Testing a Reduced Conditioning Regimen FB2A2 Preceded by... | NCT02577094

Studies
Testing a Reduced Conditioning Regimen FB2A2 Preceded by a Fractionated Radio-immunotherapy (RIT) With 90Y-Epratuzumab Before Allogeneic Stem Cell Transplantation for Patients With Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia

NCT02577094

Sponsor

Nantes University Hospital

Status

Withdrawn

Last Update Posted

Jun 24, 2026Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia

Interventions

90Y-DOTA-Epratuzumab IgG/Epratuzumab IgG
Busulfan
allogeneic stem cell transplantation.
Fludarabine
Thymoglobulines

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Oct 2, 2015

First Submission Date that Met QC Criteria

Oct 13, 2015

First Posted Date

Oct 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2026

Last Update Posted Date

Jun 24, 2026Actual

Name	Class
Gilead Sciences	INDUSTRY
Institut Cancerologie de l'Ouest	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Determination of the maximum tolerated dose (MTD) of fractionated RIT with epratuzumab radiolabeled with yttrium-90 (90Y-epratuzumab) preceding a reduced conditioning regimen FB2A2 before allogeneic stem cell transplantation.

Detailed Description

Physical examination (screening and follow-up)
Complete blood counts (screening and follow-up)
Dosage of FLT3-ligand in plasma (screening and follow-up)
Blood ionogramme, creatinine hepatic work-up (screening and follow-up)
Left ventricular ejection fraction at pre-implant assessment
Immunization test (screening and follow-up)
Bone marrow aspiration or/and blood CD 22 immunophenotype for minimal residual disease evaluation (screening and follow-up)
All exams which were initially abnormal and which are necessary for response evaluation and All exams which are needed in case of relapse suspicion.
Pharmacokinetic of 90Y-hLL2

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Other Names
90Y-DOTA-Epratuzumab IgG/Epratuzumab IgG	Drug	2 injections of 90Y-DOTA- hLL2 IgG- hLL2 IgG at day -21 and day -14. (The 2 drugs are mixted in the same infusion)	90Y-DOTA- hLL2 IgG and hLL2 IgG
Busulfan	Drug	Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation
allogeneic stem cell transplantation.	Biological	At Day 0
Fludarabine	Drug	Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation
Thymoglobulines	Biological	Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of the maximum tolerated dose (MTD)	Patient toxicity will be evaluated according to NTCAE V4 criteria.	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Overall survival		Month 12
Disease free survival at one year post-transplant		Month 12
Incidence of relapse at 1 year post-transplant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18
Acute lymphoblastic Leukemia (ALL) CD22 + B-type in RC1 with high risk
B-Cell Acute Lymphoblastic Leukemia (ALL) CD22+ beyond RC1.
Expression of CD22 ≥ 30% in tumor population evaluated by flow cytometry or immunohistochemistry at diagnosis stage or relapse stage.
HLA-identical donor intra family or not, without major HLA mismatch (9 / 10th accepted) without contra-indication for stem cell mobilization
ECOG (Eastern Cooperative Oncology Group) ≤ 2
Having or not received previously Epratuzumab
Eligible for an allograft with reduced conditioning regimen
With a signed informed consent
Patient in age of children bearing with adequate contraception
Patient affiliated to or beneficiary of the National Health Service

Exclusion Criteria:

T-cell ALL
Known hypersensibility to 90Y-DOTA-hLL2
Immunization against hLL2 for patients having already received one or several injections of this antibody
Patient eligible for myeloablative conditioning regimen
Other prior malignancies must have had at least a 2-year disease-free interval with the exception of successfully treated carcinoma skin cancer or carcinoma in situ of the cervix.
Patient with progressive psychiatric condition.
HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients who need a treatment
Pregnant or breast-feeding women
Women with childbearing potential without effective contraception
Serious concomitant and uncontrolled infection
Usual contraindications in the allogeneic transplant:
Adult patient protected by the French law

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002066	Busulfan
C024352	fludarabine

ID	Term
D002072	Butylene Glycols
D006018	Glycols
D000438	Alcohols
D009930	Organic Chemicals
D008698	Mesylates
D000476	Alkanesulfonates
D017738	Alkanesulfonic Acids
D000473	Alkanes
D006839	Hydrocarbons, Acyclic
D006838	Hydrocarbons
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds