Lenalidomide and Recombinant Human Stem Cell Factor for Treatment of Myelodysplasia

NCT00434239 | Unknown Early Phase 1 DMC

• 1 other identifier: 06/49
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplasia

Keywords

Myelodysplasia; Lenalidomide; Ancestim; Pilot trial; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Toxicity as defined by NCI-CTCv3.0

  3 years

Secondary Outcomes (3)

• Response

  3 years

• Pharmacodynamics

  defined in protocol

• Change in Biomarkers

  defined in protocol

Study Arms (1)

Treatment: Lenalidomide and Ancestim

EXPERIMENTAL

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

Drug: Lenalidomide + Ancestim

Interventions

Lenalidomide + Ancestim DRUG

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

Also known as: Revlimid, rhSCF

Treatment: Lenalidomide and Ancestim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• Celgene Corporation: collaborator

Study Sites (1)

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Anemia, Refractory, with Excess of Blasts

Interventions

Lenalidomide; ancestim

Condition Hierarchy (Ancestors)

Anemia, Refractory; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Miles Prince, Prof.

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2007
• First Posted: February 13, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2014
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

AU (1)