Asses the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood in Childrens

NCT ID: NCT05704894

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2025-11-30

Brief Summary

Anemia is a frequent complication among cancer patients, both as a result of the malignancy of the disease and the aggressiveness of the treatment. Regardless of the degree of anemia, cancer patients produce less erythropoietin (EPO) and, consequently, cannot compensate for the deficit in the production of red blood cells, a situation that can worsen in presence of inflammation or infection. In the pediatric oncology population, studies vary in relation to anemia treatment protocols, indications for starting treatment and even there is no robust evidence that treatment with erythropoiesis stimulators results in increased hemoglobin levels, even in mild and moderate anemia, with improvement in quality of life scores and fatigue. Therefore, the proposed study aims to test the efficacy and safety of erythropoietin therapy in the treatment of cancer-related anemia in children and adolescents aged 2 to 17 years. As a secondary objective, to evaluate the benefit of early initiation of EPO (Hb<12g/dL) in children undergoing chemotherapy in improving quality of life and reducing fatigue.

For the evaluation of secondary outcomes, the Student's t test can be applied and analyzes of variance or covariance (ANOVA or ANCOVA) (with treatment group as a factor, and baseline hemoglobin level as a covariate) will be used to compare the outcomes of efficacy defined by variation (change) time point post versus baseline between 2 groups. Adjusted means ("least square means") with 95% CI will be reported. When applicable, secondary outcomes defined by continuous variables evaluated over time (3 or more instants) will be analyzed using mixed model analysis of variance for repeated measures

Conditions

Anemia; Neoplasms; Chemotherapeutic-Induced Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Administration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between <12g/dL.

Every week (1 to 12), the study medication will be administered 3 times, according to the proposed treatment, for those allocated in the intervention group. All assessments, procedures and notes must be recorded in a source document and in a CRF.

Group Type: EXPERIMENTAL

Erythropoietin

Intervention Type: BIOLOGICAL

Administration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between \<12g/dL

Control Group

For the control group, the procedures will be performed according to the institution's standard treatment (Vitamin B12 and folic acid). The use of Iron, Vitamin B12 and folic acid will be allowed both in the intervention arm and in the control arm. Doses should be prescribed at the physician's discretion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Erythropoietin

Administration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between \<12g/dL

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Children between 2-17 years old
• Hemoglobin <12g/dL
• Solid tumors without bone metastasis
• Being on current chemotherapy treatment
• Adequate serum levels of iron, folic acid and Vitamin B12
• Signature of the Free and Informed Consent Form by the person responsible and Term of Assent by the patient

Exclusion Criteria

• Refusal to sign the Free and Informed Consent Form and/or Term of assent
• Estimated survival less than 12 weeks
• Previous adverse reactions associated with EPO
• Estar em uso de EPO e inibidores do fator de indução de hipóxia.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blau Farmaceutica S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Research

Role: STUDY_DIRECTOR

Blau Farmaceutica S.A.

Central Contacts

Blau Farmacêutica

Role: CONTACT

pesquisaclinica@blau.com

114615-9400

Research Operations

Role: CONTACT

Other Identifiers

ERITROBLA1222

Identifier Type: -

Identifier Source: org_study_id