Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I/II multicenter study which aims to assess the toxicity profile of Romiplostim in patients with transfusion-dependent thrombocytopenia after allogeneic HSCT.

A total of 24 patients with transfusion-dependent thrombocytopenia after allogeneic HSCT will be included.

The main endpoint is the incidence and severity of adverse events.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Criteria

Inclusion Criteria:

• Subjects must be ≥ 18 years, willing and able to sign informed consent

• Patients could have been transplanted for hematological disorder (malignant or non-malignant) excepted myelodysplastic syndromes patients and had received either a myeloablative or a reduced intensity conditioning. All sources of allogeneic stem cells are allowed.

• Prolonged (> 2 months) transfusion-dependent thrombocytopenia

• Screenings mean platelet count≤ 20 x giga/L or screenings mean platelet count ≤ 50 x giga/L with a history of bleeding.

• (ECOG) performance status of 0-2

• Adequate liver function

• Serum creatinine ≤ 176.8 μmol/L

• Bone marrow aspirate with cytogenetics within 6 days of the first dose of romiplostim

• Written informed consent

Exclusion Criteria:

• Relapse/progression of hematological malignancy (marrow examination required)

• Non-controlled acute and/or chronic graft versus host disease (GvHD)

• Active or uncontrolled infections

• Cardiac pathology - Thrombosis

• Pregnancy or breast feeding

• Received interleukin-11 (IL-11) within 4 weeks of screening or previously received any thrombopoietic growth factor

• Patients on anticoagulant therapy

• Receipt or planned receipt of Pegylated Granulocyte Colony Stimulating Factor (PEG-G-CSF), or Granulocyte macrophage-colony stimulating factor (GM-CSF) within 4 weeks of the first dose of investigational product

• Subject not using adequate contraceptive precautions, in the judgment of the investigator

• Sensitivity to any Escherichia coli-derived product

• Inability to comply with study procedures.

• Subject currently is enrolled in or has not yet completed 30 days since ending other investigational device or drug study

• No medical insurance in the French Health system