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Study Summary
No. 2011-0319:.......Leukemia......Gautam Borthakur......Leukemia
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Study Summary Title
Study Summary
Number:
2011-0319
Study Title:Eltrombopag for the management of thrombocytopenia associated with tyrosine kinase therapy in patients with chronic myeloid leukemia (CML) and Myelofibrosis (MF)
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Physician New Patient Referral
Name:Gautam BorthakurPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1586
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:GlaxoSmithKline
Phase of Study:Phase II/Phase IIIReturn
Visit:
Treatment
Agents:
Eltrombopag Home Care:
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Description/
Intervention:
The goal of this clinical research study is learn if eltrombopag can help
control or prevent low platelet counts in patients receiving treatment for CML
or myelofibrosis.
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Study Objectives / Outcomes
Primary: To determine the efficacy of eltrombopag for patients with chronic myeloid leukemia (CML) or myelofibrosis (MF) who have developed thrombocytopenia during the course of therapy with tyrosine kinase inhibitors (TKI) as measured by recovery of platelet count.
Secondary:
1. To determine the safety of eltrombopag for patients with CML or MF who have developed thrombocytopenia during the course of therapy with TKI
2. To determine the dose intensity of TKI after start of therapy with eltrombopag
3. To determine response to TKI after start of therapy with eltrombopag
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Study Status Information
Study Activation / Registration Date:01/13/2012
IRB Review and Approval Date:01/13/2012
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) CML patients in chronic phase receiving treatment with any FDA approved TKI (imatinib, nilotinib, or dasatinib); or CML patients in accelerated or blastic phase who are considered to be in this phase because of thrombocytopenia or because of clonal evolution and with no other criteria for accelerated/blastic phase or patients with myelofibrosis receiving treatment with FDA approved TKI (ruxolitinib) and with peripheral blood and/or bone marrow blasts </= 10%.

2) Grade >/= 3 thrombocytopenia (platelets < 50 x 10^9/L) after the first 3 months of therapy with the TKI for patients with CML and platelets <100 x 10^9/L for patients with MF after the first 3 months of therapy. Thrombocytopenia must be either recurrent (i.e., second or greater episode of thrombocytopenia) or having required dose reductions of the TKI.

3) Subject is anticipated to have therapy with TKI continued for >/= 3 months

4) Adequate organ function: Total bilirubin (except for Gilbert's Syndrome) </= 1.5 x ULN; ALT and AST < 3 x ULN; Creatinine </= 2 x ULN

Exclusion Criteria:1) CML patients in accelerated or blastic phase except for those who are considered to be in this phase because of thrombocytopenia or because of clonal evolution and with no other criteria for accelerated/blastic phase; or myelofibrosis patients who have transformed to acute leukemia or have >/= 10% blasts in periperal blood and/or in bone marrow.

2) Thrombocytopenia that is considered to be unrelated to treatment with TKI or accelerated phase as defined above;

3) Age < 18 years;

4) Stem cell transplantation within preceding 60 days prior to registration;

5) Patients with documented active hepatitis B or C infection;

6) Patients with known bone marrow reticulin fibrosis (only applicable to patients with CML);

7) Patients with palpable splenomegaly >/= 16cm below coastal margin (only applicable to patients with CML).

8) Female subjects who are pregnant or breastfeeding. Women of childbearing potential are required to have a BHCG serum or urine pregnancy test performed within 7 days prior to first study drug dose. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.

9) Patients with known risk factors for thromboembolism (e.g. Factor V Leiden mutation, ATIII deficiency, Protein C and S deficiency, antiphospholipid syndrome, portal hypertension, etc.)

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Links
Registration Number: NCT01428635
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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