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Treatment of Relapsed or Refractory Acute Myeloblastic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by PETHEMA Foundation
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT01435343
First received: September 14, 2011
Last updated: October 27, 2014
Last verified: November 2013
  Purpose

Second-line induction therapy with fludarabine, idarubicin, cytarabine,Granulocyte colony-stimulating factor (G-CSF) and plerixafor, in patients with relapsed or refractory Acute Myeloblastic Leukemia (AML) aged 65 or younger.


Condition Intervention Phase
Acute Myeloblastic Leukemia
Drug: fludarabine
Drug: Idarubicin
Drug: cytarabine
Drug: G-CSF
Drug: plerixafor
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Prospective, Open-label, Single-arm, Phase I-II Clinical Trial to Analyze Induction Therapy With a Combination of Fludarabine, Idarubicin, Cytarabine, G-CSF and Plerixafor for the Treatment of Young Patients With Relapsed or Refractory AML

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Efficacy in terms of number of complete responses [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety in terms of percentages of adverse events presented [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fludarabine
    30 mg/m2/day intravenously on days 1 to 4
    Drug: Idarubicin
    10 mg/m2/day intravenously on days 1 to 3
    Drug: cytarabine
    2 g/m2/day intravenously on days 1 to 4
    Drug: G-CSF
    5 μg/kg/day subcutaneously from days 1 to 4
    Drug: plerixafor
    intravenously from days 1 to 4
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of AML according to the WHO criteria
  • Relapsed or refractory AML as defined below First relapse after standard treatment with duration of the first remission less than year
  • Refractoriness to an induction cycle that includes cytarabine and anthracyclines
  • Nonpromyelocytic leukemia (absence of t(15;17) or PML-RARα rearrangement and its variants)
  • Peripheral blood blast cell count less than 50 x 109/L. Hydroxyurea and leukopheresis can be used to lower the blast count prior to beginning treatment
  • Age ≤ 65 years and ≥ 18 years
  • ECOG performance status of 0-2
  • Provide signed written informed consent
  • Be able to comply with study procedures and follow-up examinations
  • Be nonfertile or agree to use birth control during the study through the end of last treatment visit
  • Adequate renal and hepatic function as indicated by all of the following:

Total bilirubin <1.5 x Institutional Upper Limit of Normal (ULN); and AST and ALT <2.5 xULN; and Serum creatinine <1.0 mg/dL; if serum creatinine <1.0 mg/dL, then, the estimated glomerular filtration rate (GFR) must be <60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation - Minimal impairment of cardiac function as measured by at least 1 of the following: Left ventricular ejection fraction (LVEF) >40% on multigated acquisition (MUGA) scan or radionuclide angiographic scan; or Left ventricular fractional shortening >22% on echocardiography exam;

Exclusion Criteria:

  • Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t(15;17)(q22;q12), (PML/RARalfa and variants)
  • AML secondary to previous treatment for myelodysplastic syndrome (MDS)
  • Peripheral blood blast cell count ≥ 50 x 109/L. Hydroxyurea and leukopheresis can be used to lower the blast count prior to beginning treatment
  • Prior investigational treatment within 30 days prior to the first dose of study drug. If any investigational treatment has been received prior to this time point, drug related toxicities must have recovered to Grade 1 or less prior to first dose of study drug
  • Prior hematopoietic stem cell transplant (HSCT) (previous autologous hematopoietic stem cell transplant is allowed)
  • Investigational agent received within 5 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 1 or less prior to first dose of study drug
  • Impaired renal and liver function as indicated by the following:

Total bilirubin > 1.5 x upper limit of normal (ULN) provided that this is not attributable to AML itself; or AST and ALT > 2.5 xULN provided that this is not attributable to AML itself; or Serum creatinine > 1.0 mg/dL provided that the estimated glomerular filtration rate (GFR) is ≤ 60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation

- Impaired cardiac function as measured by at least 1 of the following: Left ventricular ejection fraction (LVEF) < 40% on multigated acquisition (MUGA) scan or radionuclide angiographic scan; or Left ventricular fractional shortening < 22% on echocardiography exam;

  • Poor overall condition ECOG 3-4
  • Refusal to sign the informed consent
  • Unable to comply with study procedures and follow-up examinations
  • Psychiatric disorders that could interfere with consent, study participation or follow-up
  • Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
  • Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions:

Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed

  • Clinical evidence suggestive of central nervous system (CNS) involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal fluid (CSF)
  • Prior positive test for the human immunodeficiency virus (HIV)
  • History of hypersensitivity to any of the study drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435343

Contacts
Contact: Federico Moscardó, Dr fedemoscardo@yahoo.es

Locations
Spain
Hospital Universitari Germans Trials i Pujol Recruiting
Badalona, Spain
Contact: Dr. Jose Maria Ribera, Dr         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Javier Bueno, Dr         
Hospital de la Santa Creu i Sant Pau. Recruiting
Barcelona, Spain
Contact: Jordi Sierra, Dr         
Hospital Duran i Reynals - ICO L'Hospitalet Recruiting
Barcelona, Spain
Contact: Dr. Rafael Duarte Palomino, Dr         
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain
Contact: Jordi Esteve, Dr         
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain
Contact: Josefina Serrano, Dr         
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Contact: Eloy Del Potro, Dr         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Contact: Pilar Martínez Sánchez, Dr         
Hospital Clínico Universitario de Salamanca Recruiting
Salamanca, Spain
Contact: Belén Vidriales, Dr         
Hospital Universitari La Fe Recruiting
Valencia, Spain
Contact: Federico Moscardó, Dr         
Sponsors and Collaborators
PETHEMA Foundation
  More Information

No publications provided

Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT01435343     History of Changes
Other Study ID Numbers: PLERIFLAG
Study First Received: September 14, 2011
Last Updated: October 27, 2014
Health Authority: Spain: Ministry of Health and Consumption

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Cytarabine
Fludarabine
Fludarabine phosphate
Idarubicin
JM 3100
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014