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

Conditions

Acute Lymphoblastic Leukemia

Keywords

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

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.

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-Bodéré F.

2015-02-2526 citations

10.1016/s2352-3026(15)00020-4

Phase 1 Dose-Escalation Study of 90yttrium-Labeled Anti-CD22 Epratuzumab Tetraxetan in Adults with Refractory/Relapsed CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Patrice Chevallier, Thomas Eugène, Nelly Robillard, Françoise Isnard, Franck E. Nicolini et al. (21 authors)

Blood2014-12-06

10.1182/blood.v124.21.3708.3708

BCR-ABL1 Molecular Remission After 90y-Epratuzumab Tetraxetan Radioimmunotherapy In CD22+ Ph+ B-ALL: A Potential New Treatment Paradigm

Patrice Chevallier, Caroline Bodet‐Milin, Nelly Robillard, Thomas Eugène, Audrey Ménard et al. (12 authors)

Blood2013-11-151 citations

10.1182/blood.v122.21.3910.3910

Interventions

DRUGEpratuzumab and 90Y-Epratuzumab

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
rate of haematological response	—	To determine the hematologic response

Countries

France

Outcome results

None listed