Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+

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Brief Title

Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+

Official Title

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

Brief Summary

      The purpose of this study is to determine whether fractionated RIT with Epratuzumab and
      radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Determination of MTD by evaluation of hematological and non hematoligical toxicity

Secondary Outcome

 rate of haematological response

Condition

Acute Lymphoblastic Leukemia

Intervention

Epratuzumab and 90Y-Epratuzumab

Study Arms / Comparison Groups

 Epratuzumab and 90Y-Epratuzumab
Description:  Escalating dose schedule with 5 cohort. For each cohort 3 patients will receive Radio-immunotherapy (RIT ) at Day 1 and Day 8 ± 2 First cohort : 92,5 MBq/m² of 90Y-DOTA-hLL2 associated with hLL2 Second cohort : 185 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2 Third cohort : 277,5 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2 Fourth cohort : 370 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2 Fifth cohort : 462.5 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

21

Start Date

November 2010

Completion Date

June 2016

Primary Completion Date

June 2016

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Chevallier Patrice, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT01354457

Organization ID

BRD 08/12-H


Responsible Party

Sponsor

Study Sponsor

Nantes University Hospital


Study Sponsor

Chevallier Patrice, MD, Principal Investigator, CHU Nantes


Verification Date

May 2011