Status:
UNKNOWN
Lenalidomide and Recombinant Human Stem Cell Factor for Treatment of Myelodysplasia
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Collaborating Sponsors:
Celgene Corporation
Conditions:
Myelodysplasia
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ha...
Detailed Description
Aim: The primary objective is to assess the safety of Revlimid in combination with Ancestim in patients with symptomatic myelodysplasia. The secondary objectives are: Duration of response and assessme...
Eligibility Criteria
Inclusion
- Understand and voluntarily sign an informed consent form.
- Age \>18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- 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.
- The patients must have either:
- symptomatic anemia as defined as Hb \< 10g/dl OR
- transfusion-dependent anaemia as defined as requiring more than 4 units of packed red blood cells over 8 weeks
- 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.
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- 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.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of Revlimid or SCF.
- Concurrent use of other anti-cancer agents or treatments including erythropoietin.
- Known positive for HIV or infectious hepatitis, type B or C.
- Mast cell diseases (systemic mastocytosis, urticaria pigmentosa or diffuse cutaneous mastocytosis)
- History of severe anaphylaxis, asthma, recurrent urticaria, recurrent angiooedema
- Known hypersensitivity against to Escherichia coli derived products.
- Prior chemotherapy or stem cell transplantation for the treatment of myelodysplasia.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00434239
Start Date
February 1 2007
End Date
May 1 2014
Last Update
January 10 2013
Active Locations (1)
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1
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002