MDSPhase 2NCT00761449
Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5
A Phase 2 study testing lenalidomide in people with MDS and AML, run by Nordic MDS Group at 18 sites in 3 countries.
Trial summary
The aim of this study is to investigate the efficacy of lenalidomide in high risk MDS or AML with chromosome 5 aberrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 28 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Oct 2007to Dec 2009
- 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
- Must be >18 years of age at the time of signing the informed consent form
- MDS at IPSS Int-2 or High with a karyotype including del(5q) or monosomy 5 confirmed with FISH (using the LSI EGR1/D5S23,D5S721 FISH probe)
- Acute myeloid leukemia with a karyotype including del(5q) or monosomy 5 confirmed with FISH (using the LSI EGR1/D5S23,D5S721 FISH probe)
- Patients could be included if:
- At diagnosis and not considered eligible for induction chemotherapy
- Refractory to induction therapy
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- Relapse after induction chemotherapy leading to CR and considered not eligible for reinduction
- Relapse after allogeneic stem cell transplantation and not considered suitable for reinduction chemotherapy or other conventional relapse therapy.
- Subject has signed the informed consent document.
- Women of childbearing potential, WCBP, must agree to practice complete abstinence from heterosexual intercourse or to use two methods of contraception beginning 4 weeks prior to the start of the study medication, while on study medication and 4 weeks after the last dose of study medication. WCBP must have two negative serum or urine pregnancy tests prior to starting study drug. WCBP must agree to have pregnancy tests weekly for the first 4 weeks and then every 4 weeks while on study medication and 4 weeks after the last dose of study medication.
- Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study medication and 4 weeks after the last dose of study medication.
Who cannot join
- Pregnant or lactating females.
- Prior therapy with lenalidomide
- Patients who are eligible for curative treatment
- Expected survival less than two months.
- Acute promyelocytic leukemia (APL)
- Absolute peripheral blast count >30,000/mm3
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- Central nervous system leukemia
- Serum biochemical values as follows
- Serum creatinine >2.0 mg/dL (177 micromol/L)
- Serum aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) >3.0 x upper limit of normal (ULN)
- Serum total bilirubin >1.5 mg/dL (26 micromol/L)
- Prior allergic reaction to thalidomide
- Uncontrolled systemic infection
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
Sweden9 sites
Department of Hematology and Coagulation, Sahlgrenska University hospital
Gothenburg, 413 45
Department of Hematology, Lund University Hospital
Lund, 221 85
Department of Hematology, Malmö University Hospital
Malmö, 205 02
Department of Medicine, Örebro University Hospital
Örebro, 701 85
Hematology Center, Karolinska University Hospital Huddinge
Stockholm, 141 86
Hematology Center, Karolinska University Hospital Solna
Stockholm, 171 76
Department of Medicine, Sundsvall Hospital
Sundsvall, 851 86
Department of Medicine, Umeå University Hospital
Umeå, 901 85
Department of Hematology, Akademiska University Hospital
Uppsala, 751 85
Denmark6 sites
Department of Hematology, Aalborg Hospital
Aalborg, 9000
Department of Hematology, Aarhus University Hospital
Aarhus, 8000
Department of Hematology, Rigshospitalet
Copenhagen, 2100
Department of Hematology, Herlev Hospital
Herlev, 2730
Department of Hematology, Odense University Hospital
Odense, 5000
Department of Hematology, Vejle Hospital
Vejle, 7100
Norway3 sites
Department of Hematology, Rikshospitalet University Hospital
Oslo, 0027
Department of Medicine, Ullevål Hospital
Oslo, 0407
Department of Hematology, Trondheim University Hospital
Trondheim, 7006
About this study
Official title: A Multicentre Phase II Study of the Efficacy and Safety of Lenalidomide in High-risk Myeloid Disease (High-risk MDS and AML) With a Karyotype Including Del(5q) or Monosomy 5
The aim of this study is to investigate the efficacy of lenalidomide in high risk MDS or AML with chromosome 5 aberrations.
Read the detailed description
Previous studies have shown that the immunomodulatory drug lenalidomide is effective in the treatment of low risk MDS with del(5q). Treatment of this subgroup of MDS patients resulted in 67% major erythroid responses and 45% complete cytogenetic responses. We therefore intend to test the efficacy of lenalidomide in a group of high-risk patients who are ineligible for conventional chemotherapy and who have a dismal prognosis. The patients must have a karyotype including del(5q) but patients with a karyotype including monosomy 5 are also eligible. We hypothesize that hight risk MDS or AML patients with other chromosomal aberrations than del(5q) can be affected by the lenalidomide effect.
- Being tested
- lenalidomide
- Keywords
- MDS, AML, Lenalidomide, monosomy 5, del5q
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Also called Revlimid
Initial dose is oral lenalidomide 10 mg daily continuously. The dose should be increased to 20 mg day 1 in week 6 and to 30 mg day 1 in week 10. This dose should be kept for seven weeks. Thus, the total study period is 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1. lenalidomide Receives: Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cytogenetic response (50% or more reduction of the del5(q) or monosomy 5 FISH positive clone in the bone marrow using the LSI EGR1/D5S23,D5S721 FISH probe) after 16 weeks of lenalidomide treatment
Measured: 16 weeks
Secondary outcomes (6)
Minor and complete cytogenetic (FISH) response after 8 and 16 weeks
Measured: 16 weeks
Red blood cell transfusion independence
Measured: 16 weeks
Erythroid response
Measured: 16 weeks
Bone marrow response (morphology)
Measured: 16 weeks
Modification of gene expression profiling during treatment
Measured: 16 weeks
Safety
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MDSStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic MDS Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Eva Hellström-Lindberg, MD, PhD, Principal investigator, Nordic MDS Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761449
- Sponsor's protocol ID
- NMDSG07A
- Other IDs
- EudraCT no: 2007-000450-31
- Status last verified
- Jan 2010
- First submitted
- 26 Sep 2008
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mollgard L, Saft L, Treppendahl MB, Dybedal I, Norgaard JM, Astermark J, Ejerblad E, Garelius H, Dufva IH, Jansson M, Jadersten M, Kjeldsen L, Linder O, Nilsson L, Vestergaard H, Porwit A, Gronbaek K, Hellstrom-Lindberg E. Clinical effect of increasing doses of lenalidomide in high-risk myelodysplastic syndrome and acute myeloid leukemia with chromosome 5 abnormalities. Haematologica. 2011 Jul;96(7):963-71. doi: 10.3324/haematol.2010.039669.
PubMed 21719884
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Phase II Study of the Efficacy and Safety of Lenalidomide in High-risk Myeloid Disease (High-risk MDS and AML) With a Karyotype Including Del(5q) or Monosomy 5
- ClinicalTrials.gov ID
- NCT00761449
- Acronym / sponsor ID
- NMDSG07A
- Keywords
- MDS, AML, Lenalidomide, monosomy 5, del5q
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nordic MDS GroupResearch network
- Study start
- Oct 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Sep 2008 (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 aim of this study is to investigate the efficacy of lenalidomide in high risk MDS or AML with chromosome 5 aberrations.
Detailed description
Previous studies have shown that the immunomodulatory drug lenalidomide is effective in the treatment of low risk MDS with del(5q). Treatment of this subgroup of MDS patients resulted in 67% major erythroid responses and 45% complete cytogenetic responses. We therefore intend to test the efficacy of lenalidomide in a group of high-risk patients who are ineligible for conventional chemotherapy and who have a dismal prognosis. The patients must have a karyotype including del(5q) but patients with a karyotype including monosomy 5 are also eligible. We hypothesize that hight risk MDS or AML patients with other chromosomal aberrations than del(5q) can be affected by the lenalidomide effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: lenalidomide1. lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must be >18 years of age at the time of signing the informed consent form
- MDS at IPSS Int-2 or High with a karyotype including del(5q) or monosomy 5 confirmed with FISH (using the LSI EGR1/D5S23,D5S721 FISH probe)
- Acute myeloid leukemia with a karyotype including del(5q) or monosomy 5 confirmed with FISH (using the LSI EGR1/D5S23,D5S721 FISH probe)
- Patients could be included if:
- At diagnosis and not considered eligible for induction chemotherapy
Key exclusion criteria (13 listed)
- Pregnant or lactating females.
- Prior therapy with lenalidomide
- Patients who are eligible for curative treatment
- Expected survival less than two months.
- Acute promyelocytic leukemia (APL)
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: RevlimidInitial dose is oral lenalidomide 10 mg daily continuously. The dose should be increased to 20 mg day 1 in week 6 and to 30 mg day 1 in week 10. This dose should be kept for seven weeks. Thus, the total study period is 16 weeks. | Drug | 1 |
Primary outcome
Major cytogenetic response (50% or more reduction of the del5(q) or monosomy 5 FISH positive clone in the bone marrow using the LSI EGR1/D5S23,D5S721 FISH probe) after 16 weeks of lenalidomide treatment
Time frame: 16 weeks
6 secondary outcomes
Minor and complete cytogenetic (FISH) response after 8 and 16 weeks
Time frame: 16 weeks
Red blood cell transfusion independence
Time frame: 16 weeks
Erythroid response
Time frame: 16 weeks
Bone marrow response (morphology)
Time frame: 16 weeks
Modification of gene expression profiling during treatment
Time frame: 16 weeks
Safety
Time frame: 16 weeks
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 Apr 2012.
- Derived from this study: PubMed 21719884Mollgard L, Saft L, Treppendahl MB, Dybedal I, Norgaard JM, Astermark J, Ejerblad E, Garelius H, Dufva IH, Jansson M, Jadersten M, Kjeldsen L, Linder O, Nilsson L, Vestergaard H, Porwit A, Gronbaek K, Hellstrom-Lindberg E. Clinical effect of increasing doses of lenalidomide in high-risk myelodysplastic syndrome and acute myeloid leukemia with chromosome 5 abnormalities. Haematologica. 2011 Jul;96(7):963-71. doi: 10.3324/haematol.2010.039669.
- Nordic MDS Group websiteLink provided by the sponsor.
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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.
Eva Hellström-Lindberg, MD, PhD principal investigator
Nordic MDS Group
18 sites in 3 countries: 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 MDS and AML, run by Nordic MDS Group at 18 sites in 3 countries.
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 11 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 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Sweden, Denmark, Norway. 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?
Major cytogenetic response (50% or more reduction of the del5(q) or monosomy 5 FISH positive clone in the bone marrow using the LSI EGR1/D5S23,D5S721 FISH probe) after 16 weeks of lenalidomide treatment (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00761449, which also lists 1 linked publication.
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 Apr 2012.