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Lenalidomide After Failure of Hypomethylating Agents in Myelodysplastic Syndrome (VIOLET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01673308
Recruitment Status : Unknown
Verified May 2016 by Hawk Kim, Ulsan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2012
Last Update Posted : May 11, 2016
Cooperative Study Group A for Hematology
Information provided by (Responsible Party):
Hawk Kim, Ulsan University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: Lenalidomide Phase 2

Detailed Description:
There is no standard therapy after the failure of hypomethylating agents only providing supportive cares including transfusion or cytokine therapies. Lenalidomide is the treatment of choice in case of MDS with 5q deletion. A study of lenalidomide for non-5q deletion MDS patients showed that transfusion independency rate was 26% which was relatively acceptable and suggested that lenalidomide could be used for non-5q deletion MDS patients. There is no datum for second-line lenalidomide therapy after hypomethylating agents. MDS which has highly complex pathogenesis backgrounds will have distinctive subtype for each therapy and each treatment drug can have distinctive subgroup for the response. In fact the investigators don't know which patient will be responsive hypomethylating agents or lenalidomide except for 5q deletion. This suggests that second line therapy after the first line failure in MDS will be different with other type of relapsed/refractory disease which will be tend to more resistant to subsequent therapies. In this regard, there is a possibility to have a relatively high response rate to second line lenalidomide in this selected subset who has failed to the hypomethylation therapy or some patients will be responsive regardless of treatment line. Recent data suggested that MDS with JAK2 mutation will be responsive to lenalidomide. The investigators will analyze the JAK2 mutation status in response evaluation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salvage in Patients With Myelodysplastic Syndrome After Failure of Hypomethylating Agents: Lenalidomide as a Second-line Therapy
Study Start Date : August 2012
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment arm
Lenalidomide treatment arm
Drug: Lenalidomide
Lenalidomide 10 mg orally on days 1 to 21 of a 28-day cycle for at least 4 cycles until intolerance or disease progression.
Other Name: Revlimid

Primary Outcome Measures :
  1. Response criteria by international working group (IWG) 2006 criteria [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 2 years ]
    Safety assessed by national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01673308

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Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of, 682714
Sponsors and Collaborators
Ulsan University Hospital
Cooperative Study Group A for Hematology
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Principal Investigator: Hawk Kim, M.D., Ph.D. Ulsan University Hospital, University of Ulsan College of Medicine

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Responsible Party: Hawk Kim, Associate Professor, Ulsan University Hospital Identifier: NCT01673308    
Other Study ID Numbers: RV-MDS-PI-0722
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Immunologic Factors
Physiological Effects of Drugs
Growth Substances
Growth Inhibitors
Antineoplastic Agents