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RIT 90YEpra: Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+

Sponsor
Nantes University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01354457
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
67
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Epratuzumab and 90Y-Epratuzumab
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
21 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Nov 1, 2010
Anticipated Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Epratuzumab and 90Y-Epratuzumab

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

Drug: Epratuzumab and 90Y-Epratuzumab
Sequential injections of each product with an escalating dose for radiolabeled Epratuzumab between patients

Outcome Measures

Primary Outcome Measures

  1. Determination of MTD by evaluation of hematological and non hematoligical toxicity []

    The primary endpoint is to evaluate the incidence of dose limiting toxicities (DLT) in order to determine the maximal tolerated dose (MTD) in a dose escalating study design

Secondary Outcome Measures

  1. rate of haematological response []

    To determine the hematologic response

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Nantes Nantes France 44000

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

  • Principal Investigator: Chevallier Patrice, MD, CHU Nantes
  • Principal Investigator: Kraeber-Bodere Françoise, MD, CHU Nantes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01354457
Other Study ID Numbers:
  • BRD 08/12-H
First Posted:
May 16, 2011
Last Update Posted:
Jun 25, 2014
Last Verified:
May 1, 2011
Keywords provided by Nantes University Hospital
Patient with relapsing or refractory CD22+B-acute lymphoblastic leukemia (ALL)
Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Epratuzumab

Study Results

No Results Posted as of Jun 25, 2014