Know Cancer

forgot password

A Phase 1, Dose Escalation Study of Plerixafor in Combination With Induction and Consolidation Chemotherapy in Patients With Relapsed Acute Myeloid Leukemia

Phase 1
18 Years
65 Years
Open (Enrolling)
Acute Myeloid Leukemia

Thank you

Trial Information

A Phase 1, Dose Escalation Study of Plerixafor in Combination With Induction and Consolidation Chemotherapy in Patients With Relapsed Acute Myeloid Leukemia

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximal tolerated dose

Outcome Description:

4 steps of plerixafor doses from 240 to 480 microgram per kilogram per day concomitant with granulocyte-colony stimulating factor and chemotherapy Three to 6 evaluable patients will be enrolled at each dose level in a modified 3 + 3 design.

Outcome Time Frame:

40 days

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

Primal study



Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Acute Myeloid Leukemia
  • Plerixafor granulocyte-colony stimulating factor
  • Chemotherapy in relapse
  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid