NCT01354457

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 25, 2014

Status Verified

May 1, 2011

Enrollment Period

5.6 years

First QC Date

July 17, 2009

Last Update Submit

June 24, 2014

Conditions

Acute Lymphoblastic Leukemia

Keywords

Patient with relapsing or refractory CD22+B-acute lymphoblastic leukemia (ALL)

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • rate of haematological response

Study Arms (1)

Epratuzumab and 90Y-Epratuzumab

EXPERIMENTAL

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

Interventions

Epratuzumab and 90Y-EpratuzumabDRUG

Sequential injections of each product with an escalating dose for radiolabeled Epratuzumab between patients

Epratuzumab and 90Y-Epratuzumab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nantes

Nantes, 44000, France

Location

Related Publications (1)

  • Chevallier P, Eugene T, Robillard N, Isnard F, Nicolini F, Escoffre-Barbe M, Huguet F, Hunault M, Marcais A, Gaschet J, Cherel M, Guillaume T, Delaunay J, Peterlin P, Eveillard M, Thomas X, Ifrah N, Lapusan S, Bodet-Milin C, Barbet J, Faivre-Chauvet A, Ferrer L, Bene MC, Le Houerou C, Goldenberg DM, Wegener WA, Kraeber-Bodere F. (90)Y-labelled anti-CD22 epratuzumab tetraxetan in adults with refractory or relapsed CD22-positive B-cell acute lymphoblastic leukaemia: a phase 1 dose-escalation study. Lancet Haematol. 2015 Mar;2(3):e108-17. doi: 10.1016/S2352-3026(15)00020-4. Epub 2015 Feb 25.

    PMID: 26687796DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

epratuzumab

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Chevallier Patrice, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

  • Kraeber-Bodere Françoise, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2009

First Posted

May 16, 2011

Study Start

November 1, 2010

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 25, 2014

Record last verified: 2011-05

Locations

FR(1)