Trials Sponsors Conditions Drugs Pricing

Conditions

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Primary Myelofibrosis Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

Number of Participants With a Platelet Response
The primary endpoint is complete (platelet) response (yes/no). A complete (platelet) response will be defined as a sustained (3 months) platelet count of \> 50 x 109/L for patients with CML and \> 100 x 109/L for patients with MF and at least a 20% increase in platelet count from baseline.
Up to 9 years

Secondary Outcomes (1)

Number of Participants With a Response to TKI Therapy After Eltrombopag
Up to 9 years

Study Arms (1)

Supportive care (eltrombopag olamine)

EXPERIMENTAL

Patients receive eltrombopag olamine PO QD in the absence of disease progression or unacceptable toxicity.

Drug: Eltrombopag Olamine

Interventions

Eltrombopag OlamineDrug

Given PO

Also known as: Promacta, SB-497115-GR

Supportive care (eltrombopag olamine)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

CML patients in chronic phase receiving treatment with any Food and Drug Administration (FDA) approved TKI; or CML patients in accelerated or blastic phase who are considered to be in this phase because of thrombocytopenia or because of clonal evolution and with no other criteria for accelerated/blastic phase or patients with myelofibrosis receiving treatment with FDA approved TKI and with peripheral blood and/or bone marrow blasts =\< 10%

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
M.D. Anderson Cancer Center
Otherlead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhasePrimary MyelofibrosisThrombocytopenia

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic Diseases

Results Point of Contact

Title: Gautam Borthakur MD./Professor
Organization: The University of Texas MD Anderson Cancer Center

Study Officials

Gautam Borthakur
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

21 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 5, 2011

Study Start

January 13, 2012

Actual (reported)

Eltrombopag Olamine in Treating Thrombocytopenia in Patients With Chronic Myeloid Leukemia or Myelofibrosis Receiving Tyrosine Kinase Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Supportive care (eltrombopag olamine)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Supportive care (eltrombopag olamine)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations