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Myelodysplastic SyndromesPhase 2NCT00003984

Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome

A Phase 2 study testing lintuzumab in people with Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 9 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
lintuzumab
How many people
0 participants
Where
27 sitesin 9 countries
Study dates
Feb 1999to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS: Histologically confirmed primary myelodysplastic syndrome (MDS) with greater than 10% bone marrow blasts Refractory anemia with excess blasts (RAEB) OR RAEB in transformation No chronic myelomonocytic leukemia No secondary MDS after prior chemotherapy except if treatment was for acute myeloid leukemia No allogeneic bone marrow transplantation planned

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin no greater than 10 g/dL OR transfusion requirement of at least 3 packs of RBCs per month OR Platelet count less than 50,000/mm3 OR Absolute neutrophil count less than 1,000/mm3 No disseminated intravascular coagulation defined as fibrinogen less than 100 mg/dL AND prolonged PT, PTT, or thrombin time AND platelet count less than 25,000/mm3 without transfusion Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 4 times upper limit of normal (ULN) (unless due to underlying disease or Gilbert's syndrome) SGPT and SGOT no greater than 4 times ULN (unless due to underlying disease or Gilbert's syndrome) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No uncontrolled hypertension No congestive heart failure, cardiac arrhythmia, or angina pectoris No history of myocardial infarction within the past 6 months No other significant cardiovascular disease LVEF within normal range by MUGA or echocardiogram No active ischemia Pulmonary: No pulmonary dysfunction Other: No central or peripheral neuropathy No uncontrolled or unstable diabetes No other significant organ system dysfunction HIV negative No prior malignancy except basal cell carcinoma or carcinoma in situ of the uterus No active, uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 2 months since prior biologic therapy (e.g., hematopoietic growth factors or biological response modifiers) Chemotherapy: See Disease Characteristics At least 2 months since prior chemotherapy Endocrine therapy: At least 2 months since prior endocrine therapy Radiotherapy: At least 2 months since prior radiotherapy Concurrent radiotherapy allowed Surgery: At least 2 months since prior surgery Other: No other concurrent investigational drugs

Trial locations and contacts

27 sites in 9 countries.

27 sites in 9 countries

France5 sites
  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Leon Berard

    Lyon, 69373

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Institut Claudius Regaud

    Toulouse, 31052

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Netherlands5 sites
  • Antoni van Leeuwenhoekhuis

    Amsterdam, 1066 CX

  • Academisch Ziekenhuis der Vrije Universiteit

    Amsterdam, 1117 MB

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 EZ

  • University Medical Center Nijmegen

    Nijmegen, NL-6252 HB

  • Rotterdam Cancer Institute

    Rotterdam, 3075 EA

Other trials in Netherlands

Belgium4 sites
  • Institut Jules Bordet

    Brussels, 1000

  • Ludwig Institute for Cancer Research-Brussels Branch

    Brussels, B-1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

United Kingdom4 sites
  • Ninewells Hospital and Medical School

    Dundee, Scotland, DD1 9SY

  • Western General Hospital

    Edinburgh, Scotland, EH4 9NQ

  • C.R.C. Beatson Laboratories

    Glasgow, Scotland, G61 1BD

  • Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

Other trials in United Kingdom

Switzerland3 sites
  • University Hospital

    Basel, CH-4031

  • Inselspital, Bern

    Bern, CH-3010

  • Kantonsspital - Saint Gallen

    Sankt Gallen, CH-9007

Other trials in Switzerland

Austria2 sites
  • Innsbruck Universitaetsklinik

    Innsbruck, A-6020

  • Kaiser Franz Josef Hospital

    Vienna, A-1100

Other trials in Austria

Germany2 sites
  • Universitaetsklinik und Strahlenklinik - Essen

    Essen, D-45122

  • Klinikum Nurnberg

    Nuremberg (Nurnberg), D-90419

Other trials in Germany

Denmark1 site
  • Herlev Hospital - University Hospital of Copenhagen

    Herlev, DK-2730

Other trials in Denmark

Norway1 site
  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
lintuzumab
Keywords
refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
Medical subject headings
Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lintuzumabBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2004 (estimated)
  2. Study startFeb 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003984
Sponsor's protocol ID
EORTC-13981
Other IDs
EORTC-13981
Status last verified
Jul 2012
First submitted
1 Nov 1999
Last updated
11 Jul 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lintuzumab in people with Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France, Netherlands, Belgium, United Kingdom, Switzerland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.

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