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LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)

NCT01198054 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2014-04-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained response treatment (total resistance) or partial remission.

At the same time, the study evaluate the security of lenalidomide.

Conditions

Interventions

DRUG

Lenalidomide

Initial dose of oral lenalidomide is 10 mg/day for 28 days every 28 days, during 6 months. In case of response on day 169, patient will follow a treatment extension phase. The dose of lenalidomide should be the same as the last dose for initial phase, until 24 months or progression disease

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Sanz Miguel, Dr · PETHEMA Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01198054 on ClinicalTrials.gov