Back to resultsSafety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+ (RIT 90YEpra)
Primary Purpose
Acute Lymphoblastic Leukemia
Status
Unknown status
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Epratuzumab and 90Y-Epratuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Patient with relapsing or refractory CD22+B-acute lymphoblastic leukemia (ALL)
Eligibility 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
Sites / Locations
- CHU Nantes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epratuzumab and 90Y-Epratuzumab
Arm Description
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
Outcomes
Primary Outcome Measures
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
rate of haematological response
To determine the hematologic response
Full Information
NCT ID
NCT01354457
First Posted
July 17, 2009
Last Updated
June 24, 2014
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01354457
Brief Title
Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Patient with relapsing or refractory CD22+B-acute lymphoblastic leukemia (ALL)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epratuzumab and 90Y-Epratuzumab
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Epratuzumab and 90Y-Epratuzumab
Intervention Description
Sequential injections of each product with an escalating dose for radiolabeled Epratuzumab between patients
Primary Outcome Measure Information:
Title
Determination of MTD by evaluation of hematological and non hematoligical toxicity
Description
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 Measure Information:
Title
rate of haematological response
Description
To determine the hematologic response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chevallier Patrice, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kraeber-Bodere Françoise, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26687796
Citation
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.
Results Reference
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Learn more about this trial
Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+
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