Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
PETHEMA Foundation |
---|---|
Information provided by: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00651781 |
The primary aim of this study is:
The safety aim of this study is:
The biological aim of this study is:
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia |
Drug: Bortezomib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II National, Open-Label, Multicenter Study of Bortezomib (Velcade) in Combination With FLAG-IDA (VFLAG- IDA) in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML). |
Estimated Enrollment: | 40 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | May 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Phase I:3 dose levels Cytarabine (200 mg/m2- 500 mg/m2-1000 mg/m2) with scheme Flag-Ida in combination with Velcade until determinate the appropriate dose. Phase II: Fludarabine, Cytarabine and Idarubicin in combination with 2 times per week of Velcade administration. Each 28-day treatment, patients will be evaluated, and in absence of disease progression or unacceptable toxicity, patients will start second cycle with Bortezomib in monotherapy two times per week followed by a 10 days rest period. That is, patients who response with acceptable toxicity will receive the combined sequential scheme twice (as induction and consolidation). |
Drug: Bortezomib
2 times per week of Velcade administration.
|
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 to 3 different cohorts with 3 patients in each cohort, which will be treated at each Cytarabine dose level (200 mg/m2-500 mg/m2-1000 mg/m2)in combination with the other drugs from Flag scheme and the fixed dose of Velcade at 1,3 mg/m2. Once the appropriate Cytarabine dose is determined,the recruitment will be completed with 40 patients and evaluations and visits program will be realized in three periods: Pre-treatment, Treatment and Follow-up. The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility.
Eligible patients included in the study will receive the first cycle, which consist of Fludarabine, Cytarabine and Idarubicin in combination with 2 times per week of Velcade administration. Each 28-day treatment, patients will be evaluated, and in absence of disease progression or unacceptable toxicity, patients will start second cycle with Bortezomib in monotherapy two times per week followed by a 10 days rest period. That is, patients who response with acceptable toxicity will receive the combined sequential scheme twice (as induction and consolidation).
Patients will be evaluated the day 1 of each cycle,during the treatment period, in order to know the response before carrying on the treatment. Once the Treatment period is completed, patients will be evaluated during the Follow-up period, one monthly visit in year 1, and every 3 months for 3 next years. On each center criteria, autologous/allogeneic transplant can be planned depending on age and HLA identical sibling donor make it possible: it will be done following the sequential scheme (Velcade-Flag-Ida and Velcade in monotherapy); if the patient is not candidate for a transplant or has no donor, he/she will receive 2 sequential scheme. Safety will be evaluated through all adverse events monitoring, physical exploration, vital signs, hematimetric and biochemical analysis. The treatment response will be evaluated using Cheson's standardized criteria, and MRD impact will be necessary evaluated the day 1 of each new cycle before to carry on the treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has the following laboratory values before Baseline visit:
Exclusion Criteria:
Prior Bortezomib therapy.
Contact: San Miguel Jesús, DR | 923 2913 84 |
Spain | |
Hospital 12 de Octubre | Recruiting |
Madrid, Spain | |
Contact: Lahuerta Juan José, Dr | |
Hospital Clínico San Carlos. | Recruiting |
Madrid, Spain | |
Contact: Diaz Mediavilla Joaquin, Dr | |
Hospital Ramón y Cajal. Madrid | Recruiting |
Madrid, Spain | |
Contact: Lopez J, Dr | |
Hospital La Fe de Valencia | Recruiting |
Valencia, Spain | |
Contact: Sanz Miguel Angel, Dr | |
Hospital Santa Creu y Sant Pau.Barcelona | Recruiting |
Barcelona, Spain | |
Contact: Brunet Salut, Dr | |
Hospital Clinic y Provincial de Barcelona | Recruiting |
Barcelona, Spain | |
Contact: Esteve Jordi, Dr | |
Hospital Universitario de Salamanca | Recruiting |
Salamanca, Spain | |
Contact: San Miguel Jesús, Dr | |
Hospital Morales Messeguer | Recruiting |
Murcia, Spain | |
Contact: Amigó ML, Dr | |
Hospital Lozano Blesa | Recruiting |
Zaragoza, Spain | |
Contact: Palomera Luis, Dr | |
Hospital Central de Asturias | Recruiting |
Oviedo, Spain | |
Contact: Rayón MC, Dr | |
Hospital Germans Trias I Pujol | Recruiting |
Badalona, Spain | |
Contact: Oriol A., Dr | |
Hospital Vall d´hebron | Recruiting |
Barcelona, Spain | |
Contact: Bueno J., Dr | |
Hospital Juan Canalejo | Recruiting |
La Coruña, Spain | |
Contact: Deben Guillermo, Dr |
Study Chair: | San Miguel Jesús, Dr | PETHEMA Foundation |
Responsible Party: | Pethema ( Pethema ) |
Study ID Numbers: | Nº EudraCT: 2005-004370-24, IIS-VEL-EU-070/26866138CAN2015 |
Study First Received: | March 31, 2008 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00651781 History of Changes |
Health Authority: | Spain: Ministry of Health |
Acute Myeloid Leukemia Relapsed Refractory |
Leukemia Acute Myelocytic Leukemia Bortezomib |
Leukemia, Myeloid Leukemia, Myeloid, Acute Protease Inhibitors |
Leukemia Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Bortezomib Enzyme Inhibitors Leukemia, Myeloid Leukemia, Myeloid, Acute Pharmacologic Actions Protease Inhibitors |