Lymphocyte B CD22 Positive Acute Lymphoblastic LeukemiaPhase 1/2EPRALLONCT02577094
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
A Phase 1/2 study testing 90Y-DOTA-Epratuzumab IgG/Epratuzumab IgG, Busulfan and allogeneic stem cell transplantation. in people with Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia, run by Nantes University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia
- What is being tested?
- 90Y-DOTA-Epratuzumab IgG/Epratuzumab IgG, Busulfan and allogeneic stem cell transplantation.
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jan 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
About this study
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.
Read the 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
- Being tested
- 90Y-DOTA-Epratuzumab IgG/Epratuzumab IgG, Busulfan, allogeneic stem cell transplantation., Fludarabine, Thymoglobulines
- Keywords
- CD22 positive- lymphoblastic leukemia-RIT-Yttrium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90Y-DOTA-Epratuzumab IgG/Epratuzumab IgGDrug
Also called 90Y-DOTA- hLL2 IgG and hLL2 IgG
2 injections of 90Y-DOTA- hLL2 IgG- hLL2 IgG at day -21 and day -14. (The 2 drugs are mixted in the same infusion)
BusulfanDrug
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
FludarabineDrug
Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation
ThymoglobulinesBiological
Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the maximum tolerated dose (MTD)
Patient toxicity will be evaluated according to NTCAE V4 criteria.
Measured: 6 weeks
Secondary outcomes (15)
Overall survival
Measured: Month 12
Disease free survival at one year post-transplant
Measured: Month 12
Incidence of relapse at 1 year post-transplant
Measured: Month 12
Non relapse mortality at day 100 post-transplant
Measured: Day 100
Non relapse mortality at one year post-transplant
Measured: Month 12
Hematologic reconstitutions post-transplant
Biological follow-up
Measured: Month 3
Immune reconstitutions post-transplant
Biological follow-up
Measured: Month 3
Incidence of acute and chronic GVHD
Measured: Month 3 and 12
Chimerism post-transplant
Blood sample and/or bone marrow analysis by molecular biology
Measured: Month 3
Residual disease post-transplant
by flow cytometry analysis
Measured: Month 3 and Month 12
Toxicity of RIT
biological follow up and physical examination
Measured: Week 6 and Month 12
Tolerance of RIT
biological follow up and physical examination
Measured: Week 6 and Month 12
Immunization analysis : detection of antibody anti epratuzumab
By ELISA assay
Measured: Month 12
90Y-DOTA-Epratuzumab blood pharmacokinetics
Detection of the radioactivity within the patient's blood samples
Measured: Month 2
Dosage of FLT3-ligand in plasma and correlation with efficacy and toxicity of RIT
by biological assay
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphocyte B CD22 Positive Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Institut Cancerologie de l'Ouest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577094
- Sponsor's protocol ID
- RC14_0429
- Acronym
- EPRALLO
- Status last verified
- Jan 2017
- First submitted
- 2 Oct 2015
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02577094
- Acronym / sponsor ID
- EPRALLO / RC14_0429
- Keywords
- CD22 positive- lymphoblastic leukemia-RIT-Yttrium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences, Institut Cancerologie de l'Ouest
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 90Y-DOTA-Epratuzumab IgG/Epratuzumab IgGAlso: 90Y-DOTA- hLL2 IgG and hLL2 IgG2 injections of 90Y-DOTA- hLL2 IgG- hLL2 IgG at day -21 and day -14. (The 2 drugs are mixted in the same infusion) | Drug | – |
| BusulfanBetween the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation | Drug | – |
| allogeneic stem cell transplantation.At Day 0 | Biological | – |
| FludarabineBetween the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation | Drug | – |
| ThymoglobulinesBetween the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation | Biological | – |
Primary outcome
Determination of the maximum tolerated dose (MTD)
Time frame: 6 weeks
Patient toxicity will be evaluated according to NTCAE V4 criteria.
15 secondary outcomes
Overall survival
Time frame: Month 12
Disease free survival at one year post-transplant
Time frame: Month 12
Incidence of relapse at 1 year post-transplant
Time frame: Month 12
Non relapse mortality at day 100 post-transplant
Time frame: Day 100
Non relapse mortality at one year post-transplant
Time frame: Month 12
Hematologic reconstitutions post-transplant
Time frame: Month 3
Immune reconstitutions post-transplant
Time frame: Month 3
Incidence of acute and chronic GVHD
Time frame: Month 3 and 12
Chimerism post-transplant
Time frame: Month 3
Residual disease post-transplant
Time frame: Month 3 and Month 12
Toxicity of RIT
Time frame: Week 6 and Month 12
Tolerance of RIT
Time frame: Week 6 and Month 12
Immunization analysis : detection of antibody anti epratuzumab
Time frame: Month 12
90Y-DOTA-Epratuzumab blood pharmacokinetics
Time frame: Month 2
Dosage of FLT3-ligand in plasma and correlation with efficacy and toxicity of RIT
Time frame: Month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 90Y-DOTA-Epratuzumab IgG/Epratuzumab IgG, Busulfan and allogeneic stem cell transplantation. in people with Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia, run by Nantes University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the maximum tolerated dose (MTD) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.