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Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adult Patients With Low- and Int-1-risk Myelodysplastic Syndrome.

Intervention: Erythropoietin alpha (Drug); Erythropoietin alpha (Drug); Deferasirox (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: 1-888-669-6682

Summary

The primary purpose of this trial 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 myelodysplastic syndrome. The addition of deferasirox to erythropoietin could lead to a potential synergism with the reduction of reactive oxygen species, through both the NF-kB pathway and the control of free toxic iron. This may create a better environment in the bone marrow for a better response with erythropoietin. This study is designed to test in a prospective way the combination of deferasirox with erythropoietin in term of their effect on hematopoiesis.

Clinical Details

Official title: 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.

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

Primary outcome: Change in hemoglobin levels

Secondary outcome:

Change in hemoglobin, platelets and neutrophil levels

Change in hemoglobin levels

Time to erythroid response

Time to hematologic response

Duration of erythroid response

Number of adverse events (AEs) and serious adverse events (SAEs)

Iron parameters by change in serum ferritin

Change in platelets and neutrophil levels

Time to hematologic improvement

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

- Documented diagnosis of the following:

Myelodysplastic syndrome lasting ≥ 3 months and < 3 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 ≥ 8 g/dL

- History of transfusions < 10 RBC units and must not be RBC transfusion dependent

- 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 (stable steroid treatment for adrenal failure or chronic medical conditions, and intermittent dexamethasone as antiemetics are allowed).

- B12 and folate deficient patients with and without clinical symptoms (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.

Locations and Contacts

Novartis Pharmaceuticals, Phone: 1-888-669-6682

Novartis Investigative Site, Oran 31000, Algeria; Not yet recruiting

Novartis Investigative Site, Sidi Bel abbes 22000, Algeria; Not yet recruiting

Novartis Investigative Site, Sofia 1756, Bulgaria; Withdrawn

Novartis Investigative Site, Varna 9000, Bulgaria; Withdrawn

Novartis Investigative Site, Jinan 250012, China; Not yet recruiting

Novartis Investigative Site, Berlin 12203, Germany; Recruiting

Novartis Investigative Site, Dresden 01307, Germany; Not yet recruiting

Novartis Investigative Site, Duesseldorf 40225, Germany; Recruiting

Novartis Investigative Site, Rostock 18107, Germany; Recruiting

Novartis Investigative Site, Madrid 28006, Spain; Withdrawn

Novartis Investigative Site, Madrid 28033, Spain; Withdrawn

Novartis Investigative Site, Gothenburg 413 45, Sweden; Recruiting

Novartis Investigative Site, Linköping SE-581 85, Sweden; Recruiting

Novartis Investigative Site, Luleå SE-971 80, Sweden; Recruiting

Novartis Investigative Site, Stockholm SE-118 83, Sweden; Withdrawn

Novartis Investigative Site, Stockholm SE-141 86, Sweden; Recruiting

Novartis Investigative Site, Sundsvall 851 86, Sweden; Recruiting

Novartis Investigative Site, London WC1E 6HX, United Kingdom; Recruiting

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas 72703, United States; Withdrawn

Hematology Oncology Services of Arkansas SC, Little Rock, Arkansas 72205, United States; Withdrawn

Novartis Investigative Site, Beijing, Beijing 100730, China; Not yet recruiting

Novartis Investigative Site, Vancouver, British Columbia V6Z1Y6, Canada; Recruiting

Novartis Investigative Site, Caba, Buenos Aires C1221ADC, Argentina; Withdrawn

Novartis Investigative Site, La Plata, Buenos Aires B1900AWT, Argentina; Recruiting

Novartis Investigative Site, Cagliari, CA 09100, Italy; Recruiting

Pacific Cancer Medical Center, Inc., Anaheim, California 92801, United States; Completed

Novartis Investigative Site, Cambridge, Cambrigdeshire CB2 0QQ, United Kingdom; Withdrawn

Novartis Investigative Site, Badalona, Catalunya 08916, Spain; Recruiting

Novartis Investigative Site, Girona, Catalunya 17007, Spain; Recruiting

Novartis Investigative Site, Hospitalet de LLobregat, Catalunya 08907, Spain; Recruiting

Novartis Investigative Site, Firenze, FI 50134, Italy; Recruiting

21st Century Oncology SC, Orange Park, Florida 32073, United States; Withdrawn

University of Hawaii Cancer Center SC ICL670A2421, Honolulu, Hawaii 96813, United States; Withdrawn

Novartis Investigative Site, Wuhan, Hubei 430030, China; Not yet recruiting

Rush University Medical Center Rush University, Chicago, Illinois 60612, United States; Withdrawn

Novartis Investigative Site, Nanjing, Jiangsu, China; Not yet recruiting

Novartis Investigative Site, Suzhou, Jiangsu 215006, China; Not yet recruiting

Novartis Investigative Site, Seoul, Korea 135-710, Korea, Republic of; Recruiting

Novartis Investigative Site, Seoul, Korea 138-736, Korea, Republic of; Recruiting

Novartis Investigative Site, Oldham, Lancashire OL1 2JH, United Kingdom; Active, not recruiting

Meridian Health Research Services SC, Neptune, New Jersey 07753, United States; Not yet recruiting
Nancy Lynn Charpek, Email: NCharpek@meridianhealth.com
Aileen Chen, Principal Investigator

Montefiore Medical Center SC ICL670A2421, Bronx, New York 10467-2490, United States; Recruiting
Rana Abdelhamid, Phone: 718-920-6642, Email: raabdelh@montefiore.org
Olga Derman, Principal Investigator

Rochester General Hospital / Lipson Cancer Center SC, Rochester, New York 14621, United States; Recruiting
Brittany Heatherington, Phone: 585-922-4040, Email: Brittany.Heatherington@rochesterregional.org
Pradyumna Phatak, Principal Investigator

Novartis Investigative Site, Hamilton, Ontario L8V 5C2, Canada; Recruiting

Novartis Investigative Site, Toronto, Ontario M4N 3M5, Canada; Recruiting

Novartis Investigative Site, Reggio Calabria, RC 89124, Italy; Recruiting

Novartis Investigative Site, Roma, RM 00161, Italy; Recruiting

St. Francis Hospital, Greenville, South Carolina 29601, United States; Withdrawn

Novartis Investigative Site, Baracaldo, Vizcaya 48903, Spain; Withdrawn

Novartis Investigative Site, Hangzhou, Zhejiang 310003, China; Not yet recruiting

Additional Information

Starting date: January 2014
Last updated: July 12, 2015

Page last updated: August 23, 2015

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