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A Phase 2, Single Arm Study to Determine the Safety and Efficacy of Azacitidine, and Thalidomide in Higher Risk Myelodysplastic Syndrome


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

Thank you

Trial Information

A Phase 2, Single Arm Study to Determine the Safety and Efficacy of Azacitidine, and Thalidomide in Higher Risk Myelodysplastic Syndrome


Inclusion Criteria:



- Patient is, in the investigator(s) opinion, willing and able to comply with the
protocol requirements.

- Patient has given voluntary written informed consent before performance of any
study-related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the patient at any time without prejudice to their future
medical care.

- Patient is older than 18 years at the time of signing the informed consent.

- Female patient is either post-menopausal or surgically sterilized or willing to use
an acceptable double method of birth control (i.e., a hormonal contraceptive,
intrauterine device, diaphragm with spermicide, condom with spermicide, or
abstinence) for the duration of the study.

- Female of childbearing potential must have a negative serum β-human chorionic
gonadotropin ( beta sub unit-HCG) pregnancy test both 24 hours prior to beginning of
therapy and then at 4 weeks intervals in women with regular menstrual cycles or every
2 weeks in women with irregular menstrual cycles during study treatment for subjects
of childbearing potential.

- Male patient agrees to use an acceptable method for contraception (i.e., condom or
abstinence) during study drug therapy (including dose interruption) and for 4 weeks
after discontinuation of thalidomide therapy.

- Patient was diagnosed with myelodysplastic syndrome INT-2 or High risk according IPSS
score .Bone marrow aspiration examination including cytogenetics performed up to 12
months before patient signing informed consent.

- Patient has a Performance Status 0-2 (WHO).

- Patient has a life-expectancy > 6 months

- Patient has not known active infectious hepatitis type B or C, or HIV infection.

- Patient is epopoietin resistant. Erythropoietin should be discontinued 28 days before
starting treatment period.

- Patient has the following laboratory values within 14 days before Baseline (day 1 of
the Cycle 1):

- Platelet count ≥ 25 x 109/L without transfusion support within 7 days before the
test.

- Absolute neutrophil count (ANC) ≥ 0.5 x 109/L without the use of growth factors.

- Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN).

- Alanine transaminase (ALT): ≤ 2.5 x the ULN.

- Total bilirubin: ≤ 1.5 x the ULN.

- Serum creatinine< 2 X the ULN.

Exclusion Criteria:

-

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate measured by complete blood counts and bone marrow examinations

Outcome Time Frame:

at study entry. after 6 months and after one year

Safety Issue:

No

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

TASMC-08-MM-TLV-0069-08-CTIL

NCT ID:

NCT00704704

Start Date:

September 2008

Completion Date:

April 2011

Related Keywords:

  • Myelodysplastic Syndrome
  • high risk MDS
  • IPSS
  • 5-AZA-Cytidine
  • Thalidomide
  • response rate
  • cytogenetic response
  • QOL questionaries
  • INT-2 or High risk MDS
  • Myelodysplastic Syndromes
  • Preleukemia

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