Myelodysplastic Syndrome(MDS) / Acute Myeloid Leukemia(AML) MedDRA version: 9.1 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome
Conditions
Interventions
Trade Name: Lenalidomide (Revlimid®)
Pharmaceutical Form: Capsule*
Sponsors
Groupe Francophone des Myélodysplasies (GFM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1.Age = 18 years 2.Must understand and voluntarily sign an informed consent form 3.Must be able to adhere to the study visit schedule and other protocol requirements 4.No contra indication to anthracycline based chemotherapy 5.Documented diagnosis of MDS, or CMML with WBC =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1.Pregnant or lactating females. 2.Contra indication to anthracycline based chemotherapy. 3.Proliferative (WBC = 13,000/mL) CMML. 4.Prior = grade-2 NCI CTCAE (v 3.0) allergic reaction to thalidomide. 5.Prior desquamating (blistering) rash while taking thalidomide. 6.Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for = 3 years. 7.Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days . 8.Less than 6 months since prior allogeneic bone marrow transplantation. 9.Less than 3 months since prior autologous bone marrow or stem cell transplantation. 10.Recombinant human erythropoietin (rHuEPO) therapy received within 28 days. 11.Known HIV-1 positivity. 12.Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study. 13.Creatinine Clearance< 50 ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this trial, we will test the combination of escalating doses of chemotherapy (starting at relatively low dose) with lenalidomide in intermediate-2-or high risk MDS and AML with del 5 q31. It is hoped that this combined therapy will further increase response rate in intermediate-2-or high risk MDS and AML with del 5 q31, without major toxicity in comparison to historical results obtained with chemotherapy alone in the same subset of patients ;Secondary Objective: Secondary objectives of the trial: will be duration of response, progression to AML, survival and safety of the combination of lenalidomide and chemotherapy.;Primary end point(s): The primary endpoint : will be response (CR, mCR and Cri, according to IWG criteria for AML and IWG 2006 criteria for MDS) to the combination of lenalidomide and chemotherapy in adult high and int 2 MDS (IPSS) or AML with deletion 5q[31] | — |
Countries
France
Outcome results
None listed