Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes

Lead Sponsor:

Mikkael Sekeres MD

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Leukemia

Myelodysplastic Syndromes

Eligibility:

All Genders

18-120 years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer cells from growing...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of lenalidomide and azacitidine in patients with advanced myelodysplastic syndromes (MDS). Secondary * Review ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of myelodysplastic syndromes (MDS) meeting one of the following criteria:
  • French-American-British histological classification criteria
  • Refractory anemia with excess blasts (RAEB), defined as 5-19% myeloblasts in the bone marrow
  • Patients with 20% blasts are considered to have acute myeloid leukemia (per WHO classification system) and are therefore excluded in this study
  • Chronic myelomonocytic leukemia (CMML), defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood
  • WHO histological classification criteria
  • RAEB-1, defined as 5-9% myeloblasts in the bone marrow
  • RAEB-2, defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood
  • CMML-2, defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood
  • International Prognostic Scoring System (IPSS) score of intermediate 2 (1.5-2.0 points based on karyotype, cytopenias, and bone marrow blast percentage) or high (≥ 2.5 points), in the setting of ≥ 5% myeloblasts
  • Considered ineligible for bone marrow transplantation as first-line therapy
  • PATIENT CHARACTERISTICS:
  • Life expectancy ≥ 3 months
  • ECOG performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception for 4 weeks before, during, and for 4 weeks after completion of study treatment
  • No serious medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the treating physician, would preclude study participation or preclude giving informed consent
  • No preexisting neurotoxicity or neuropathy ≥ grade 2
  • No rash or prior hypersensitivity or allergic reaction ≥ grade 3 to thalidomide
  • Creatinine ≤ 2.0 mg/dL
  • AST and ALT ≤ 2.0 times upper limit of normal
  • Bilirubin ≤ 2 mg/dL
  • Platelet count ≥ 50,000/mm\^3
  • Absolute neutrophil count ≥ 500/mm\^3
  • No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No history of thromboembolic event or other condition requiring use of anticoagulation with warfarin or low molecular-weight heparin
  • No known or suspected hypersensitivity to azacitidine or mannitol
  • PRIOR CONCURRENT THERAPY:
  • More than 28 days since prior and no other concurrent investigational agents for MDS
  • More than 28 days since prior approved therapy for MDS
  • More than 14 days since prior growth factors
  • More than 28 days since prior and no concurrent supraphysiologic doses (equivalent to \> 10 mg/day of prednisone) of corticosteroids
  • More than 12 months since prior radiotherapy, chemotherapy, or cytotoxic therapy for treatment of conditions other than MDS
  • No prior lenalidomide or azacitidine
  • No prior stem cell or bone marrow transplantation
  • No concurrent androgens, epoetin alfa, or chemotherapy for MDS

Exclusion

    Key Trial Info

    Start Date :

    May 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2011

    Estimated Enrollment :

    37 Patients enrolled

    Trial Details

    Trial ID

    NCT00352001

    Start Date

    May 1 2006

    End Date

    September 1 2011

    Last Update

    September 19 2018

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    University of California at Los Angeles

    Los Angeles, California, United States, 90095-1781

    2

    H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, United States, 33612-9497

    3

    Cleveland Clinic Taussig Cancer Instititute, Case Comprehensive Cancer Center

    Cleveland, Ohio, United States, 44195