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

This study is currently recruiting participants.
Verified May 2011 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01354457
First received: July 17, 2009
Last updated: January 27, 2014
Last verified: May 2011
  Purpose

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 Intervention Phase
Acute Lymphoblastic Leukemia
Drug: Epratuzumab and 90Y-Epratuzumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Determination of MTD by evaluation of hematological and non hematoligical toxicity [ Designated as safety issue: Yes ]
    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:
  • rate of haematological response [ Designated as safety issue: Yes ]
    To determine the hematologic response


Estimated Enrollment: 21
Study Start Date: November 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354457

Contacts
Contact: Chevallier Patrice, MD 0240083994 patrice.chevallier@chu-nantes.fr

Locations
France
CHU Nantes Recruiting
Nantes, France, 44000
Contact: Omnes Anne, MD    0253482835    laetitia.biron@chu-nantes.fr   
Principal Investigator: Chevallier Patrice, MD         
Principal Investigator: Kraeber-Bodere Françoise, MD         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Chevallier Patrice, MD CHU Nantes
Principal Investigator: Kraeber-Bodere Françoise, MD CHU Nantes
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01354457     History of Changes
Other Study ID Numbers: BRD 08/12-H
Study First Received: July 17, 2009
Last Updated: January 27, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Patient with relapsing or refractory CD22+B-acute lymphoblastic leukemia (ALL)

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014