|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
21 November 2016 |
|
Main ID: |
NCT01718379 |
|
Date of registration:
|
23/10/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.
|
|
Scientific title:
|
A Phase II Study Evaluating the Efficacy/Safety of Lenalidomide With or Without Epoetin Beta in Transfusion-dependent ESA-resistant Patients With IPSS Low- and Intermediate-1 Risk Myelodysplastic Syndromes Without Chromosome 5 Abnormality. |
|
Date of first enrolment:
|
July 2010 |
|
Target sample size:
|
132 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01718379 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
France
|
Monaco
| | | | | | |
|
Contacts
|
|
Name:
|
Andréa TOMA, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Groupe Francophone des Myelodysplasies |
|
|
Name:
|
François Dreyfus, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Groupe Francophone des Myelodysplasies |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
MDS defined as
- Low or int-1 IPSS score
- Documented absence of chromosome 5 abnormality (del(5q) or -5 karyotype)
- De novo MDS, excluding therapy-related MDS AND
- Transfusion dependance (requirement of at least 4 units of RBC transfusions every 8
weeks )
- Resistance or loss of response to a previous treatment with Epoetin alpha/beta (at
least 60,000 Units/w) or Darbepoetin (at least 250 µg/w), for at least 12 weeks
- Ineligibility for allogeneic stem cell transplantation or intensive chemotherapy
during the next 12 months
- ECOG performance status = 2
- Age = 18 years
- Life expectancy = 3 months
- Adequate liver function (transaminases serum levels = 3N)
- Adequate renal function (calculate creatinine clearance > 50 ml/min)
- Female subjects of chilbearing potential* must :
Agree to use effective contraception without interruption throughout the study and for at
least 4 weeks after the end of treatment
• Men must: Agree to not conceive during the treatment and to use effective contraception
during the treatment period (including periods of dose reduction or temporary suspension)
and during one week after end of treatment if their partner is of childbearing potential.
Exclusion Criteria:
- Active serious infection not controlled by oral or intravenous antibiotics
- Platelets less than 50 G/L
- Prior history of deep vein thrombosis or pulmonary embolism
- Previous treatment by Thalidomide
- Treatment with any investigational antileukemic agent or chemotherapy at least 6
weeks prior to study entry and lack of full recovery from side effects due to prior
therapy independent of when that therapy were given
- Rapidely progressive disease with copromised organ function judged to be
life-threatening by the Investigator
- Pregnant or lactating female
- Known human immunodeficiency virus (HIV) infection
- Known active hepatitis B and/or C virus infection
- Hypersensitivity or intolerance to Lenalidomide or any of the excipients
- Hypersensitivity to Epoetin beta or any of the excipients
- Uncontrolled arterial hypertension
- Any history of malignancy (other than myelodysplastic syndrome) unless the patient
has remained disease free for more than 5 years
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Myelodysplastic Syndromes
|
|
Intervention(s)
|
|
Drug: Epoetin beta
|
|
Drug: Lenalidomide
|
|
Primary Outcome(s)
|
|
Comparing the efficacy of Lenalidomide alone to Lenalidomide with Epoetin beta in transfusion-dependent ESA-resistant
[Time Frame: After 4 months of treatment]
|
|
Secondary Outcome(s)
|
|
will be to assess the safety of Lenalidomide and of its combination with Epoetin beta
[Time Frame: After 2 months of treatment]
|
|
Secondary ID(s)
|
|
GFM-Len-Epo-08
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|