Status:
COMPLETED
Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia.
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II multicentre study. Patients will be administered eltrombopag 50 mg/daily. If patients don't achieve response after 2 months of therapy they will stop eltrombopag; if patients will a...
Detailed Description
The incidence of delayed thrombocytopenia in patients who undergo allogeneic hemopoietic stem cell transplant (SCT) is nearly 20-40% (1-2). Chronic graft versus host disease (cGVHD) seems to be the mo...
Eligibility Criteria
Inclusion
- Patients develop delayed thrombocytopenia, i.e. Platelet count 50 x 109/l 3 months after SCT;
- Patients underwent allogeneic SCT with match related or unrelated donor;
- Patients develop CGVHD-related delayed thrombocytopenia. The definition of cGVHD-related delayed thrombocytopenia is: platelet count 50 x 109/l from month 3 from SCT and presence of any clinical, radiological and/or laboratory finding indicative of cGVHD (all grades); - Patients underwent SCT because of lymphoma (Hodgkin or non-Hodgkin, indolent or aggressive), or multiple myeloma;
- Sexually active males who accept to use a condom during intercourse while taking the drug and for 12 months after stopping treatment as they should not father a child in this period. A condom is required to be used also by vasectomised men (as well as during intercourse with a male partner) in order to prevent delivery of the drug via seminal fluid. Refer also to Appendix C. Female subjects of non-childbearing potential may be enrolled in the study; For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause (please refer to Appendix C);
- OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to start of eltrombopag, has a negative pregnancy test prior to start of eltrombopag, and has agreed to continue adequate contraception during the entire treatment period and for 6 months after completion of the treatment.
- Written informed consent obtained from the subject.
Exclusion
- Patients underwent SCT with aplo-identical donor or cord blood;
- Patients underwent SCT for diseases different from lymphoma or multiple myeloma;
- Patients have life threatening bleeding complications;
- Patients have an expected survival \< 1 month;
- Patients have delayed thrombocytopenia related to medical conditions other then cGVHD;
- Patients have progressive non stabilized cGVHD necessitating intensification of immune suppressive treatment in the last 2 weeks;
- Patients need to introduce or increase the dosage of steroids, any other immune suppressive or cytotoxic agent at the time of enrolment into the study or start of eltrombopag; patients already in treatment with a fixed, stabilized dosage of steroids or other immune suppressive agents because of cGVHD may be included into the study;
- Patients received concomitant erythropoietin treatment; Patients have active deep venous thrombosis (DVT);
- Patients have venous occlusive disease (VOD);
- Patients have grade 3-4 hyper bilirubinemia; elevation of hepatic enzymes because of cGVHD should not be considered criteria of exclusion.
- Patients with baseline elevation of hepatic enzymes will be monitored carefully in order to point out possible addictive eltrombopag- related hepatotoxicity;
- Patients have hepatic cirrhosis;
- Patients have transplant related-microangiopathy;
- Patients have active infections (CMV reactivation included);
- Patients have hypersensitive to study drug;
- Patients are unable to stop medications that are known to cause a drug-drug interaction with eltrombopag.
Key Trial Info
Start Date :
September 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01791101
Start Date
September 16 2013
End Date
June 26 2020
Last Update
June 11 2021
Active Locations (16)
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1
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari, Italy
2
Divisione di Ematologia - Ospedali Riuniti
Bergamo, Italy
3
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
Brescia, Italy
4
Ospedale Santa Croce Divisione di Ematologia Cuneo
Catania, Italy