A study of eltrombopag in combination with azacitidine for subjects with low platelet counts due to intermediate 1, intermediate 2 or high risk Myelodysplastic Syndromes.

TRC112121 A phase III, randomized, double-blind, placebo-controlled, multi-center eltrombopague or placebo in combination with azacitidine in patients with Myelodysplastic Syndrome with IPSS intermediate-1 classification, intermediate-2 and high-risk.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-4m42nq

Enrollment

Unknown

Registered

2016-01-15

Start date

2014-05-23

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myelodysplastic syndromes,secondary thrombocytopenia

Interventions

In Brazil, 20 subjects will be randomized to one of the following treatment arms: eltrombopague combined with azacytidine or placebo combined with azacitidine. Therapeutic regimen is described below:E

dose adjustment min-max 100-300mg (50-150mg East Asian)

treatment continues as long as subject receives azacitidine. Placebo: Starting dose corresponding to the 200mg daily of the Eltrombopague (100mg East Asian)

treatment continues as long as subject receives azacitidine. Azacitidine: 75 mg/m2 per day for 7 days every 28 days, treatment continues as long as subject receives benefit or until disease progressio

Drug

N02.421.668.438

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Myelodysplastic Syndromes risk ranked at Intermediate 1, intermediate 2 or high according to IPSS;At least one platelet count lower than 75 Gi/L;Eastern Cooperative Oncology Group(ECOG) Status 0-2.; Adequate baseline organ function

Exclusion criteria

Exclusion criteria: Previous treatment with hypomethylating agent or induction chemotherapy for MDS;History of treatment with eltrombopag, romiplostim or other TPO-R agonists;Previous allogeneic stem-cell transplantation.

Design outcomes

Primary

Measure	Time frame
Platelet transfusion independence during Cycle 1-4 of azacitidine therapy platelet transfusion independence (The proportion of subjects who are platelet transfusion free during Cycles 1-4 of azacitidine therapy). This objective will be assessed by comparing the proportion of subjects receiving eltrombopag plus azacitidine who are platelet transfusion free during the first 4 cycles of azacitidine therapy, versus those treated with placebo plus azacitidine. platelet transfusions will be required if a subject’s platelet count is below 10 Gi/L or if a subject is bleeding or has platelets < 20 Gi/L based on local SOC.	—

Measure

Time frame

Platelet transfusion independence during Cycle 1-4 of azacitidine therapy platelet transfusion independence (The proportion of subjects who are platelet transfusion free during Cycles 1-4 of azacitidine therapy). This objective will be assessed by comparing the proportion of subjects receiving eltrombopag plus azacitidine who are platelet transfusion free during the first 4 cycles of azacitidine therapy, versus those treated with placebo plus azacitidine. platelet transfusions will be required if a subject’s platelet count is below 10 Gi/L or if a subject is bleeding or has platelets < 20 Gi/L based on local SOC.

—

Secondary

Measure	Time frame
Secondary endpoints compare the following in subjects treated with eltrombopag/azacitidine versus placebo/azacitidine: Overall survival;Disease response (per 2006 International Working Group criteria);Duration of Disease Response;Progression Free Survival;Time to Progression;Proportion of subjects that progress to Acute myeloid leukemia; Time to Acute myeloid leukemia progression	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Mexico, Norway, Peru, Poland, Republic of Korea, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United States

Contacts

Public ContactPesquisador Responsável - Contato Público

GlaxoSmithKline Brasil

sac.brasil@gsk.com+55 21 21416000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)