Persistent Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Clinical Trial
— AGRAH003Official title:
Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell
| Verified date | February 2019 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | November 2018 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Saint Louis hospital | Paris | Ile De France |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse events | Incidence and severity of all adverse events | 12 months | |
| Secondary | Dose of Romiplostim | Dose of Romiplostim required to reach a platelet count above 50 x 109/L in absence of platelet transfusion | 12 months | |
| Secondary | Durable platelet response after transplant: | platelet count above 50 x 109/L on 8 consecutive weeks independent of platelet transfusions | 12 months | |
| Secondary | Relapse rate | 12 months | ||
| Secondary | Graft versus host disease (GVHD) | 12 months | ||
| Secondary | Non relapse mortality rate | 12 months | ||
| Secondary | number of platelet transfusions | 12 months | ||
| Secondary | Overall number of bleeding events | 12 months | ||
| Secondary | platelet hematological improvements | Incidence and duration of platelet hematological improvements above 20 x 109/L and above 50 x 109/L , respectively | 12 months |