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A Phase II Study of Antithymocyte Globulin (ATG) and Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome (MDS)


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

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Trial Information

A Phase II Study of Antithymocyte Globulin (ATG) and Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome (MDS)


A growing body of laboratory and clinical evidence suggests that the cytopenia of MDS is at
least partly a result of cytotoxic T cell activity. Treatments to abrogate T cell activity
such as anti-thymocyte globulin alone and cyclosporine alone have demonstrated varying
degrees of success in alleviating the cytopenia of MDS. A response to such therapy in MDS
is associated with improved survival. Experience with aplastic anemia suggests that the
combination of these two agents should be more effective in suppressing cytotoxic T cell
activity and alleviating cytopenia. This protocol proposes using the combination of
antithymocyte globulin (ATG) and cyclosporine (CSA) to treat the cytopenia of MDS, in an
effort to improve the response rate to immunosuppressive therapy in this disease.

Inclusion Criteria


- INCLUSION CRITERIA:

MDS of RA, RARS & RAEB sub-types

Off all other treatments (except G-CSF, and transfusion support and related medications)
for at least four weeks.

G-CSF can be used before, during and after the protocol treatment for patients with
documented neutropenia (less than 500/uL) as long as they meet the criteria for anemia
and/or thrombocytopenia as stated above.

ECOG performance status of 2 or less

High or intermediate predcted probability of response

EXCLUSION CRITERIA:

MDS of FAB sub-group chronic myelomonocytic leukemia (CMML)

Transformation to acute leukemia (FAB sub-group RAEB-T, ie., greater than 20% blasts in
marrow aspirate)

Hypoplastic marrow without one major or two minor criteria

Treatment with growth factors (except for G-SCF) or cyclosporine within 4 weeks prior to
entry to protocol

ECOG performance status of greater than 2

Active uncontrolled infection

Current pregnancy, or unwilling to take oral contraceptives if of childbearing potential

Patients for whom bone marrow transplant is indicated as standard therapy (age less than
fifty-five with a fully-matched sibling donor)

Age less than18 years

Not able to give informed consent

HIV positive patients

Active malignant disease (excluding basal cell carcinoma)

Serum creatinine greater than 2mg/dl

Patients who are moribund or patients with concurrent hepatic, renal, cardiac, metabolic,
or any disease of such severity that death within 3 months is likely

Low predicted probability of response

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:

Transfusion-independence

Outcome Time Frame:

6-months

Safety Issue:

Yes

Authority:

United States: Federal Government

Study ID:

000169

NCT ID:

NCT00005937

Start Date:

June 2000

Completion Date:

March 2008

Related Keywords:

  • Myelodysplastic Syndrome
  • MDS
  • Immunosuppression
  • ATG
  • Cyclosporine
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892