Study in Plerixafor and Granulocyte-colony Stimulating Factor Patients With Relapse Acute Myeloid Leukemia

• Status: Terminated
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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 .

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

Details

• Lead Sponsor: French Innovative Leukemia Organisation
• Collaborators: Acute Leukemia French Association; Genzyme, a Sanofi Company
• Treatments: JM 3100; Lenograstim; Plerixafor; Sargramostim

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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