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An Open-label, Phase II, Randomized, Pilot Study to Assess the Effect in Term of Erythroid Improvement of Deferasirox Combined With Erythropoietin Compared to Erythropoietin Alone in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.


Phase 2
18 Years
N/A
Not Enrolling
Both
Adult Patients With Low- and Int-1-risk Myelodysplastic Syndrome.

Thank you

Trial Information

An Open-label, Phase II, Randomized, Pilot Study to Assess the Effect in Term of Erythroid Improvement of Deferasirox Combined With Erythropoietin Compared to Erythropoietin Alone in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.


Inclusion Criteria:



- Patients with low- and Int-1-risk myelodysplastic syndrome

- Documented diagnosis of the following:

Myelodysplastic syndrome lasting ≥ 3 months and < 2 years Disease must not be secondary to
treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or
autoimmune diseases

- A hemoglobin < 10 g/dL and > 6 g/dL (no RBC transfusions are allowed during study)

- History of transfusions < 10 RBC units

- 300 ng/mL < serum ferritin < 1,000 ng/mL

- Endogenous erythropoietin levels < 500 units/L

Exclusion Criteria:

- Patients with MDS with isolated del(5q)

- Patients who had received prior EPO treatment or other recombinant growth factors
regardless of the outcome (Patient who had received prior EPO treatment or other
recombinant growth factors for less than 4 weeks and not within 3 months before
screening without a documented response are allowed)

- Patients receiving steroids or immunosuppressive therapy for the improvement of
hematological parameters (prophylactic hydrocortisone to prevent transfusion
reaction, steroid for adrenal failure, and intermittent dexamethasone as antiemetic
are allowed).

- B12 and folate deficient patients (patients could be rescreened after successful
therapy of B12 and folate deficiency)

- Uncontrolled seizures or uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in hemoglobin levels

Outcome Description:

Difference in proportion of patients achieving an erythroid response within 12 weeks of treatment between the two arms according to modified IWG 2006 criteria (increase in Hb ≥ 1.5 g/dL)

Outcome Time Frame:

Within 12 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CICL670A2421

NCT ID:

NCT01868477

Start Date:

August 2013

Completion Date:

February 2015

Related Keywords:

  • Adult Patients With Low- and Int-1-risk Myelodysplastic Syndrome.
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Bon Secours St. Francis HospitalGreenville, South Carolina  29601
Rush University Medical Center Rush UniversityChicago, Illinois  60612