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Spots Global Cancer Trial Database for Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome

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Trial Identification

Brief Title: Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome

Official Title: Phase II Trial With a Recombinant Humanized Anti-CD33 Monoclonal Antibody (HuM195) in Patients With High Risk Primary Myelodysplastic Syndromes

Study ID: NCT00003984

Interventions

lintuzumab

Study Description

Brief Summary: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have primary myelodysplastic syndrome.

Detailed Description: OBJECTIVES: I. Assess the therapeutic activity of monoclonal antibody HuG1-M195 on peripheral blood and bone marrow blast cell count, blood leukocyte, reticulocyte, and platelet counts, and hemoglobin levels in patients with myelodysplastic syndrome with refractory anemia with excess blasts (RAEB) (greater than 10% bone marrow myeloblasts) or RAEB in transformation. II. Assess the efficacy of this drug in terms of duration of response in these patients. III. Evaluate the toxicity of this drug in these patients. OUTLINE: Patients receive monoclonal antibody HuG1-M195 IV over 4 hours on days 1-4. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with progressive disease after 2 courses are removed from study. Patients with stable disease receive no further treatment after 4 courses. Patients with complete or partial response receive treatment for 4 additional courses. Patients are followed at 11 and 39 days after end of course 4, monthly for 4 months, then every 3 months thereafter for 1 year from study entry. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Innsbruck Universitaetsklinik, Innsbruck, , Austria

Kaiser Franz Josef Hospital, Vienna, , Austria

Institut Jules Bordet, Brussels, , Belgium

Ludwig Institute for Cancer Research-Brussels Branch, Brussels, , Belgium

Universitair Ziekenhuis Antwerpen, Edegem, , Belgium

U.Z. Gasthuisberg, Leuven, , Belgium

Herlev Hospital - University Hospital of Copenhagen, Herlev, , Denmark

Centre Jean Perrin, Clermont-Ferrand, , France

Centre Leon Berard, Lyon, , France

CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France

Institut Claudius Regaud, Toulouse, , France

Institut Gustave Roussy, Villejuif, , France

Universitaetsklinik und Strahlenklinik - Essen, Essen, , Germany

Klinikum Nurnberg, Nuremberg (Nurnberg), , Germany

Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands

Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, , Netherlands

Academisch Ziekenhuis Groningen, Groningen, , Netherlands

University Medical Center Nijmegen, Nijmegen, , Netherlands

Rotterdam Cancer Institute, Rotterdam, , Netherlands

Norwegian Radium Hospital, Oslo, , Norway

University Hospital, Basel, , Switzerland

Inselspital, Bern, Bern, , Switzerland

Kantonsspital - Saint Gallen, Saint Gallen, , Switzerland

Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom

Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom

Western General Hospital, Edinburgh, Scotland, United Kingdom

C.R.C. Beatson Laboratories, Glasgow, Scotland, United Kingdom

Contact Details

Name: Heinz Zwierzina, MD

Affiliation: Medical University Innsbruck

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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