A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)

Myelodysplastic Syndromes Clinical Trial

Official title:

A Prospective Open-Label Study of the Effectiveness of Epoetin Beta for Treating Anemic Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome (MDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145026
• Other study ID #: ML29005
• Status: Completed
• Phase: Phase 4
• Start date: August 6, 2014
• Est. completion date: April 9, 2019

Study information

• Verified date: April 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase IV, prospective, multi-center, open-label study to assess the effectiveness and safety profile of epoetin beta (Recormon®) for treatment of symptomatic anemia in adult participants associated with low/intermediate-1-risk MDS. After screening, eligible participants will be treated with epoetin beta as recommended in the approved label and international guidelines for the use of epoetin in MDS participants and the dosage will be adjusted on the basis of erythroid response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 9, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants with low or intermediate-1 risk MDS

• No previous treatment with hematopoietic growth factors within 3 months prior to screening

• Symptomatic anemia (hemoglobin <10 g/dL) as determined by investigator

• Serum erythropoietin <500 milliunits/milliliter (mU/mL) within 14 days prior to the first dose of study treatment

• Require no red blood cell transfusion or dependent on <4 units within 8 weeks prior to screening

• Clinically stable for at least 1 month prior to entry into the study

• For female participants of childbearing potential and male participants with partners of childbearing potential, agreement (by participants and/or partner) to use highly effective form(s) of contraception

Exclusion Criteria:

• Contraindications and/or known hypersensitivity to the active substance and/or any of the excipients of epoetin beta treatment

• Poorly controlled hypertension as assessed by the investigator

• History of Acute Myeloid Leukemia (AML) or high risk for AML

• Administration of another investigational drug within 1 month before screening or planned during the study period

• Previously documented evidence of Pure Red Cell Aplasia (PRCA)

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Epoetin beta
Epoetin beta 30,000 or 60,000 IU per week SC injection

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine	Bangkok
Thailand	Rajavithi Hospital; Medicine	Bangkok
Thailand	Ramathibodi Hospital; Division of Hematology, Department of Medicine	Bangkok
Thailand	Siriraj Hospital; Division of Hematology, Department of Medicine	Bangkok
Thailand	Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine	Chiang Mai
Thailand	Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine	Khon Kaen
Thailand	Khonkean Regional Hospital; Medicine	Khon Kean
Thailand	Thammasart Chalermprakiert Hospital, Thammasart Uni; Hematology	Pathumthani
Thailand	Naresaun University hospital	Phitsanulok
Thailand	Sapprasitthiprasong Hospital	Ubon Ratchathani

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Achieving Erythroid Response at Week 12 as Assessed by International Working Group (IWG) 2006 Response Criteria	Erythroid response at Week 12 according to IWG 2006 criteria was defined as a hemoglobin (Hb) increase of >/= 1.5 grams/deciliter (g/dL), and a reduction of units of red blood cell (RBC) transfusions by at least 4 transfusions/8 weeks compared with the pre-treatment transfusion number in the previous 8 weeks. Only RBC transfusions given for an Hb of	Week 12
Secondary	Percentage of Participants With Platelet Response (in Participants With Pre-Treatment Platelets <100*10^9 Per Liter) at Week 12 as Assessed by IWG 2006 Response Criteria	Platelet response according to IWG 2006 criteria was defined as an absolute increase of >/= 30x10^9/L for participants starting with >20x10^9/L platelets.	Week 12
Secondary	Percentage of Participants With Neutrophil Response (in Participants With Pre-Treatment Neutrophil <1.0*10^9 Per Liter) at Week 12 as Assessed by IWG 2006 Response Criteria	Neutrophil response according to IWG 2006 criteria was defined as at least 100% increase and an absolute increase of >0.5x10^9/L.	Week 12
Secondary	Percentage of Participants With Adverse Events		From signing of informed consent up to 4 weeks after last dose (up to 18 weeks)