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The Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion Dependent Subjects With Myelodysplastic Syndrome (MDS) Associated With Del (5q) Abnormality

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by King's College Hospital NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT00874978
First received: March 16, 2009
Last updated: April 2, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to evaluate the efficacy of lenalidomide treatments to achieve haematopoietic improvement in subjects with low- or intermediate-1 risk International Prognostic Scoring System1 (IPSS) myelodysplastic syndrome (MDS) associated with a del (5q31-33) cytogenetic abnormality.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Lenalidomide (Revlimid®) Monotherapy in Red Blood Cell Transfusion Dependent Subjects With Myelodysplastic Syndrome Associated With Del (5q) Cytogenetic Abnormality

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • Red blood cell (RBC) transfusion independence. [ Time Frame: monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cytogenetic response [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Over or equal to 50% decrease in RBC transfusion requirements [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Change of haemoglobin concentration from baseline [ Time Frame: every 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Safety (type, frequency, severity, and relationship of adverse events to lenalidomide) [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • Platelet response [ Time Frame: every 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Neutrophil response [ Time Frame: every 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Bone marrow response [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Gene expression profiling of patients with the 5q- syndrome and effects of lenalidomide on gene expression profiles [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2005
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lenalidomide Drug: lenalidomide
Oral lenalidomide 10mg (two 5mg capsules) daily on days 1-21 every 28 days for up to 6 cycles.
Other Names:
  • Revlimid
  • CC-5013

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age over or equal to 18 years at the time of signing the informed consent form.
  3. Able to adhere to the study visit schedule and other protocol requirements.
  4. Diagnosis of low- or intermediate-1-risk (IPSS) MDS associated with a del(5q) cytogenetic abnormality. The cytogenetic abnormality of chromosome 5 must involve a deletion between bands q31 and q33. The del(5q) cytogenetic abnormality may be an isolated finding or may be associated with other cytogenetic abnormalities.
  5. RBC transfusion-dependent anaemia defined as having no transfusion free interval of < 56 consecutive days within the past 112 days.
  6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
  7. Women of childbearing potential (WCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
  8. Laboratory test results within these ranges:

    • Absolute neutrophil count over or equal to 0.5 x 109/L
    • Platelet count over or equal to 25 x 109/L
    • Serum creatinine under or equal to 2.0 mg/dl
    • Total bilirubin under or equal to 1.5 mg/dl
    • AST (SGOT) and ALT (SGPT) under or equal to 3 x ULN.
  9. Disease free of prior malignancies for over or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast.

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or lactating females.
  3. Prior > grade 3 (National Cancer Institute [NCI] Common Toxicity Criteria [CTC]) allergic reaction to thalidomide.
  4. Prior > grade 3 (NCI CTC) rash or any desquamation (blistering) while taking thalidomide.
  5. Clinically significant anaemia due to factors such as iron, B12 or folate deficiencies,autoimmune or hereditary haemolysis 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).
  6. Use of haematopoietic growth factors within 7 days of the first day of study drug treatment. Use of G-CSF is permitted.
  7. Concurrent use of erythropoietin
  8. Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to >10 mg/day of prednisolone) within 28 days of the first day of study lenalidomide treatment.
  9. 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 lenalidomide treatment.
  10. 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 >3 years.
  11. Any prior use of lenalidomide.
  12. Concurrent use of other anti-cancer agents or treatments. Patients must not have received any form of chemotherapy for at least 4 weeks prior to study entry and must have fully recovered from haematological toxicity associated with this therapy.
  13. Known positive for HIV or infectious hepatitis, type A, B or C.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874978

Contacts
Contact: Ghulam J Mufti, MB, DM, FRCP, FRCPath +44 (0) 20 3299 9000 ext 3238 ghulam.mufti@kcl.ac.uk

Locations
United Kingdom
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Contact: Ghulam J Mufti, MB, DM, FRCP, FRCPath    +44 (0) 20 3299 9000 ext 3238    ghulam.mufti@kcl.ac.uk   
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: Ghulam J Mufti, MB, DM, FRCP, FRCPath King's College London
  More Information

No publications provided

Responsible Party: Professor Ghulam Mufti, King's College London
ClinicalTrials.gov Identifier: NCT00874978     History of Changes
Other Study ID Numbers: 04CC06, REC - 04/Q0703/148, EudraCT - 2004-005101-29
Study First Received: March 16, 2009
Last Updated: April 2, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by King's College Hospital NHS Trust:
Lenalidomide
myelodysplastic syndromes

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014