ClinicalTrials.Veeva

Menu

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

F

French Innovative Leukemia Organisation

Status and phase

Terminated
Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Plerixafor granulocyte-colony stimulating factor

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01455025
Primal study

Details and patient eligibility

About

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 .

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

Plerixafor granulocyte-colony stimulating factor
Experimental group
Description:
4 steps of plerixafor doses from 240 to 480 microgram/kg per day concomitant with GCSF and chemotherapy 3 to 6 evaluable patients will be enrolled at each dose level in a modified 3 + 3 design.
Treatment:
Drug: Plerixafor granulocyte-colony stimulating factor

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems