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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


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)
Primary Purpose: Treatment
Official Title: Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell
Study Start Date : November 2013
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Romiplostim

Arm Intervention/treatment
Experimental: 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
Drug: Romiplostim



Primary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]
    Incidence and severity of all adverse events


Secondary Outcome Measures :
  1. 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

  2. Durable platelet response after transplant: [ Time Frame: 12 months ]
    platelet count above 50 x 109/L on 8 consecutive weeks independent of platelet transfusions

  3. Relapse rate [ Time Frame: 12 months ]
  4. Graft versus host disease (GVHD) [ Time Frame: 12 months ]
  5. Non relapse mortality rate [ Time Frame: 12 months ]
  6. number of platelet transfusions [ Time Frame: 12 months ]
  7. Overall number of bleeding events [ Time Frame: 12 months ]
  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
France
Saint Louis hospital
Paris, Ile de France, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01980030     History of Changes
Other Study ID Numbers: P110204
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases