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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT01455025
• Date of registration: 24/06/2011
• Prospective Registration: Yes
• Primary sponsor: French Innovative Leukemia Organisation
• Public title: Study in Plerixafor and Granulocyte-colony Stimulating Factor Patients With Relapse Acute Myeloid Leukemia PRIMAL
• Scientific title: A Phase 1, Dose Escalation Study of Plerixafor in Combination With Induction and Consolidation Chemotherapy in Patients With Relapsed Acute Myeloid Leukemia
• Date of first enrolment: January 2012
• Target sample size: 11
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01455025
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Didier BOUSCARY, MD PD
• Affiliation: French Innovative Leukemia Organisation

• Name: Xavier THOMAS, MD PD
• Affiliation: ALFA

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Myeloid Leukemia

Intervention(s)

Drug: Plerixafor granulocyte-colony stimulating factor

Primary Outcome(s)

maximal tolerated dose [Time Frame: 40 days]

Secondary Outcome(s)

Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine [Time Frame: 2 months]

safety and tolerability of plerixafor in combination with granulocyte-colony stimulating factor and chemotherapy [Time Frame: 9 months]

Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine [Time Frame: 3 months]

Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine [Time Frame: 9 months]

Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine [Time Frame: 5 weeks]

Efficacy of plerixafor on leukemic blasts [Time Frame: 10 Days]

Secondary ID(s)

Primal study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Acute Leukemia French Association

Genzyme, a Sanofi Company