Status:
COMPLETED
Velcaflagida in Relapsed or Refractary Acute Myeloid Leukemia
Lead Sponsor:
PETHEMA Foundation
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 Idarubici...
Detailed Description
Initially a phase I will be performed to determine the appropriate dose of Cytarabine to be used in Flag-Ida regimen in combination with Velcade; for that reason, first 9 patients will be distributed ...
Eligibility Criteria
Inclusion
- 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:
- 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.
- Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal.
- Alanine transaminase (ALT): ≤ 2.5 x the upper limit of normal.
- Total bilirubin: ≤1.5 x the upper limit of normal.
- Serum creatinine value ≤ 2 mg/dl.
- Negative pregnant test for fertile females
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00651781
Start Date
April 1 2008
End Date
February 1 2013
Last Update
February 28 2013
Active Locations (13)
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1
Hospital Universitario de Salamanca
Salamanca, Salamanca, Spain
2
Hospital Juan Canalejo
A Coruña, Spain
3
Hospital Germans Trias I Pujol
Badalona, Spain
4
Hospital Clinic y Provincial de Barcelona
Barcelona, Spain