Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Open Label Multicenter Study of Eltrombopag for the Treatment of Immune ThrombocytoPenia (ITP) Secondary to Chronic Lymphoproliferative Disorders (LPDs)
NCT number | NCT01610180 |
Other study ID # | VI-Plt-01 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2012 |
Est. completion date | June 30, 2018 |
Verified date | July 2018 |
Source | Fondazione Progetto Ematologia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
With conventional treatments (i.e. iv Ig, steroids) the overall response rate of ITP
secondary to LPD is generally lower than in primary ITP, and usually not higher than 50% (95%
CI 27-72). Eltrombopag which has proved very effective in primary ITP could be effective also
in ITP secondary to LPDs.
This novel ITP specific treatment might spare these patients not only from bleeding risk but
also from toxic or inappropriate cytotoxic therapies, not otherwise demanded by the burden of
the underlying disease.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Diagnosis of any of the following B-cell chronic LPD, as defined by WHO 2008 classification: small lymphocytic lymphoma/chronic lymphocytic leukemia, follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, lymphoplasmacytic lymphoma, hairy cell leukemia, Hodgkin's lymphoma. 2. Occurrence of ITP diagnosed on the basis of predefined criteria. 3. Not likely to necessitate any cytotoxic treatment for the following 6 months, according to clinical stage and performance status. 4. Platelet count less than 30,000/µL; patients with platelet count between 30 and 50,000/µL only in case of bleeding signs or symptoms. 5. Age greater than or equal to 18 years. 6. Absence of a personal or family (up to first degree relatives) history of venous or arterial thromboembolism. 7. ECOG performance status =2. 8. Adequate liver and renal function. 9. Absence of active Hepatitis B (HBsAg+ or HBV-DNA+), Hepatitis C (HCV-Ab+), or HIV infection. 9) Provided informed consent. 10) Negative pregnancy test or lactation 11) No antiplatelet or anticoagulant ongoing treatments Exclusion Criteria: 1. Subjects with any clinically relevant abnormality, other than LPD or ITP, or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study. 2. Subjects with any concurrent malignant disease other that the LPD and/or a recent history of cancer treatment with systemic chemotherapy and/or radiotherapy. Exception: Subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. 3. Subjects with screening bone marrow fibers of either MF Grade 3 using European Consensus scale or Grade 4 using Bauermeister scale (see Appendix 1). 4. Subjects with a QTc >450 msec or > 480 msec for subjects with Bundle Branch Block. 5. Subjects with recent history of alcohol/drug abuse as determined by the investigator. |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Hematology, Ospedale San Bortolo | Vicenza |
Lead Sponsor | Collaborator |
---|---|
Fondazione Progetto Ematologia |
Italy,
Visco C, Maura F, Tuana G, Agnelli L, Lionetti M, Fabris S, Novella E, Giaretta I, Reda G, Barcellini W, Baldini L, Neri A, Rodeghiero F, Cortelezzi A. Immune thrombocytopenia in patients with chronic lymphocytic leukemia is associated with stereotyped B-cell receptors. Clin Cancer Res. 2012 Apr 1;18(7):1870-8. doi: 10.1158/1078-0432.CCR-11-3019. Epub 2012 Feb 9. — View Citation
Visco C, Rodeghiero F. Immune thrombocytopenia in lymphoproliferative disorders. Hematol Oncol Clin North Am. 2009 Dec;23(6):1261-74. doi: 10.1016/j.hoc.2009.08.006. Review. — View Citation
Visco C, Ruggeri M, Laura Evangelista M, Stasi R, Zanotti R, Giaretta I, Ambrosetti A, Madeo D, Pizzolo G, Rodeghiero F. Impact of immune thrombocytopenia on the clinical course of chronic lymphocytic leukemia. Blood. 2008 Feb 1;111(3):1110-6. Epub 2007 Nov 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of responders to eltrombopag as defined by changes in the platelet count, in platelet transfusion requirements and/or in the bleeding symptoms during the 6 months of treatment. | Response criteria according to the International Working Group publication (Rodeghiero et al, Blood 2009). | 6 months of treatment for each patient | |
Secondary | Assessment of the safety profile of eltrombopag in patients with LPD using the CTCAE criteria. | Adverse event reports graded with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 and laboratory assessments at each on-treatment and post-treatment visit. Physical examination, general laboratory tests, including liver function tests, blood cell count and peripheral blood smear examination, flow cytometry at scheduled visits. Bone marrow biopsy, CT scan of the neck, chest and abdomen at enrollment, if not already done in the three preceding months, at the end of study and 3 months thereafter. | 9 months | |
Secondary | Number of patients meeting permanent discontinuation criteria | The following permanent discontinuation criteria were applied during the study and extension period: failure to respond; progression of the underlying disease demanding treatment; drug related toxicity or any adverse events = grade 3 or peripheral blood and/or bone marrow findings suggesting marrow fibrosis (grade 3 or 4 of Bauermaister scale) or myelodisplasia or myeloproliferation including an increment of CD4 positive cell > 3 %. | From enrollment to end of study duration (24 weeks) and of extension phase (up to 5 years after first patient enrollment) |
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