Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell (AGRAH003)
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|ClinicalTrials.gov Identifier: NCT01980030|
Recruitment Status : Active, not recruiting
First Posted : November 8, 2013
Last Update Posted : June 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Persistent Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)||Drug: Romiplostim||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell|
|Study Start Date :||November 2013|
|Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||November 2017|
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
- Adverse events [ Time Frame: 12 months ]Incidence and severity of all adverse events
- Dose of Romiplostim [ Time Frame: 12 months ]Dose of Romiplostim required to reach a platelet count above 50 x 109/L in absence of platelet transfusion
- Durable platelet response after transplant: [ Time Frame: 12 months ]platelet count above 50 x 109/L on 8 consecutive weeks independent of platelet transfusions
- Relapse rate [ Time Frame: 12 months ]
- Graft versus host disease (GVHD) [ Time Frame: 12 months ]
- Non relapse mortality rate [ Time Frame: 12 months ]
- number of platelet transfusions [ Time Frame: 12 months ]
- Overall number of bleeding events [ Time Frame: 12 months ]
- platelet hematological improvements [ Time Frame: 12 months ]Incidence and duration of platelet hematological improvements above 20 x 109/L and above 50 x 109/L , respectively
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980030
|Saint Louis hospital|
|Paris, Ile de France, France, 75010|