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

Acute Lymphoblastic Leukemia Clinical Trial

— RIT 90YEpra  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01354457
• Other study ID #: BRD 08/12-H
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: July 17, 2009
• Last updated: June 24, 2014
• Start date: November 2010
• Est. completion date: June 2016

Study information

• Verified date: May 2011
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Yes
Secondary	rate of haematological response	To determine the hematologic response		Yes