Status:
TERMINATED
Study in Plerixafor and Granulocyte-colony Stimulating Factor Patients With Relapse Acute Myeloid Leukemia
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborating Sponsors:
Acute Leukemia French Association
Genzyme, a Sanofi Company
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a phase 1, dose escalation study of Plerixafor in combination with granulocyte-colony stimulating factor , Daunorubicin and Cytarabine in adults patients with relapsed acute myeloid leukemia .
Detailed Description
The Primary objective is to determine the maximal tolerated dose and Recommended Phase 2 Dose of plerixafor when used in combination with granulocyte-colony stimulating factor, Daunorubicin and Cytara...
Eligibility Criteria
Inclusion
- Patients with Acute Myeloid Leukemia in first relapse with first response duration \> 9 months.
- Age between 18 and 65 years.
- Treatment with hydroxyurea or purinethol is allowed if discontinued at least 24 hours before the start of study treatment.
- White blood count less than 30 x 109/L
- Left ventricular ejection fraction more than 50% on echocardiography or multigated acquisition scan or similar radionuclide angiographic scan.
- Total bilirubin less than 1.5 x upper limit of normal= ULN or AST and ALT less than 2.5 x ULN or gammaGT less than 2.5 x ULN.
- Serum creatinine less than 1.5 x ULN and/or creatinine clearance more than 50 ml/mn.
- ECOG performance status less than 2
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Absence of pregnancy or lactation
- Affiliated to French social security system or similar
- Signed informed consent
Exclusion
- AML evolving from MPD and/or secondary AML
- Patients treated with more than 270 mg/m2 of daunorubicin during first line therapy.
- Have any of the following within the last 9 months :
- Unstable supraventricular arrhythmia or patient with a pace-maker
- Any ventricular arrhythmia
- Congestive heart failure
- Myocardial infarction, ischemia, stable coronary disease or angina pectoris
- Syncope with a known cardiovascular etiology
- Known hypersensitivity or contra-indication to drugs used in the protocol = G-CSF, daunorubicin, cytarabine or to excipients.
- Previous treatment with plerixafor.
- Previous hematopoietic stem cell transplantation = Allologous or autologous.
- White blood count more than 30 x 109/L despite treatment with hydroxyurea or purinethol.
- Treatment with chemotherapy or G-CSF within 3 months of screening.
- Uncontrolled active infection.
- Uncontrolled arrythmia
- Grade more than 3 renal dysfunction with serum creatinine more than 1.5 x ULN and/or creatinine clearance less than 50 ml/mn.
- Significant neurologic grade more than 2 or psychiatric disorder, dementia or seizures.
- Clinical symptoms suggesting active central nervous system leukemia.
- Pre-existing disorder predisposing the patient to serious or life-threatening infections = cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder or cytopenia
- Thrombocytopenia refractory to platelet transfusion
- Anticoagulant therapy
- Severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock or disseminated intravascular coagulation.
- Thrombocytopenia refractory to platelet transfusion.
- Prior total body irradiation more than 10 Gy.
- Known HIV, Hepatitis B or C positivity.
- Participation into a clinical study of an investigational agent within 14 days before study entry.
- Pregnancy or breastfeeding
- Adult patient protected by law
- Concurrent treatment with any other anti-cancer therapy except hydroxyurea
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01455025
Start Date
January 1 2012
End Date
August 1 2015
Last Update
March 16 2016
Active Locations (1)
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1
Xavier THOMAS
Lyon, France, 69437