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1 Year, Open-label Multicenter Evaluation of Efficacy, Safety of Deferasirox in Patients MDS, Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.


Phase 4
2 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome, Thalassemia

Thank you

Trial Information

1 Year, Open-label Multicenter Evaluation of Efficacy, Safety of Deferasirox in Patients MDS, Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.


Inclusion Criteria:



1. Age ≥ 2 years

2. Primary Diagnosis: Myelodysplastic Syndrome (presenting with low or intermediate-1
IPSS risk), thalassemia or rare anemias patients (anemia Diamond-Blackfan, Fanconi's
anemia, Sideroblastic anemia, Red cell aplasia)

3. ECOG Performance Status ≤ 2

4. Transfusion overload confirmed with ferritin level >1000 µg/l.

5. No severe concomitant uncontrolled disease (uncontrolled diabetes mellitus, heart
failure, renal failure).

6. Serum creatine level > ULN

7. No proteinuria

8. Liver enzymes level < 5 ULN.

9. No pregnancy or lactation

10. Signed informed consent by adults. In case inclusion of children under 18 years old,
the informed consent should be signed by parents.

Exclusion Criteria:

1. Age < 2 years

2. No iron overload (Ferritin level <1000 µg/l).

3. Primary iron overload (hereditary hemochromatosis)

4. Severe concomitant disease (uncontrolled diabetes mellitus, heart failure, renal
failure)

5. Elevated serum creatinine > ULN or/and proteinuria

6. Liver enzymes level >5 ULN.

7. Pregnancy or lactation.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

changes in ferritin level, compared to baseline, in patients with transfusion-induced iron overload treated with Exjade

Outcome Time Frame:

Baseline assessment is followed by monthly assessments for up to 1 year

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Russia: Ministry of Health

Study ID:

CICL670ARU01

NCT ID:

NCT01250951

Start Date:

December 2009

Completion Date:

September 2011

Related Keywords:

  • Myelodysplastic Syndrome
  • Thalassemia
  • Iron Overload
  • hemotranfusion
  • deferasirox
  • ferritin
  • Rare anemia
  • Transfusional Iron Overload
  • Anemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Thalassemia
  • Iron Overload

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