Status:
COMPLETED
Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Low and Int 1-risk Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose of this trial was is to assess the effect of treatment with deferasirox combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low- and int-1-risk...
Detailed Description
This study did not meet the original enrollment objective of 60 patients and was terminated without extending enrollment past original planned LPFV of 31-Oct-2016.
Eligibility Criteria
Inclusion
- Key
- Patients who had low- and Int-1-risk myelodysplastic syndrome
- Documented diagnosis of the following:
- Myelodysplastic syndrome that lasted ≥ 3 months and \< 3 years Disease must not have been secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases
- A hemoglobin \< 10 g/dL and ≥ 8 g/dL
- History of transfusions \< 10 RBC units and must not have been RBC transfusion dependent
- 300 ng/mL \< serum ferritin \< 1,500 ng/mL (Values within 10% difference above 1500 ng/ml or 10% difference below 300 ng/ml could have been accepted at the investigator's discretion.
- Endogenous erythropoietin levels \< 500 units/L
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Creatinine clearance above the concentration limit in locally approved prescribing information (PI). Patients with creatinine clearance between 40 and less than 60 mL/min, who did not present with additional risk factors that might impair renal function, were eligible at the discretion of the investigator
- Key
Exclusion
- Patients who had 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 who had received steroids or immunosuppressive therapy for the improvement of hematological parameters (stable steroid treatment for adrenal failure or chronic medical conditions, and intermittent dexamethasone as antiemetics were allowed).
- B12 and folate deficient patients with and without clinical symptoms (patients were rescreened after successful therapy of B12 and folate deficiency)
- Uncontrolled seizures or uncontrolled hypertension
Key Trial Info
Start Date :
January 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01868477
Start Date
January 28 2014
End Date
April 5 2017
Last Update
October 31 2018
Active Locations (30)
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1
Novartis Investigative Site
Oran, Algeria, 31000
2
Novartis Investigative Site
Sidi Bel Abbes, Algeria, 22000
3
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1425DND
4
Novartis Investigative Site
La Plata, Buenos Aires, Argentina, B1900AWT