Trial record 8 of 1767 for:    "Acute lymphoblastic leukemia"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01354457
Recruitment Status : Unknown
Verified May 2011 by Nantes University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2011
Last Update Posted : June 25, 2014
Information provided by (Responsible Party):
Nantes University Hospital

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

Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2010
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

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

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01354457

CHU Nantes
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: Chevallier Patrice, MD CHU Nantes
Principal Investigator: Kraeber-Bodere Françoise, MD CHU Nantes

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nantes University Hospital Identifier: NCT01354457     History of Changes
Other Study ID Numbers: BRD 08/12-H
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: May 2011

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

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