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Treatment of Relapsed or Refractory Acute Myeloblastic Leukemia

NCT01435343 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2017-04-25

No results posted yet for this study

Summary

Second-line induction therapy with fludarabine, idarubicin, cytarabine,Granulocyte colony-stimulating factor (G-CSF) and plerixafor, in patients with relapsed or refractory Acute Myeloblastic Leukemia (AML) aged 65 or younger.

Conditions

  • Acute Myeloblastic Leukemia

Interventions

DRUG

fludarabine

30 mg/m2/day intravenously on days 1 to 4

DRUG

Idarubicin

10 mg/m2/day intravenously on days 1 to 3

DRUG

cytarabine

2 g/m2/day intravenously on days 1 to 4

DRUG

G-CSF

5 μg/kg/day subcutaneously from days 1 to 4

DRUG

plerixafor

intravenously from days 1 to 4

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-05-31
Completion
2016-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01435343 on ClinicalTrials.gov