NCT00411905

Brief Summary

We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_1

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 7, 2025

Status Verified

July 1, 2010

Enrollment Period

4.1 years

First QC Date

December 14, 2006

Last Update Submit

January 6, 2025

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic syndromesIPSS Int-2 and High riskBortezomibLow dose CytarabineBone Marrow diseases

Outcome Measures

Primary Outcomes (3)

  • Complete Response

  • Partial Response

  • Efficacy and safety evaluation

    A total of 138 cycles were administered. The median number of cycles administered was 3·2 (range 0·5-8). Thirty-six patients (84%) received at least two cycles and 17 (40%) received the planned four cycles, six responding patients received 1-4 additional cycles. Treatment was dis- continued in the responding patients at progression to AML or for toxicity. The most common treatment-related adverse events were related to myelosuppression . Neutropenia (Grade 4) and thrombocytopenia (Grade 4) were seen during treatment in 51% and 46% of the patients, respectively. Three of the patients with pre-treatment Grade 0-2 neutropenia and thrombocytopenia developed Grade 3-4 toxicity complicated by infection and bleeding. Grade 3-4 neutropenia was responsible for infection in six patients. Grade 3-4

    18 mois

Secondary Outcomes (1)

  • Hematological Improvement

Interventions

BortezomibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MDS with IPSS scores Int-2 or High
  • Life expectancy greater than 6 months
  • No other available treatment options

You may not qualify if:

  • MDS with IPSS scores Low or Int-1
  • \> 30% bone marrow blasts
  • clinical neuropathy of greater than grade 2
  • ECOG Score 3 or 4
  • Creatinine clearance of \< 30 ml/min
  • LMMC
  • Pregnant patients or lactating mothers
  • Patients with uncontrolled pulmonary, cardiac, neurological, gastro-intestinal or genito-urinary disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHU Angers

Angers, 43033, France

Location

Hopital Avicenne

Bobigny, 93009, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CHU de Caen

Caen, 14033, France

Location

CHU Dijon

Dijon, 21000, France

Location

CHU Albert Michallon

Grenoble, 38043, France

Location

CHU de Limoges

Limoges, 87046, France

Location

Hopital Paoli Calmette

Marseille, 13273, France

Location

CHU Archet

Nice, 06202, France

Location

Hopital Cochin

Paris, 75014, France

Location

Centre Hospitalier Joffre

Perpignan, 66046, France

Location

Centre Henry Becquerel

Rouen, 76038, France

Location

Centre Hospitalier Universitaire de STRASBOURG

Strasbourg, 67098, France

Location

CHU Purpan

Toulouse, 31059, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Myelodysplastic SyndromesBone Marrow Diseases

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Francois DREYFUS, MD PhD

    Groupe francaise des Myelodysplasies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Essai ouvert multicentrique de phase I-II
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2006

First Posted

December 15, 2006

Study Start

June 1, 2006

Primary Completion

July 8, 2010

Study Completion

August 1, 2011

Last Updated

January 7, 2025

Record last verified: 2010-07

Locations

FR(15)