Study in Hematological Malignancies

Phase 1

Conditions: Relapsed or refractory acute leukemiaElderly acute myeloid leukemia (patients >60)Myelodysplastic Syndrome (MDS)

Registration Number: RPCEC00000190

Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB).

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 10

Inclusion Criteria

1) Diagnosis of refractory AL after two cycles myeloablative standard chemotherapy, AL in early relapse (within 12 months) or second relapse or post-transplantation, the elderly AML not candidates for standard induction chemotherapy (3 +7), MDS with RAEB-1 and RAEB-2.
2) Patients no eligible for BMT at the time of inclusion.
3) Aged =18 years.
4) ECOG = 3.
5) Life expectancy > 5 weeks.
6) More than two weeks since prior therapy, including QT, or biological therapies.
7) Patients of childbearing potential must use an effective contraceptive method.
8) Express written request of the patient.

Exclusion Criteria

1) AML promyelocytic variant (M3).
2) Pregnancy, postpartum or breastfeeding.
3) Any type of active infection requiring specific treatment.
4) ALT or AST > 5 times the normal reference range.
5) Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, ischemic heart disease or other symptomatic cardiovascular disease, epilepsy, severe mental depression).
6) Medical history as severe allergic urticaria, atopic dermatitis, persistent bronchitis or bronchial asthma or any ingredient in the formulations studied.
7) Obvious mental disability or other limitation that prevents the patient sign the consent or hinder study assessments.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events (Occurrence of EA (Yes, No). EA Description (name of event). EA intensity (mild, moderate, severe). Measuring time: post administration at 15 minutes, 30 minutes and 60 minutes, and at any other time when an event is present.

Secondary Outcome Measures