Myelodysplastic SyndromesPhase 2NCT00874978
The Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion Dependent Subjects With Myelodysplastic Syndrome (MDS) Associated With Del (5q) Abnormality
A Phase 2 study testing lenalidomide in people with Myelodysplastic Syndromes, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 9RS
About this study
Official title: 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.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- lenalidomide
- Keywords
- Lenalidomide, myelodysplastic syndromes
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Also called Revlimid, CC-5013
Oral lenalidomide 10mg (two 5mg capsules) daily on days 1-21 every 28 days for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| lenalidomide | Experimental | Not described Receives: Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell (RBC) transfusion independence.
Measured: monthly
Secondary outcomes (9)
Cytogenetic response
Measured: 3, 6 and 12 months
Over or equal to 50% decrease in RBC transfusion requirements
Measured: monthly
Change of haemoglobin concentration from baseline
Measured: every 2 and 4 weeks
Safety (type, frequency, severity, and relationship of adverse events to lenalidomide)
Measured: monthly
Platelet response
Measured: every 2 and 4 weeks
Neutrophil response
Measured: every 2 and 4 weeks
Bone marrow response
Measured: 3, 6 and 12 months
Duration of response
Measured: monthly
Gene expression profiling of patients with the 5q- syndrome and effects of lenalidomide on gene expression profiles
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startJan 2005
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Ghulam J Mufti, MB, DM, FRCP, FRCPath, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874978
- Sponsor's protocol ID
- 04CC06
- Other IDs
- REC - 04/Q0703/148, EudraCT - 2004-005101-29
- Status last verified
- Sep 2015
- First submitted
- 16 Mar 2009
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Lenalidomide (Revlimid®) Monotherapy in Red Blood Cell Transfusion Dependent Subjects With Myelodysplastic Syndrome Associated With Del (5q) Cytogenetic Abnormality
- ClinicalTrials.gov ID
- NCT00874978
- Acronym / sponsor ID
- 04CC06
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Lenalidomide, myelodysplastic syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lenalidomide | Experimental | Drug: lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenalidomideAlso: Revlimid, CC-5013Oral lenalidomide 10mg (two 5mg capsules) daily on days 1-21 every 28 days for up to 6 cycles. | Drug | lenalidomide |
Primary outcome
Red blood cell (RBC) transfusion independence.
Time frame: monthly
9 secondary outcomes
Cytogenetic response
Time frame: 3, 6 and 12 months
Over or equal to 50% decrease in RBC transfusion requirements
Time frame: monthly
Change of haemoglobin concentration from baseline
Time frame: every 2 and 4 weeks
Safety (type, frequency, severity, and relationship of adverse events to lenalidomide)
Time frame: monthly
Platelet response
Time frame: every 2 and 4 weeks
Neutrophil response
Time frame: every 2 and 4 weeks
Bone marrow response
Time frame: 3, 6 and 12 months
Duration of response
Time frame: monthly
Gene expression profiling of patients with the 5q- syndrome and effects of lenalidomide on gene expression profiles
Time frame: 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghulam J Mufti, MB, DM, FRCP, FRCPath principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lenalidomide in people with Myelodysplastic Syndromes, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red blood cell (RBC) transfusion independence. (time frame: monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.