Study in Plerixafor and Granulocyte-colony Stimulating Factor Patients With Relapse Acute Myeloid Leukemia
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Plerixafor granulocyte-colony stimulating factor, Chemotherapy in relapse, Acute Myeloid Leukemia
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Plerixafor granulocyte-colony stimulating factor
Type: Drug
Overall Status
Recruiting
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 Cytarabine during induction therapy Then determine the tolerability of plerixafor administered in combination with G-CSF and cytarabine during consolidation therapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Xavier THOMAS
Lyon, France
Status: Recruiting
Contact: Karine CELLI LEBRAS, CRA - +33 157 2767 17
Start Date
January 2012
Completion Date
March 2015
Sponsors
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Source
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page