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

NCT01455025 | Terminated Phase 1 DMC

• 1 other identifier: Primal study
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Acute Myeloid Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• maximal tolerated dose

  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.

  40 days

Secondary Outcomes (8)

• safety and tolerability of plerixafor in combination with granulocyte-colony stimulating factor and chemotherapy

  9 months

• Efficacy of plerixafor on leukemic blasts

  10 Days

• Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine

  2 months

• Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine

  5 weeks

• Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine

  3 months

Study Arms (1)

Plerixafor granulocyte-colony stimulating factor

EXPERIMENTAL

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.

Drug: Plerixafor granulocyte-colony stimulating factor

Interventions

Plerixafor granulocyte-colony stimulating factor DRUG

Induction phase Plerixafor IV from D1 to D3 and from D8 to D10, granulocyte-colony stimulating factor IV 5 μg/kg/day from D1 to D10, Intravenous daunorubicin 60 mg/m2/day from D1 to D3 Cytarabine 500 mg/m2/day continuous infusion over 24h from D1 to D3 followed by cytarabine 2-hour bolus of 1000 mg/m2/12h from D8 to D10. Consolidation phase Plerixafor at D1, D3 and D5, granulocyte-colony stimulating factor IV 5 μg/kg/day from D1 to D5, Cytarabine continuous infusion of 3-h bolus of 3000 mg/m2/12h D1, D3 and D5

Also known as: Plerixafor G CSF

Plerixafor granulocyte-colony stimulating factor

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead
• Acute Leukemia French Association: collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Xavier THOMAS

Lyon, 69437, France

Location

Related Links

• FILO website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xavier THOMAS, MD PD

  ALFA

  PRINCIPAL INVESTIGATOR

• Didier BOUSCARY, MD PD

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: October 19, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2015-08

Locations

FR (1)