Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Alemtuzumab and Cyclosporine in Treating Patients With Myelodysplastic Syndromes
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00217594
  Purpose

RATIONALE: Immunosuppressive therapy with alemtuzumab and cyclosporine may improve bone marrow abnormalities and may be an effective treatment for myelodysplastic syndromes.

PURPOSE: This phase I/II trial is studying the side effects of giving alemtuzumab together with cyclosporine and to see how well it works in treating patients with myelodysplastic syndromes.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: alemtuzumab
Drug: cyclosporine
Phase I
Phase II

MedlinePlus related topics: Anemia
Drug Information available for: Cyclosporin Cyclosporine Alemtuzumab Campath
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: A Pilot Study of Alemtuzumab (Campath®) in Patients With Myelodysplastic Syndrome (MDS)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Hematologic response (complete or partial) at 3 months after the first dose of alemtuzumab and sustained on ≥ 2 serial measurements performed 1 month apart [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transfusion independence for red blood cells and/or platelets [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Life-threatening toxicity [ Designated as safety issue: Yes ]
  • Overall survival and transformation-free survival [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: July 2005
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the efficacy and safety of alemtuzumab and cyclosporine on blood counts and transfusion requirements measured at 3 months in patients with myelodysplastic syndromes.

OUTLINE: This is a non-randomized, open-label, pilot study.

Patients receive a test dose of alemtuzumab IV over 1 hour. If tolerated, patients receive alemtuzumab IV over 2 hours once daily for 10 days. Patients are evaluated for response at 3 months. Patients with disease progression or no response are removed from the study. Patients with relapsing disease after initial response may receive cyclosporine for 2-3 months or longer at the discretion of the investigator.

After completion of study treatment, patients are followed at 3 and 6 months and then annually for up to 5 years.

PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of myelodysplastic syndromes (MDS), including the following subtypes:

    • Refractory anemia (RA)
    • RA with ringed sideroblasts (RARS)
    • Refractory cytopenia with multilineage dysplasia (RCMD)
    • RCMD and ringed sideroblasts (RCMD-RS)
    • RA with excess blasts (RAEB-1, < 5% blasts)
  • Meets 1 of the following hematologic parameters:

    • Anemia requiring transfusion support with ≥ 1 unit of packed red blood cells per month for ≥ 2 months accompanied with ≥ 1 of the following laboratory values:

      • Anemia, defined as hemoglobin < 9 g/dL OR reticulocyte count < 60,000/mm^3
      • Thrombocytopenia, defined as platelet count < 50,000/mm^3
      • Neutropenia, defined as absolute neutrophil count < 500/mm^3
  • Disease status must meet 1 of the following criteria:

    • No suitable sibling marrow donor match
    • Suitable sibling marrow match available, but patient refuses transplantation
    • Prior response to horse-antithymocyte globulin (h-ATG) or h-ATG with cyclosporine
  • No chronic myelomonocytic leukemia, RAEB-2 (5-19% blasts), or secondary MDS
  • Not refractory to prior ATG or ATG with cyclosporine
  • No transformation to acute leukemia (RAEB-T, > 20% blasts in marrow)
  • High or intermediate probability of response predicted

PATIENT CHARACTERISTICS:

Age

  • 18 to 72

Performance status

  • Not specified

Life expectancy

  • At least 6 months

Hematopoietic

  • See Disease Characteristics

Hepatic

  • No concurrent severe hepatic disease that would preclude study treatment

Renal

  • No concurrent severe renal disease that would preclude study treatment

Cardiovascular

  • No concurrent severe cardiac disease that would preclude study treatment

Pulmonary

  • No concurrent severe pulmonary disease that would preclude study treatment

Other

  • Not pregnant
  • No nursing during and for 3 months after the completion of study treatment
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • HIV negative
  • No active infection
  • No other malignancy except nonmelanoma skin cancer
  • No prior hypersensitivity to study drugs or its components
  • No concurrent severe neurologic, infectious, or metabolic disease that would preclude study treatment
  • No moribund status
  • No contact with anyone receiving oral polio vaccine

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 4 weeks since prior biologic therapy
  • Prior or concurrent filgrastim (G-CSF)*, epoetin alfa, or transfusion support allowed
  • No vaccine therapy during and for ≥ 1 year after completion of study treatment NOTE: *G-CSF can be used before, during, and after study treatment for patients with documented neutropenia < 500/mm3 as long as they meet the criteria for anemia and/or thrombocytopenia

Chemotherapy

  • At least 4 weeks since prior chemotherapy
  • No prior combination chemotherapy

Endocrine therapy

  • At least 4 weeks since prior hormonal therapy

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • At least 2 weeks since prior herbal supplements (e.g., Echinacea purpurea or Usnea barbata [Old Man's Beard])
  • No concurrent herbal supplements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217594

Locations
United States, Maryland
NIH - Warren Grant Magnuson Clinical Center Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Patient Recruitment     800-411-1222        
Sponsors and Collaborators
Investigators
Principal Investigator: Elaine Sloand, MD National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: NHLBI - Hematology Branch ( Elaine Sloand )
Study ID Numbers: CDR0000442361, NHLBI-05-H-0206
Study First Received: September 20, 2005
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00217594  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
refractory anemia with excess blasts
refractory anemia with ringed sideroblasts
refractory anemia
refractory cytopenia with multilineage dysplasia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes

Study placed in the following topic categories:
Myelodysplastic syndromes
Cyclosporine
Precancerous Conditions
Clotrimazole
Hematologic Diseases
Refractory anemia
Miconazole
Myelodysplastic Syndromes
Myelodysplasia
Tioconazole
Anemia
Cyclosporins
Preleukemia
Anemia, Refractory
Alemtuzumab
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
Disease
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Pathologic Processes
Syndrome
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 30, 2009