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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Secondary ID [1] 0 0
06/49
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelodysplasia 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Toxicity as defined by NCI-CTCv3.0
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Response
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Pharmacodynamics
Timepoint [2] 0 0
defined in protocol
Secondary outcome [3] 0 0
Change in Biomarkers
Timepoint [3] 0 0
defined in protocol

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2014
Actual
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Celgene Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00434239
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Miles Prince, Prof.
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00434239