (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:
- 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 </=2X upper limit normal (ULN); ALT </=2.5X 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168921
Contacts
| Contact: William G. Wierda, MD, PHD, BS | 713-745-0428 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| 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 |
| Study First Received: | July 22, 2010 |
| Last Updated: | May 6, 2013 |
| 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 Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Blood Platelet Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013