Lenalidomide After Failure of Hypomethylating Agents in Myelodysplastic Syndrome

• Status: Unknown status
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II study to evaluate the efficacy of second-line lenalidomide monotherapy for myelodysplastic syndrome (MDS) patients who failed to hypomethylating agents.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ulsan University Hospital
• Collaborator: Cooperative Study Group A for Hematology
• Treatments: Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Myelodysplastic syndrome by world health organization (WHO) classification

• Treatment failure after hypomethylating agents (HMA; azacitidine or decitabine); Intolerant to hypomethylating agents or Progressive disease after HMA

• Age over 18 years old

• Eastern Cooperative Oncology Group (ECOG) performance status ≤2

• Adequate organ function (serum creatinine ≤ 2.5 mg/dL, serum aspartate transaminase or alanine transaminase ≤ 3.0 x upper limit of normal (ULN), and serum direct bilirubin ≤ 2.0 mg/dL).

Exclusion Criteria:

• Previous therapy history for MDS except for hypomethylating agents, cytokines (granulocyte-stimulating agents or erythropoietin) or supportive care.

• Patients who cannot keep the strict contraception or who willing to be pregnant.

• Contraindication to lenalidomide: Females who are or may become pregnant; Lenalidomide is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components; Lenalidomide capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

• Patients who cannot take lenalidomide orally

• Current enrollment to other clinical trial

• Presence of uncontrolled bleeding

• Severe or life-threatening other medical conditions

• Any coexisting major illness or organ failure

• Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible

• History of congenital or acquired coagulopathy unrelated to malignancy

• History of non-compliance or patient who cannot sign informed consent

• Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)

• Candidate of hematopoietic stem cell transplantation who cannot complete 4 cycles of lenalidomide.