Velcaflagida in Relapsed or Refractary Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of this study is:

• To analyze the efficacy (in order to evaluate the response) of a sequential treatment scheme of Bortezomib in combination with Fludarabine,Cytarabine and Idarubicin continued with Bortezomib monotherapy for patients with relapsed or refractory AML ≥18 years old.

The safety aim of this study is:

• To evaluate the safety and tolerance of the sequential treatment scheme proposed with Bortezomib combined with Fludarabine, Cytarabine and Idarubicin and in monotherapy, measured on clinical toxicities and laboratory incidences.

The biological aim of this study is:

• To evaluate the Minimal Residual Disease (MRD)impact that will be monitored by multiparametric flow cytometry carried out at different moments during the treatment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• The patient must, according with investigator criteria,be able to comply with all the protocol requirements.

• The patient must sign voluntarily the informed consent before the performance of any study related procedure not part of usual medical care, with the knowledge that can leave the study the moment he/she wants, without prejudice to later medical care.

• Age ¡Ý 18 years old.

• Patient must be diagnosed with AML according World Health Organization (WHO)18 criteria (see Appendix 7).

• Patient with refractory AML after standard therapy, or relapsed AML after standard therapy or hematopoietic progenitors transplant (autologous or allogenic).

• Patient has a ECOG performance status <= 2 (see Appendix 5).

• Patient has the following laboratory values before Baseline visit:

1. Platelet count ≥ 30000/mm3 (transfusion allowed), hemoglobin ≥ 8 g/dl (transfusion allowed) and absolute neutrophil count ≥ 0.750/mm3. Lower values are accepted if they are caused by bone marrow infiltration.

2. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal.

3. Alanine transaminase (ALT): ≤ 2.5 x the upper limit of normal.

4. Total bilirubin: ≤1.5 x the upper limit of normal.

5. Serum creatinine value ≤ 2 mg/dl.

• Negative pregnant test for fertile females

Exclusion Criteria:

Prior Bortezomib therapy.

• Promyelocytic AML.

• Patient has > Grade 2 peripheral neuropathy within 14 days before enrollment.

• Fertile patient is not going to use a medical effective contraceptive method during the trial.

• Patient has received other investigational drugs within 30 days before enrollment.

• Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection.

• Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias,or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

• Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.

• Pregnant or breast-feeding women.