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A Multicenter, Randomized, Comparative Study of Different Deferasirox Administration Regimens on Gastrointestinal (GI) Tolerability in Low or Intermediate (Int-1) Risk MDS Myelodysplastic Syndrome Patients With Transfusional Iron Overload.


Phase 4
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome,, Transfusional Iron Overload

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Trial Information

A Multicenter, Randomized, Comparative Study of Different Deferasirox Administration Regimens on Gastrointestinal (GI) Tolerability in Low or Intermediate (Int-1) Risk MDS Myelodysplastic Syndrome Patients With Transfusional Iron Overload.


Inclusion Criteria:



- Written informed consent prior to any screening procedures

- Male or female patients ≥ 18 years of age

- Patient must weigh between 45-135 kg

- Patients with low or intermediate (int-1) risk MDS, as determined by IPSS score or
RA, RARS by WHO criteria. IPSS must be confirmed by a bone marrow examination within
6 months prior to study entry and must be hematologically stable

Deferasirox naïve:

Sexually active pre-menopausal female patients must use double-barrier contraception, oral
contraceptive plus barrier contraceptive, or must have undergone clinically documented
total hysterectomy and/or oophorectomy, tubal ligation

Exclusion Criteria:

- History or current GI disease

- Systemic diseases which could prevent study treatments

- Left ventricular ejection fraction< 50 % by echo cardiography

- Serum creatinine > 1.2 x ULN at screening

- Platelet counts < 25x 109/L except in cases where guidance is already given in the
local deferasirox label

- AST or ALT > 2.5 xULN at screening

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

difference in the frequency of overall newly occurring GI adverse events in the two treatment arms

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CICL670A2417

NCT ID:

NCT01326845

Start Date:

December 2011

Completion Date:

September 2012

Related Keywords:

  • Myelodysplastic Syndrome,
  • Transfusional Iron Overload
  • Gastrointestinal adverse events,
  • myelodysplastic syndrome,
  • transfusional iron overload diarrhea,
  • constipation abdominal pain,
  • vomiting
  • Myelodysplastic Syndromes
  • Preleukemia
  • Iron Overload

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