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CompletedNCT01980030AGRAH003Updated Feb 15, 2019

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

A Phase 1/2 interventional study of Romiplostim in Persistent Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Persistent Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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03

In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's planned enrollment of 24 is below the median of 55 across 472 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • 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

Interventions

  • DrugRomiplostim
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What researchers measure

Primary outcomes

  1. Adverse events

    Incidence and severity of all adverse events

    Time frame: 12 months

Secondary outcomes

  1. Dose of Romiplostim

    Dose of Romiplostim required to reach a platelet count above 50 x 109/L in absence of platelet transfusion

    Time frame: 12 months

  2. Durable platelet response after transplant:

    platelet count above 50 x 109/L on 8 consecutive weeks independent of platelet transfusions

    Time frame: 12 months

  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

    Incidence and duration of platelet hematological improvements above 20 x 109/L and above 50 x 109/L , respectively

    Time frame: 12 months

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Study locations

1 site
  • Saint Louis hospital
    Paris, Ile De France 75010, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01980030
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Nov 8, 2013
Start date
Nov 2013
Primary completion
Dec 2015
Completion
Nov 2018
Last update
Feb 15, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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