Epigallocatechin as an immunomodulatory and antineoplastic treatment in elderly patients with acute leukemia or mielodysplasia

Phase 2

Recruiting

• Conditions: Acute myeloid leukemia / High-risk myelodysplastic syndromes

• Registration Number: RBR-3nvjx2k
• Lead Sponsor: Centro de Hematologia e Hemoterapia de Campinas - Hemocentro da Unicamp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-13
• Last Update Posted: 29 May 2023
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age 60 years and over; Patients under age 60 will be allowed if they are found to be ineligible for high-dose conventional chemotherapy due to comorbidities; Patients with newly diagnosed or relapsed AML (myeloid blasts in peripheral blood or bone marrow above 20%); Patients with newly diagnosed of MDS with excess blasts (>10% blasts on myelogram or bone marrow biopsy); Performance status between 0 and 3 on the WHO-ECOG scale; Last chemotherapy treatment performed at least 60 days ago; Patients using hydroxyurea to control leukocytosis before starting study and can be maintained for up to 60 days; Patients who agree to participate in the study, after full understanding of the informed consent and voluntary signature of the informed consent.

Exclusion Criteria

Presence of psychiatric illness or other illness that affects the understanding of the informed consent; History of any previous neoplasm, with the exception of prolonged remission (more than 5 years) of non-melanoma skin cancers and cervical cancer in situ; Previous immunotherapy or biological therapy; Severe renal failure, characterized by creatinine clearance <30mL/minute; Total bilirubin above or equal to twice the upper limit of normality; AST and/or ALT above or equal to twice the upper limit of normality; Positive serologies for HCV, HBV or HIV; Uncontrolled intercurrent illness, such as active infection requiring antibiotic use, symptomatic congestive heart failure (NYHA class III or IV), or unstable angina; Women of childbearing age who are pregnant or nursing.

Study & Design

• Study Type: Intervention
• Study Design: Not specified