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

NCT ID: NCT01980030

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-11-30

Brief 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.

Conditions

Persistent Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Romiplostim

Weekly Romiplostim for 12 weeks with intra-patient weekly dose escalation from 1µg/Kg to a maximum dose of 10 µg/Kg with a dose reduction schema in case of platelet overshoot

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Interventions

Romiplostim

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saint Louis hospital

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

P110204

Identifier Type: -

Identifier Source: org_study_id