- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00874978
The Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion Dependent Subjects With Myelodysplastic Syndrome (MDS) Associated With Del (5q) Abnormality
February 26, 2019 updated by: King's College Hospital NHS Trust
The Efficacy and Safety of Lenalidomide (Revlimid®) Monotherapy in Red Blood Cell Transfusion Dependent Subjects With Myelodysplastic Syndrome Associated With Del (5q) Cytogenetic Abnormality
The purpose of this study is to evaluate the efficacy of lenalidomide treatments to achieve haematopoietic improvement in subjects with low- or intermediate-1 risk International Prognostic Scoring System1 (IPSS) myelodysplastic syndrome (MDS) associated with a del (5q31-33) cytogenetic abnormality.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SE5 9RS
- King's College Hospital NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Understand and voluntarily sign an informed consent form.
- Age over or equal to 18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of low- or intermediate-1-risk (IPSS) MDS associated with a del(5q) cytogenetic abnormality. The cytogenetic abnormality of chromosome 5 must involve a deletion between bands q31 and q33. The del(5q) cytogenetic abnormality may be an isolated finding or may be associated with other cytogenetic abnormalities.
- RBC transfusion-dependent anaemia defined as having no transfusion free interval of < 56 consecutive days within the past 112 days.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Women of childbearing potential (WCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
Laboratory test results within these ranges:
- Absolute neutrophil count over or equal to 0.5 x 109/L
- Platelet count over or equal to 25 x 109/L
- Serum creatinine under or equal to 2.0 mg/dl
- Total bilirubin under or equal to 1.5 mg/dl
- AST (SGOT) and ALT (SGPT) under or equal to 3 x ULN.
- Disease free of prior malignancies for over or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast.
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- Prior > grade 3 (National Cancer Institute [NCI] Common Toxicity Criteria [CTC]) allergic reaction to thalidomide.
- Prior > grade 3 (NCI CTC) rash or any desquamation (blistering) while taking thalidomide.
- Clinically significant anaemia due to factors such as iron, B12 or folate deficiencies,autoimmune or hereditary haemolysis or gastrointestinal bleeding (if a marrow aspirate is not evaluable for storage iron, transferrin saturation must be > 20 % and serum ferritin not less than 50 ng/ml).
- Use of haematopoietic growth factors within 7 days of the first day of study drug treatment. Use of G-CSF is permitted.
- Concurrent use of erythropoietin
- Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to >10 mg/day of prednisolone) within 28 days of the first day of study lenalidomide treatment.
- Use of experimental or standard drugs (i.e. chemotherapeutic, immunosuppressive, and cytoprotective agents) for the treatment of MDS within 28 days of the first day of study lenalidomide treatment.
- Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for >3 years.
- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments. Patients must not have received any form of chemotherapy for at least 4 weeks prior to study entry and must have fully recovered from haematological toxicity associated with this therapy.
- Known positive for HIV or infectious hepatitis, type A, B or C.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: lenalidomide
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Oral lenalidomide 10mg (two 5mg capsules) daily on days 1-21 every 28 days for up to 6 cycles.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Red blood cell (RBC) transfusion independence.
Time Frame: monthly
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monthly
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cytogenetic response
Time Frame: 3, 6 and 12 months
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3, 6 and 12 months
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Over or equal to 50% decrease in RBC transfusion requirements
Time Frame: monthly
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monthly
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Change of haemoglobin concentration from baseline
Time Frame: every 2 and 4 weeks
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every 2 and 4 weeks
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Safety (type, frequency, severity, and relationship of adverse events to lenalidomide)
Time Frame: monthly
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monthly
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Platelet response
Time Frame: every 2 and 4 weeks
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every 2 and 4 weeks
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Neutrophil response
Time Frame: every 2 and 4 weeks
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every 2 and 4 weeks
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Bone marrow response
Time Frame: 3, 6 and 12 months
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3, 6 and 12 months
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Duration of response
Time Frame: monthly
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monthly
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Gene expression profiling of patients with the 5q- syndrome and effects of lenalidomide on gene expression profiles
Time Frame: 3, 6 and 12 months
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3, 6 and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (ACTUAL)
May 1, 2016
Study Completion (ACTUAL)
May 1, 2016
Study Registration Dates
First Submitted
March 16, 2009
First Submitted That Met QC Criteria
April 2, 2009
First Posted (ESTIMATE)
April 3, 2009
Study Record Updates
Last Update Posted (ACTUAL)
February 27, 2019
Last Update Submitted That Met QC Criteria
February 26, 2019
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Preleukemia
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- 04CC06
- REC - 04/Q0703/148
- EudraCT - 2004-005101-29
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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