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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 Center Tucson, Arizona  85724
MD Anderson Cancer Center Houston, Texas  77030-4096
Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Rochester, Minnesota  55905
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Stanford University Medical Center Stanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Johns Hopkins Oncology Center Baltimore, Maryland  21287
Swedish Cancer Institute Seattle, Washington  98104
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Mayo Clinic Jacksonville, Florida  32224
Western Pennsylvania Cancer Institute Pittsburgh, Pennsylvania  15224
Oregon Health & Science University Portland, Oregon  97201
University of Chicago Medical Center Chicago, Illinois  60637
Midwest Cancer Research Group Skokie, Illinois  60077
Mayo Clinic Scottsdale, Arizona  
The Cleveland Clinic Foundation Cleveland, Ohio  
Wake Forest University School of Medicine Winston-Salem, North Carolina  27157-1023
Cancer & Blood Disease Center Lecanto, Florida  34461
Northwest Georgia Oncology - Wellstar Cancer Research Marietta, Georgia  30060
Wayne State University School of Medicine Detroit, Michigan  48201-2097
Mt. Sinai Medical Center New York, New York  10029
Kaiser Permanente Northwest Region Portland, Oregon  97227
Desert Hematology & Oncology Medical Group Rancho Mirage, California  92270
University of Miami Sylvester Comp Cancer Center Miami, Florida  33136
Rush-Presbyterian- St. Luke's Medical Center Chicago, Illinois  60612
New York Hospital-Cornell New York, New York  10021-0034
University of Rochester- James P. Wilmot Cancer Center Rochester, New York  14642