Lenalidomide for Myelodysplastic Syndrome Refractory to Hypomethylating Agents

NCT01246076 | Completed Phase 2 Results

• 1 other identifier: 201011810
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the proportion of confirmed responses (complete response, partial response, and hematologic improvement as defined by revised IWG criteria during the 12 months of treatment.

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Confirmed Responses (Complete Remission, Partial Remission, or Hematologic Improvement) as Defined by the International Working Group Criteria

  * Complete remission (CR): ≤5% myeloblasts bone marrow blasts, normal maturation in all cell lines (dysplasia will be noted), ≥11 g/dl peripheral blood hemoglobin, ≥100x10\^9cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood absolute neutrophil count (ANC), and 0% peripheral blood blasts. * Marrow complete remission (MCR): ≤5% myeloblasts and decreased by ≥50% compared to pre-treatment bone marrow blasts, bone marrow morphology not relevant, and peripheral blood (if hematological improvement they will be noted in addition to marrow CR). * Partial remission (PR): previously had ≥5% myeloblasts and now have ≥5% myeloblasts but decreased by ≥50% compared to pre-treatment, bone marrow morphology not relevant, ≥11 g/dl peripheral blood hemoglobin, ≥100x109cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood ANC, and 0% peripheral blood blasts

  Up to 56 weeks (14 cycles of treatment)

Secondary Outcomes (5)

• Overall Survival Rate

  6 months after end of treatment (up to 82 weeks from start of treatment)

• Duration of Response

  Until 6 months after end of treatment

• Time to Discontinuation of Treatment

  Up to 56 weeks (14 cycles)

• Toxicity as Measured by Number of Participants Who Experienced Related Grade 3-5 Adverse Events Based on CTCAE Version 4

  30 days after end of treatment (up to 60 weeks)

• Time to Progression

  Up to 6 months after completion of treatment (up to 82 weeks from start of treatment)

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Lenalidomide 50 mg/day for two 28 day cycles. Patients who have bone marrow aplasia as defined by a cellularity of \<10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Also known as: Revlimid

Lenalidomide

Eligibility Criteria

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

You may qualify if:

• Patient must be able to understand and voluntarily sign an informed consent form.
• Patient must be ≥ 18 years old.
• Patient must be able to adhere to the study visit schedule and other protocol requirements.
• Patient must have histologically confirmed Myelodysplastic Syndrome as defined by FAB Classification including CMML and secondary MDS which has either:
• progressed at any time during treatment with hypomethylating agents
• failed to achieve a response after 6 cycles
• progressed after treatment with hypomethylating agents had been discontinued Criteria for response and for progression as defined by revised IWG criteria
• Patient must have discontinued all previous cancer therapy, including radiation, hormonal therapy and surgery at least 4 weeks prior to treatment in this study.
• Patient must have an ECOG performance status of ≤ 2 at study entry
• Patient must have laboratory test results within these ranges:
• calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula
• total bilirubin ≤ 1.5 x ULN
• AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
• Patient must be disease free of prior malignancies for at least 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
• Patient must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS®.

You may not qualify if:

• Patient must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Patient must not be pregnant or breastfeeding.
• Patient must not have 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.
• Patient must not use any other experimental drug or therapy within 28 days of baseline.
• Patient must not have a known hypersensitivity to thalidomide.
• Patient must not have developed of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Patient must not have any prior use of lenalidomide.
• Patient must not be concurrently using other anti-cancer agents or treatments.
• Patient must not have known seropositivity for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Mayo Clinic Scottsdale AZ

Scottsdale, Arizona, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic 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

Results Point of Contact

• Title: Ravi Vij, M.D.
• Organization: Washington University School of Medicine

rvij@dom.wustl.edu

314-454-8304

Study Officials

• Ravi Vij, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 23, 2010
• Study Start: June 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2015
• Last Updated: January 5, 2016
• Results First Posted: January 5, 2016

Record last verified: 2015-11

Locations

US (2)