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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00434239
Registration number
NCT00434239
Ethics application status
Date submitted
11/02/2007
Date registered
13/02/2007
Date last updated
10/01/2013
Titles & IDs
Public title
Lenalidomide and Recombinant Human Stem Cell Factor for Treatment of Myelodysplasia
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Scientific title
A Pilot Study of the Combination of Lenalidomide (Revlimid®) With Two Different Dose Levels of Short Term Administration of Recombinant Human Stem Cell Factor (rhSCF; Ancestim) for Myelodysplasia.
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Secondary ID [1]
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06/49
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myelodysplasia
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide + Ancestim
Experimental: Treatment: Lenalidomide and Ancestim - Drug: Lenalidomide + Ancestim Dose level 1. Lenalidomide 10mg orally daily days 1-21/ 28 day cycle Ancestim 10mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle. Dose level 2 Ancestim 20mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle
Treatment: Drugs: Lenalidomide + Ancestim
Dose level 1. Lenalidomide 10mg orally daily days 1-21/ 28 day cycle Ancestim 10mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle. Dose level 2 Ancestim 20mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Toxicity as defined by NCI-CTCv3.0
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Assessment method [1]
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Response
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Assessment method [1]
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Pharmacodynamics
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Assessment method [2]
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Timepoint [2]
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defined in protocol
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Secondary outcome [3]
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Change in Biomarkers
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Assessment method [3]
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Timepoint [3]
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defined in protocol
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Eligibility
Key inclusion criteria
1. Understand and voluntarily sign an informed consent form.
2. Age >18 years at the time of signing the informed consent form.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Patients must have a confirmed myelodysplastic syndrome regardless of subgroup
according to the WHO classification and their prognostic group. Patients with
treatment associated MDS are allowed on this study, however the number is restricted
to 10 (50% of patients anticipated to receive combination treatment). Patients with
CMML are eligible but restricted in number to up to 3 in total.
5. The patients must have either:
1. symptomatic anemia as defined as Hb < 10g/dl OR
2. transfusion-dependent anaemia as defined as requiring more than 4 units of packed
red blood cells over 8 weeks
6. All previous cancer therapy, including erythropoietin, thalidomide and other
experimental therapies must have been discontinued at least 4 weeks prior to treatment
in this study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
2. Pregnant or lactating females.
3. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.
4. Use of any other experimental drug or therapy within 28 days of baseline.
5. Known hypersensitivity to thalidomide.
6. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.
7. Any prior use of Revlimid or SCF.
8. Concurrent use of other anti-cancer agents or treatments including erythropoietin.
9. Known positive for HIV or infectious hepatitis, type B or C.
10. Mast cell diseases (systemic mastocytosis, urticaria pigmentosa or diffuse cutaneous
mastocytosis)
11. History of severe anaphylaxis, asthma, recurrent urticaria, recurrent angiooedema
12. Known hypersensitivity against to Escherichia coli derived products.
13. Prior chemotherapy or stem cell transplantation for the treatment of myelodysplasia.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 0
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2014
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Actual
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Sample size
Target
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - East Melbourne
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Celgene Corporation
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is mainly assessing the safety of Revlimid in combination with Ancestim
(recombinant human stem cell factor) in patients with symptomatic myelodysplasia. Of those
two compounds, Revlimid has been shown to be an active drug in myelodysplasia. Clinical
responses will also be assessed.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00434239
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miles Prince, Prof.
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Address
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Peter MacCallum Cancer Centre, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00434239
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