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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01354457 |
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Date of registration:
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17/07/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+
RIT 90YEpra |
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Scientific title:
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Evaluation of the Efficacy and Tolerance of Fractionated Radio-immunotherapy With 90Y-Epratuzumab (90Y-hLL2) for Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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21 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01354457 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Chevallier Patrice, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Nantes |
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Name:
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Kraeber-Bodere Françoise, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Nantes |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18-70 years
- B-ALL (OMS) with >=20% of blasts in bone marrow
- CD22+ expression >=70% of the blast population
- All previously treated ALL patients who have experienced relapse or treatment failure
- At least 15 days since previous treatment
- Performance status 0 - 2
- Creatinine clearance >= 50 ml/min (Cockroft formula).
- Serum bilirubin <= 30 mmol/l
- Written informed consent
Exclusion Criteria:
- T-ALL
- Meningeal involvement
- CD22 expression on tumor cells or < 70%
- HIV positive
- Active Hepatitis B or C
- Active infection within 7 days of starting treatment
- Left ventricular ejection fraction < 50%.
- Contra-indication to 90Y-DOTA-hLL2
- Previous or concurrent second malignancy except for adequately treated basal cell
carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively
treated solid cancer, with no evidence of disease for at least 5 years
- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule
- Participation at the same time in another study in which investigational drugs are
used
- Absence of written informed consent
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Lymphoblastic Leukemia
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Intervention(s)
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Drug: Epratuzumab and 90Y-Epratuzumab
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Primary Outcome(s)
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Determination of MTD by evaluation of hematological and non hematoligical toxicity
[Time Frame: Yes]
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Secondary Outcome(s)
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rate of haematological response
[Time Frame: Yes]
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Secondary ID(s)
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BRD 08/12-H
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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