A Three-part Study of Eltrombopag in Thrombocytopenic Subjects with Myelodysplastic Syndromes or Acute Myeloid Leukemia (Part 1: open-label, Part 2: randomized, double-blind, Part 3: extension).ASPIRE: A Study of EltromboPag In Myelodysplastic SyndRomes and AcutE Myeloid Leukemia - PhII study in platelet transfusion dependent pts

GlaxoSmithKline Research and Development Ltd0 sites160 target enrollmentJanuary 4, 2012

ConditionsThrombocytopenic Subjects with Myelodysplastic Syndromes or Acute Myeloid Leukemia MedDRA version: 14.1Level: LLTClassification code 10028534Term: Myelodysplastic syndrome NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10060356Term: Acute myeloid leukaemia without mention of remissionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Immune System Diseases [C20]

DrugsRevolade

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Thrombocytopenic Subjects with Myelodysplastic Syndromes or Acute Myeloid Leukemia
Sponsor: GlaxoSmithKline Research and Development Ltd
Enrollment: 160
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 4, 2012

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research and Development Ltd

Eligibility Criteria

Inclusion Criteria

•Subjects eligible for enrolment in the study must meet all of the following criteria:
•1\. Adult subjects (18 years of age or older) with MDS or AML (bone marrow blasts \=50%) with thrombocytopenia due to bone marrow insufficiency from the disease or prior treatment. Subjects with transient thrombocytopenia due to active treatment with disease modifying agents or chemotherapy (except for hydroxyurea) are excluded.
•2\. Subjects must have Grade 4 thrombocytopenia (platelet counts \<25 Gi/L) due to bone marrow insufficiency (or platelet count \=25 Gi/L due to platelet transfusion).
•In addition, subjects must have had at least one of the following during the 4 week screening period: platelet transfusion, or symptomatic bleeding or platelet count \<10 Gi/L. Subjects whose thrombocytopenia below 10 Gi/L is due to causes other than bone marrow insufficiency (e.g., fever, infection, autoimmune disease) are not eligible.
•3\. Subjects must have platelet count, bleeding and platelet transfusion data available over a period of at least 4 weeks prior to randomization.
•4\. Prior systemic treatment for malignancy, with the exception of hydroxyurea (see Section 6\.1\.2\), must have been discontinued prior to entry into the study:
•at least 4 weeks before Day 1 for the following: chemotherapy, demethylating agents (azacitidine or decitabine), lenalidomide, thalidomide, clofarabine and IL\-11(oprelvekin);
•at least 8 weeks before Day 1 for antithymocyte/antilymphocyte globulin.
•5\. Subjects with a prior stem cell transplant (SCT) must have relapsed after the SCT.
•6\. Subjects must have stable disease (as defined by treatment guidelines and investigator discretion) and, in the opinion of the investigator, must be expected to complete a 12 week treatment period.

Exclusion Criteria

•Subjects meeting any of the following criteria must not be enrolled in the study:
•1\. Subjects with MDS and an IPSS of low or intermediate\-1 risk.
•2\. Subjects with a diagnosis of acute promyelocytic or megakaryocytic leukemia or AML secondary to a myeloproliferative neoplasm.
•3\. History of treatment with romiplostim or other TPO\-R agonists.
•4\. Subjects with a QTc \>480 msec (QTc \>510 msec for subjects with Bundle Branch Block) at baseline.
•5\. Subjects with a palpable spleen must have a splenic ultrasound to confirm spleen length is \=16 cm. Subjects with palpable spleen \>16 cm are not eligible.
•6\. Leukocytosis \=25,000/uL on Day 1 of treatment with study medication.
•7\. Subjects with known thrombophilic risk factors. Exception: Subjects for whom the potential benefits of participating in the study outweigh the potential risks of thromboembolic events, as determined by the investigator.
•8\. Female subjects who are nursing or pregnant (positive serum or urine ß\-human chorionic gonadotropin \[ß\-hCG] pregnancy test) at screening or pre\-dose on Day 1\.
•9\. Current alcohol or drug abuse.