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Safety And Efficacy Of Azacitidine, and Lenalidomide In Higher Risk Myelodysplastic Syndrome

NCT01053806 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-09-25

No results posted yet for this study

Summary

To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1 who are considered to be at high risk due to unfavorable additional factors.

* To evaluate the safety of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients.
* To evaluate the hematological improvement rate.
* To evaluate the cytogenetic response rate.
* To evaluate the Progression free survival (PFS).
* To assess Quality of life.

Conditions

Interventions

DRUG

5-Azacytidine and Lenalidomide

Induction:5-Azacytidine 75mg/m2/d S.C.or I.V. days 1-5 every 28 days a cycle for 6 cycles and Lenalidomide 10mg/d orally days 6-28 every cycle for 6 cycles Consolidation: 5-Azacytidine 75mg/m2/d S.C.or I.V. days 1-5 every 28 days for 6 cycles Maintenance: Lenalidomide 10mg/d orally days 1-21 every cycle of 28 days for 13 cycles.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-03-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

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 NCT01053806 on ClinicalTrials.gov