CD22+ Relapsed/Refractory B-ALLPhase 2RITEPRALLNCT02844530
Study Evaluating the Efficacy of 90Yttrium-epratuzumab in Adults With CD22+ Relapsed/Refractory B-ALL
A Phase 2 study testing 90Y-epratuzumab tetraxetan and chemotherapy/ immunotherapy in people with CD22+ Relapsed/Refractory B-ALL, run by Nantes University Hospital at 1 site in France.
Trial summary
The investigators propose a randomized phase 2 study evaluating 90Y-epratuzumab tetraxetan for relapsed/refractory CD22+ B-ALL adult patients using the recommended activity of 370 MBq/m² x 2. in order to confirm the investigators' previous results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD22+ Relapsed/Refractory B-ALL
- What is being tested?
- 90Y-epratuzumab tetraxetan and chemotherapy/ immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Jan 2017
- Phase
- Phase 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 years old
- Philadelphia positive or negative B-ALL (OMS) with >5% of blasts in bone marrow with or without extramedullary disease
- CD22+ expression >=30% of the blast population
- Refractory B-ALL defined by :
- treatment failure after 1 or 2 successive courses of induction therapy or first relapse <6 months from CR.
- First relapse, second or third relapse.
Show all 33Show fewer
- Unresponsive to prior treatment with >=1 second/third (dasatinib, nilotinib, bosutinib, ponatinib) generation TKIs and standard induction chemotherapy for Ph+ B-ALL patients only.
- Peripheral absolute lymphoblast count <10000/µL: hydroxyurea and/or steroids/vincristine treatment within 2 weeks of randomization is allowed to reduce circulating blasts.
- ECOG (Eastern Cooperative Oncology Group) < 2
- Creatinine clearance >= 50 ml/min (Cockroft formula) or serum creatinine <=1.5 x ULN
- Adequate hepatic function: total serum bilirubin < 1.5 x upper limit of normal (ULN) except for documented Gilbert syndrome or considered tumor related; <=5 ULN for transaminases except if considered tumor related
- Written informed consent
- Having or not received previously Epratuzumab: in case of having received previously epratuzumab, patients should be free of HAHA (anti-epratuzumab antibodies).
- Patient affiliated to or beneficiary of the National Health Service
- Patients with lymphoblastic lymphoma can be included if they satisfied all eligibility criteria.
- Non-inclusion criteria:
- T-ALL, patients with Burkitt lymphoma
- Active Meningeal involvement
- Isolated extramedullary relapse
- CD22 expression on tumor cells or < 30%
- HIV positive
- Active Hepatitis B or C
- Allogeneic transplantation within 12 weeks prior to the start of chemo/immunotherapy or RIT
- Active acute or chronic GVHD, systemic treatment of GVHD within two weeks before the treatment start.
- No chemotherapy/immunotherapy <2 weeks before randomization except to reduce the circulating lymphoblast count.
- Left ventricular ejection fraction < 45%
- Contra-indication to 90Y-epratuzumab tetraxetan
- 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 2 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
- Pregnant or breastfeeding women
- Women or men without effective contraceptive barrier if needed
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Study Evaluating the Efficacy of 90Yttrium-epratuzumab Tetraxetan Radioimmunotherapy in Adults With CD22+ Relapsed/Refractory B-ALL
The investigators propose a randomized phase 2 study evaluating 90Y-epratuzumab tetraxetan for relapsed/refractory CD22+ B-ALL adult patients using the recommended activity of 370 MBq/m² x 2. in order to confirm the investigators' previous results. The cut-off of 70% for the expression of CD22 has been chosen in order to propose this protocol to all adults with CD22+ B ALL in relapse or with refractory disease. Indeed, median expression of CD22 is almost 100% in this setting but some patients are documented between 70 and 100%. RIT will be assessed in comparison with standard of care salvage chemotherapy regimens. Only three standard salvage chemotherapy regimens will be permitted in order to avoid too much bias for the comparative analysis of clinical efficacy.
Read the detailed description
The experimental treatment will consist on 2 injections of 370 MBq/m2 of 90Y-epratuzumab tetraxetan fractionated RIT at day 1 and day 8. The first infusion of 90Y-epratuzumab tetraxetan will be co-injected for the six first patients in Nantes with 111In-epratuzumab tetraxetan for dosimetry purpose.
Subjects randomized to receive standard of care salvage chemotherapy/ immunotherapy regimen will be assigned per investigator's choice to one of the following chemotherapy/ immunotherapy regimens:
- FLAG +- anthracycline based regimen (such as Idarubicin 10 mg/m2 days 1, 3; fludarabine 30 mg/m2 days 1-5, cytarabine 2 g/m2 days 1-5). For subject's >60 years : idarubicin 5 mg/m2 day 1,3, fludarabine 20 mg/m2 days 1-5, cytarabine 1 g/m2 days 1-5.
- Clofarabine or clofarabine based regimens. Clofarabine use as a single agent should follow the recommended prescribing information. Clofarabine combination based regimens should use >=20mg/m2/day for up to 5 days.
- Hyper-C-VAd regimen: hyperfractionated cyclophosphamide 300 mg/m2 intravenously(i.v.) every 12 hours for 6 doses Days 1 to 3 + vincristine 2 mg i.v.Days 4 and 11; doxorubicin 50 mg/m2 i.v. over 24 hours via central venous catheter Day 4; and dexa-methasone 40 mg daily Days 1 to 4 and 11 to 14.
- Blinatumomab (Blincyto®) is administered as a 28-day continuous infusion (9µg/d for days 1-7; 28µg/d thereafter, followed by 2 weeks of rest for up to 2 cycles. Patients should be hospitalized the first 9 days during the first cycle and at least the first 2 days during the second cycle.
A second RIT cycle (consolidation) will be allowed in the experimental group in case of response (CR or CRp).
From an ethical point of view, it will be also permitted to propose the RIT experimental treatment in the control group in case of treatment failure or relapse during the 6 months following inclusion. Follow-up will be also 12 months from the RIT for these patients.
- Conditions
- CD22+ Relapsed/Refractory B-ALL
- Being tested
- 90Y-epratuzumab tetraxetan, chemotherapy/ immunotherapy
- Keywords
- adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90Y-epratuzumab tetraxetanDrug
Also called 90Y-DOTA-hLL2 or 90Y-DOTA-Epratuzumab
The Primary objective is to compare the complete response rate (CR + CRp) after 2 injections of 370 MBq/m² of 90Y-epratuzumab tetraxetan RIT at day 1 and day 8 versus standard of care salvage chemotherapy regimens in adult CD22+ relapsed/refractory B-ALL.
A second RIT cycle (consolidation) will be allowed in the experimental group in case of response (CR or CRp).
From an ethical point of view, it will be also permitted to propose the RIT experimental treatment in the control group in case of treatment failure or relapse during the 6 months following inclusion. Follow-up will be also 12 months from the RIT for these patients
chemotherapy/ immunotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| RIT | Experimental | The experimental treatment will consist on 2 injections of 370 MBq/m2 of 90Y-epratuzumab tetraxetan fractionated RIT at day 1 and day 8. The first infusion of 90Y-epratuzumab tetraxetan will be co-injected for the six first patients in Nantes with 111In-epratuzumab tetraxetan for dosimetry purpose. Receives: Drug: 90Y-epratuzumab tetraxetan |
| chemotherapy/ immunotherapy | Active comparator | chemotherapy/ immunotherapy regimen will be assigned per investigator's choice to one of the following chemotherapy/ immunotherapy regimens:
1. FLAG +- anthracycline based regimen For subject's >60 years : idarubicin 5 mg/m2 day 1,3, fludarabine 20 mg/m2 days 1-5, cytarabine 1 g/m2 days 1-5.
2. Clofarabine or clofarabine based regimens. Clofarabine use as a single agent should follow the recommended prescribing information. Clofarabine combination based regimens should use >=20mg/m2/day for up to 5 days.
3. Hyper-C-VAd regimen: hyperfractionated cyclophosphamide 300 mg/m2 intravenously(i.v.) every 12 hours for 6 doses Days 1 to 3 + vincristine 2 mg i.v.Days 4 and 11; doxorubicin 50 mg/m2 i.v. over 24 hours via central venous catheter Day 4; and dexa-methasone 40 mg daily Days 1 to 4 and 11 to 14.
4. Blinatumomab (Blincyto®) : 28-day continuous infusion (9µg/d for days 1-7; 28µg/d thereafter, followed by 2 weeks of rest for up to 2 cycles. Receives: Drug: chemotherapy/ immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the complete response rate (CR + CRp) in the two arms
Evaluated between 4 and 6 weeks from day 1. Blood and bone marrow analysis.
Measured: Week 4 to Week 6
Secondary outcomes (15)
Overall survival: overall and comparison between both groups
clinical follow up
Measured: Month 1 to Month 12
Disease free survival
clinical follow up
Measured: Month 1 to Month 12
time to disease progression
clinical follow up
Measured: Month 1 to Month 12
duration of response
clinical follow up
Measured: Month 1 to Month 12
CD22 expression
bone marrow analysis
Measured: Month 1 to Month 12
CD22 expression
blood
Measured: Month 1 to Month 12
Safety and tolerance of fractionated RIT with 90Y-epratuzumab tetraxetan assessed by NCI Criteria
NCI Criteria
Measured: Month 1 to Month 12
Immunization test to search for antibodies by ELISA test
Blood assay (ELISA method)
Measured: Month 1 to Month 6
Realization of a blood pharmacokinetics profile of 111In /90Y-epratuzumab tetraxetan
Blood counting
Measured: 1 week after 90Y-epratuzumab tetraxetan injection
Tumour and organ dosimetry of 90Y-epratuzumab tetraxetan assessed using 111In-epratuzumab tetraxetan biodistribution
dosimetry analysis
Measured: 1 week after 90Y-epratuzumab tetraxetan injection
Correlation between FLT3-ligand serum value and efficacy and toxicity after treatment
Blood analysis
Measured: Month 1 to Month 12
Relapse incidence: overall and comparison between both groups
blood
Measured: Month 1 to Month 12
Relapse incidence: overall and comparison between both groups
bone marrow analysis
Measured: Month 1 to Month 12
Minimal Residual Disease (MRD) (by FACS analysis)
blood
Measured: Month 1 to Month 12
Minimal Residual Disease (MRD) (by FACS analysis)
bone marrow analysis
Measured: Month 1 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (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 CD22+ Relapsed/Refractory B-ALLStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844530
- Sponsor's protocol ID
- RC15_0088
- Acronym
- RITEPRALL
- Status last verified
- Jan 2017
- First submitted
- 13 Nov 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study Evaluating the Efficacy of 90Yttrium-epratuzumab Tetraxetan Radioimmunotherapy in Adults With CD22+ Relapsed/Refractory B-ALL
- ClinicalTrials.gov ID
- NCT02844530
- Acronym / sponsor ID
- RITEPRALL / RC15_0088
- Conditions
- CD22+ Relapsed/Refractory B-ALL
- Keywords
- adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Jul 2016 (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.
The investigators propose a randomized phase 2 study evaluating 90Y-epratuzumab tetraxetan for relapsed/refractory CD22+ B-ALL adult patients using the recommended activity of 370 MBq/m² x 2. in order to confirm the investigators' previous results. The cut-off of 70% for the expression of CD22 has been chosen in order to propose this protocol to all adults with CD22+ B ALL in relapse or with refractory disease. Indeed, median expression of CD22 is almost 100% in this setting but some patients are documented between 70 and 100%. RIT will be assessed in comparison with standard of care salvage chemotherapy regimens. Only three standard salvage chemotherapy regimens will be permitted in order to avoid too much bias for the comparative analysis of clinical efficacy.
Detailed description
The experimental treatment will consist on 2 injections of 370 MBq/m2 of 90Y-epratuzumab tetraxetan fractionated RIT at day 1 and day 8. The first infusion of 90Y-epratuzumab tetraxetan will be co-injected for the six first patients in Nantes with 111In-epratuzumab tetraxetan for dosimetry purpose.
Subjects randomized to receive standard of care salvage chemotherapy/ immunotherapy regimen will be assigned per investigator's choice to one of the following chemotherapy/ immunotherapy regimens:
- FLAG +- anthracycline based regimen (such as Idarubicin 10 mg/m2 days 1, 3; fludarabine 30 mg/m2 days 1-5, cytarabine 2 g/m2 days 1-5). For subject's >60 years : idarubicin 5 mg/m2 day 1,3, fludarabine 20 mg/m2 days 1-5, cytarabine 1 g/m2 days 1-5.
- Clofarabine or clofarabine based regimens. Clofarabine use as a single agent should follow the recommended prescribing information. Clofarabine combination based regimens should use >=20mg/m2/day for up to 5 days.
- Hyper-C-VAd regimen: hyperfractionated cyclophosphamide 300 mg/m2 intravenously(i.v.) every 12 hours for 6 doses Days 1 to 3 + vincristine 2 mg i.v.Days 4 and 11; doxorubicin 50 mg/m2 i.v. over 24 hours via central venous catheter Day 4; and dexa-methasone 40 mg daily Days 1 to 4 and 11 to 14.
- Blinatumomab (Blincyto®) is administered as a 28-day continuous infusion (9µg/d for days 1-7; 28µg/d thereafter, followed by 2 weeks of rest for up to 2 cycles. Patients should be hospitalized the first 9 days during the first cycle and at least the first 2 days during the second cycle.
A second RIT cycle (consolidation) will be allowed in the experimental group in case of response (CR or CRp).
From an ethical point of view, it will be also permitted to propose the RIT experimental treatment in the control group in case of treatment failure or relapse during the 6 months following inclusion. Follow-up will be also 12 months from the RIT for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIT | Experimental | Drug: 90Y-epratuzumab tetraxetanThe experimental treatment will consist on 2 injections of 370 MBq/m2 of 90Y-epratuzumab tetraxetan fractionated RIT at day 1 and day 8. The first infusion of 90Y-epratuzumab tetraxetan will be co-injected for the six first patients in Nantes with 111In-epratuzumab tetraxetan for dosimetry purpose. |
| chemotherapy/ immunotherapy | Active comparator | Drug: chemotherapy/ immunotherapychemotherapy/ immunotherapy regimen will be assigned per investigator's choice to one of the following chemotherapy/ immunotherapy regimens: 1. FLAG +- anthracycline based regimen For subject's >60 years : idarubicin 5 mg/m2 day 1,3, fludarabine 20 mg/m2 days 1-5, cytarabine 1 g/m2 days 1-5. 2. Clofarabine or clofarabine based regimens. Clofarabine use as a single agent should follow the recommended prescribing information. Clofarabine combination based regimens should use >=20mg/m2/day for up to 5 days. 3. Hyper-C-VAd regimen: hyperfractionated cyclophosphamide 300 mg/m2 intravenously(i.v.) every 12 hours for 6 doses Days 1 to 3 + vincristine 2 mg i.v.Days 4 and 11; doxorubicin 50 mg/m2 i.v. over 24 hours via central venous catheter Day 4; and dexa-methasone 40 mg daily Days 1 to 4 and 11 to 14. 4. Blinatumomab (Blincyto®) : 28-day continuous infusion (9µg/d for days 1-7; 28µg/d thereafter, followed by 2 weeks of rest for up to 2 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Age>= 18 years old
- Philadelphia positive or negative B-ALL (OMS) with >5% of blasts in bone marrow with or without extramedullary disease
- CD22+ expression >=30% of the blast population
- Refractory B-ALL defined by :
- Peripheral absolute lymphoblast count <10000/µL: hydroxyurea and/or steroids/vincristine treatment within 2 weeks of randomization is allowed to reduce circulating blasts.
Key exclusion criteria (0 listed)
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-epratuzumab tetraxetanAlso: 90Y-DOTA-hLL2 or 90Y-DOTA-EpratuzumabThe Primary objective is to compare the complete response rate (CR + CRp) after 2 injections of 370 MBq/m² of 90Y-epratuzumab tetraxetan RIT at day 1 and day 8 versus standard of care salvage chemotherapy regimens in adult CD22+ relapsed/refractory B-ALL. A second RIT cycle (consolidation) will be allowed in the experimental group in case of response (CR or CRp). From an ethical point of view, it will be also permitted to propose the RIT experimental treatment in the control group in case of treatment failure or relapse during the 6 months following inclusion. Follow-up will be also 12 months from the RIT for these patients | Drug | RIT |
| chemotherapy/ immunotherapy | Drug | chemotherapy/ immunotherapy |
Primary outcome
Compare the complete response rate (CR + CRp) in the two arms
Time frame: Week 4 to Week 6
Evaluated between 4 and 6 weeks from day 1. Blood and bone marrow analysis.
15 secondary outcomes
Overall survival: overall and comparison between both groups
Time frame: Month 1 to Month 12
Disease free survival
Time frame: Month 1 to Month 12
time to disease progression
Time frame: Month 1 to Month 12
duration of response
Time frame: Month 1 to Month 12
CD22 expression
Time frame: Month 1 to Month 12
CD22 expression
Time frame: Month 1 to Month 12
Safety and tolerance of fractionated RIT with 90Y-epratuzumab tetraxetan assessed by NCI Criteria
Time frame: Month 1 to Month 12
Immunization test to search for antibodies by ELISA test
Time frame: Month 1 to Month 6
Realization of a blood pharmacokinetics profile of 111In /90Y-epratuzumab tetraxetan
Time frame: 1 week after 90Y-epratuzumab tetraxetan injection
Tumour and organ dosimetry of 90Y-epratuzumab tetraxetan assessed using 111In-epratuzumab tetraxetan biodistribution
Time frame: 1 week after 90Y-epratuzumab tetraxetan injection
Correlation between FLT3-ligand serum value and efficacy and toxicity after treatment
Time frame: Month 1 to Month 12
Relapse incidence: overall and comparison between both groups
Time frame: Month 1 to Month 12
Relapse incidence: overall and comparison between both groups
Time frame: Month 1 to Month 12
Minimal Residual Disease (MRD) (by FACS analysis)
Time frame: Month 1 to Month 12
Minimal Residual Disease (MRD) (by FACS analysis)
Time frame: Month 1 to 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 19 Jan 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 90Y-epratuzumab tetraxetan and chemotherapy/ immunotherapy in people with CD22+ Relapsed/Refractory B-ALL, run by Nantes University Hospital at 1 site in France.
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 33 inclusion and 0 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 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
Compare the complete response rate (CR + CRp) in the two arms (time frame: Week 4 to Week 6). 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 19 Jan 2017.