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Eltrombopag for the Treatment of Immune ThrombocytoPenia (ITP) Secondary to Chronic Lymphoproliferative Disorders (LPDs)

NCT01610180 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-07-16

No results posted yet for this study

Summary

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.

Conditions

  • Purpura, Thrombocytopenic, Idiopathic
  • Autoimmune Thrombocytopenic Purpura
  • Autoimmune Thrombocytopenia
  • Chronic Lymphocytic Leukemia
  • Non Hodgkin's Lymphoma

Interventions

DRUG

Eltrombopag Olamine

Initial dose : 50 mg/day for 14 days. Next doses: 1. If platelet count \<60000/µL, increase daily dose by 25 mg to a maximum of 150 mg/day for next 14 days in 14 days courses. If response criteria not met after 14 days of the maximum dose stop treatment (no response). 2. If platelet count \>60000/µL and ≤200000/µL same dose for the next 14 days. 3. If platelet count \>200000/µL and ≤400000/µL decrease the daily dose by 25 mg. Wait 14 days to assess the effects of this and any subsequent dose adjustments. 4. If platelet count \>400000/µL, stop Eltrombopag; increase the frequency of platelet monitoring to twice weekly. Once the platelet count is \<150000/µL, reinitiate therapy at a daily dose reduced by 25 mg.

Sponsors & Collaborators

  • Fondazione Progetto Ematologia

    lead OTHER

Principal Investigators

  • Carlo Visco, MD · Department of Hematology, San Bortolo Hospital, Vicenza, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01610180 on ClinicalTrials.gov