Lenalidomide and Recombinant Human Stem Cell Factor for Treatment of Myelodysplasia

• Status: Unknown status
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter MacCallum Cancer Centre, Australia
• Collaborator: Celgene Corporation
• Treatments: Lenalidomide; Thalidomide

Criteria

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.

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.