Trial record 12 of 650 for:    Open Studies | "Hematopoietic Stem Cells"

Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell (AGRAH003)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01980030
First received: November 4, 2013
Last updated: May 22, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Persistent Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Drug: Romiplostim
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence and severity of all adverse events


Secondary Outcome Measures:
  • Dose of Romiplostim [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    platelet count above 50 x 109/L on 8 consecutive weeks independent of platelet transfusions

  • Relapse rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Graft versus host disease (GVHD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Non relapse mortality rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • number of platelet transfusions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall number of bleeding events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • platelet hematological improvements [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence and duration of platelet hematological improvements above 20 x 109/L and above 50 x 109/L , respectively


Estimated Enrollment: 24
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01980030

Contacts
Contact: Gérard Socié, MD PhD 33 1 4249 98 24 gerard.socie@sls.aphp.fr

Locations
France
Saint Louis hospital Recruiting
Paris, Ile de France, France, 75010
Contact: Gérard Socié, MD PhD    +33 1 42 49 98 24    gerard.socie@sls.aphp.fr   
Contact: Régis PEFFAULT DE LA TOUR, MD PhD    +33 1 42 49 98 24    regis.peffaultdelatour@sls.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01980030     History of Changes
Other Study ID Numbers: P110204
Study First Received: November 4, 2013
Last Updated: May 22, 2014
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014