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A Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion-dependent Subjects With Myelodysplastic Syndromes Associated With a Del(5q) Cytogenetic Abnormality.


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

Thank you

Trial Information

A Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion-dependent Subjects With Myelodysplastic Syndromes Associated With a Del(5q) Cytogenetic Abnormality.


Inclusion Criteria:



- Must understand and voluntarily sign an informed consent form

- Age 18 years or older at the time of signing the informed consent

- Must be able to adhere to the study visit schedule and other protocol requirements.

- Diagnosis of low or intermediate-1-risk International Prognostic Scoring System
(IPSS) Myelodysplastic Syndromes (MDS) without an abnormality of chromosome 5
involving a deletion between bands q31 and q33.

- Red blood cell (RBC) transfusion-dependent anemia defined as having received greater
than or equal to 2 units of RBCs within 8 weeks of the first day of study drug
treatment.

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
test within 7 days of starting study drug.

- Sexually active WCBP must agree to use adequate contraceptive methods (oral,
injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine
device; barrier contraceptive with spermicide; or vasectomized partner) while on
study drug.

- WCBP must agree to have pregnancy tests every 4 weeks while on study drug.

Exclusion Criteria:

- Pregnant or lactating females

- Prior therapy with lenalidomide.

- An abnormality of chromosome 5 involving a deletion between bands q31 and q33.

- Lab Abnormality: Absolute neutrophil count (ANC) <500 cell/mm^3 (0.5*10^9/L)

- Lab Abnormality: Platelet count <50,000/mm^3 (50*10^9/L)

- Lab Abnormality: Serum creatinine >2.5 mg/dL (221 mmol/L)

- Lab Abnormality: Serum total bilirubin >2.0 mg/dL (34 mmol/L)

- Prior greater than or equal to grade 3 National Cancer Institute (NCI) Common
Toxicity Criteria (CTC) allergic reaction/hypersensitivity to thalidomide.

- Clinically significant anemia due to factors such as iron, B12 or folate
deficiencies, autoimmune or hereditary hemolysis or gastrointestinal bleeding

- If a marrow aspirate is not evaluable for storage iron, transferrin saturation must
be > 20% and serum ferritin not less than 50 ng/mL

- Use of hematopoietic growth factors within 7 days of the first day of study drug
treatment.

- Prior greater than or equal to grade 3 NCI CTC rash or any desquamation (blistering)
while taking thalidomide.

- Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent
(dose equivalent to >10 mg/day of prednisone) within 28 days of the first day of
study drug treatment.

- Use of experimental or standard drugs (i.e. chemotherapeutic, immunosuppressive, and
cytoprotective agents) for the treatment of MDS within 28 days of the first day of
study drug treatment.

- 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 greater than or equal to 3 years.

- Use of any other experimental therapy within 28 days of the first day of study drug
treatment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence

Outcome Description:

Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin.

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Alan F List, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-MDS-003

NCT ID:

NCT00065156

Start Date:

June 2003

Completion Date:

August 2008

Related Keywords:

  • Myelodysplastic Syndromes
  • MDS
  • CC-5013
  • Revlimid
  • Celgene
  • Congenital Abnormalities
  • Chromosome Aberrations
  • Chromosome Disorders
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Stanford University Medical CenterStanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Swedish Cancer InstituteSeattle, Washington  98104
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Mayo ClinicJacksonville, Florida  32224
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
Oregon Health & Science UniversityPortland, Oregon  97201
University of Chicago Medical CenterChicago, Illinois  60637
Midwest Cancer Research GroupSkokie, Illinois  60077
Mayo ClinicScottsdale, Arizona  
The Cleveland Clinic FoundationCleveland, Ohio  
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
Cancer & Blood Disease CenterLecanto, Florida  34461
Northwest Georgia Oncology - Wellstar Cancer ResearchMarietta, Georgia  30060
Wayne State University School of MedicineDetroit, Michigan  48201-2097
Mt. Sinai Medical CenterNew York, New York  10029
Kaiser Permanente Northwest RegionPortland, Oregon  97227
Desert Hematology & Oncology Medical GroupRancho Mirage, California  92270
University of Miami Sylvester Comp Cancer CenterMiami, Florida  33136
Rush-Presbyterian- St. Luke's Medical CenterChicago, Illinois  60612
New York Hospital-CornellNew York, New York  10021-0034
University of Rochester- James P. Wilmot Cancer CenterRochester, New York  14642