Repeat-dose Study of Lenalidomide (Revlimid ®) Plus Dexamethasone in Patients With Lymphoblastic Leukemia

NCT01116193 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-09-14

No results posted yet for this study

Summary

The study objectives are to evaluate the safety and efficacy of the oral administration of lenalidomide in combination with dexamethasone in the treatment of adult patients with refractory or relapsed non-Ph+ B-cell lineage acute lymphoblastic leukemia (ALL).

Conditions

  • Leukemia, Lymphoid
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

DRUG

Lenalidomide plus dexamethasone

Lenalidomide 25 mg p.o. once daily on days 1-21 plus Dexamethasone 40 mg p.o. once daily on days 1, 8, 15, and 22 of each 28-day cycle (4-weeks cycles) until CR achievement, progression of disease or intolerable toxicity

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY
  • Institut de Cancérologie de la Loire

    lead OTHER

Principal Investigators

  • Emmanuelle Tavernier, MD · Institut de Cancérologie de la Loire

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
2010-01-31
Primary Completion
2012-07-31
Completion
2013-08-31

Countries

  • France

Study Locations

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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 NCT01116193 on ClinicalTrials.gov