LeukemiaPhase 2RITIINCT04856215
90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia
A Phase 2 study testing 90-Yttrium-labelled anti-CD66 monoclonal antibody in people with Leukemia, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Children affected by high risk or relapsed/refractory leukaemia have a poor prognosis, with an increased risk of relapse. These patients generally need treatment intensification and a bone marrow transplantation (BMT). Nevertheless, with conventional treatent the risk of relapse after transplant remains high. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Leukemia
- What is being tested?
- 90-Yttrium-labelled anti-CD66 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 29 Sep 2023to 30 Sep 2025
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- An underlying hematological malignancy including:
- relapse of AML after allogeneic hematopoietic stem cell transplantation; b) relapse of ALL after allogeneic hematopoietic stem cell transplantation; c) relapse of JMML after allogeneic hematopoietic stem cell transplantation; e) refractory ALL; f) refractory AML; g) high risk infant ALL;
- be ≥ 0.5 year old and ≤ 18 years old;
- must not be eligible for therapy of higher curative potential. Where an alternative therapy has been shown to prolong survival in an analogous population, this should be offered to the patient prior to discussing this study;
- have a Karnofsky Performance Status ≥ 50 or Lansky Performance Status ≥ 30;
- provide signed, written informed consent from parent or guardian;
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- be able to comply with study procedures and follow-up examinations;
- have adequate cardiac function (irrespective of concomitant cardio-vascular treatment) at PI/CI discretion;
- have adequate organ function (as indicated by Table 5) within 30 days prior to 111In infusion;
- patients who have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrolment;
- be negative for human-anti-murine antibodies (HAMA).
Who cannot join
- patients who are positive for human anti-murine antibodies (HAMA);
- patients with compromised organ function within 30 days prior to 111In infusion;
- patients with isolated CNS disease relapse*;
- patients with an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment;
- Pregnant or breast-feeding females are excluded due to potential risks of foetal adverse events of an investigational agent. Pregnancy tests must be obtained prior to enrolment on this study for girls of reproductive potential. The need to commence pregnancy testing will be at the discretion of the treating physician to facilitate taking in to account factors such as precocious puberty, endocrine status and medications which can affect pubertal status. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Sexual Abstinence is an acceptable method of birth control**.
- patients with any other severe concurrent disease, which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study;
- patients with extensive chronic graft versus host disease (GVHD);
- patients with unstable cardio-vascular disease. -
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Great Ormond Street Hospital NHS Foundation Trust
London
Robert Chiesa, Prof. Dr., robert.chiesa@gosh.nhs.uk
Robert Chiesa
- Not yet recruiting
University College London Hospital NHS Trust
London
Rachel Hough, rachaelhough@nhs.net
Rachel Hough
About this study
Official title: 90Yttrium-labelled Anti-CD66 Monoclonal Antibody as Part of a Reduced Toxicity Conditioning Regimen Prior to Allogeneic Haematopoietic Stem Cell Transplantation: an Open Label, Phase II Study in Children and Adolescents With High Risk Leukaemia
Children affected by high risk or relapsed/refractory leukaemia have a poor prognosis, with an increased risk of relapse. These patients generally need treatment intensification and a bone marrow transplantation (BMT).
Nevertheless, with conventional treatent the risk of relapse after transplant remains high.
Radioimmunotherapy provides a way to deliver high dose irradiation to the bone marrow (where leukaemia resides), while sparing normal organs and tissues from its toxicity.This can be achieved by linking a radioactive molecule (Yttrium90) to an antibody that, once infused in the blood, targets marrow/leukemic cells.
Read the detailed description
In our Phase 1 trial which concluded in 2019, 9 children affected by refractory or relapsed leukaemia were enrolled at Great Ormond Street Hospital or UCLH. Participants received infusion of a tumour cell targeting antibody to deliver irradiation to the bone marrow and sites containing leukemic blasts prior to BMT. The aim of the Phase 1 study was to identify the dose limiting toxicity and maximum tolerated dose of targeted radiotherapy, and it was found that this treatment was well tolerated with minimal infusion-related side effects.
The current study will enrol a larger cohort of children (aged 0.5 - 18 years) who will receive 90Yttrium administered at an infused activity to target the optimal absorbed dose to the bone marrow. Patients will be treated at GOSH and UCLH and followed up for 12 months post-BMT to evaluate safety and efficacy of targeted radiotherapy with a reduced toxicity conditioning regimen prior to BMT.
PURPOSE AND DESIGN OF THE STUDY Children with high risk or relapsed leukaemia have a poor prognosis with an increased risk of relapse after standard bone marrow transplant. There is an urgent need to offer a different therapeutic strategy for children with such poor risk diseases.
There is evidence that targeted radioimmunotherapy prior to a stem cell transplantation is a feasible and effective treatment that delivers high dose radiation to the bone marrow and spleen (where leukaemia resides),while sparing other tissues and organs from its toxicity. Since leukaemic cells are generally radiosensitive, this approach might increase leukaemia-free survival, while reducing transplant-related morbidity and mortality.
Our previous phase 1 radio-immunotherapy study demonstrated that radio-immunotherapy is non-toxic, but can elicit myelosuppression, with potential for better disease eradication.
This protocol offers a novel and non-toxic therapeutic strategy to children with poor risk leukaemia and aims at reducing the risk of disease relapse after transplant.
RECRUITMENT and CONSENT Children with poor risk leukaemia who fulfill the inclusion and exclusion criteria of this study might be recruited in this trial. Patients and/or their parents will receive appropriate information from one of the investigators regarding the rationale of this study, the possible risks and benefits and the alternatives to taking part. Patients and/or their parents will be given an age appropriate information sheet and consent form and they will be given the time to think about this.
INCLUSION/EXCLUSION CRITERIA Children enrolled in this study must be affected by high risk or relapsed/refractory leukaemia, with a high risk of disease relapse after conventional transplant. Children eligible for this treatment must also be clinically fit for an allogeneic haematopoietic stem cell transplantation, according to clinical and laboratory parameters, which have been specified in details in the protocol.
RISKS, BURDENS AND BENEFITS Patients eligible for this trial are affected by high risk or relapsed/refractory leukaemia and have an indication to an allogeneic stem cell transplantation. Stem cell transplantation carries a significant risk of morbidity/mortality, due to: a)the toxicity of the preparative regimen, b) the posttransplant immunodeficiency with high risk of opportunistic infections, and c) the possible occurrence of graft versus host disease. The use of radioimmunotherapy in the context of a reduced toxicity conditioning regimen prior to the transplantation has proved to be feasible and safe in adult and paediatric studies, without a significant increase of the treatment related toxicity when compared to standard conditioning regimen.
Moreover, higher doses of radiation delivered to patients with leukaemia generate a better leukaemia response and this approach in children with poor risk leukaemia is promising.
Children undergoing this treatment will be carefully followed up and haematological (prolonged cytopaenia, stromal damage) and nonhaematological (mucositis, liver and kidney damage)toxicity will be monitored and recorded.
- Conditions
- Leukemia
- Being tested
- 90-Yttrium-labelled anti-CD66 monoclonal antibody
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90-Yttrium-labelled anti-CD66 monoclonal antibodyDrug
The Investigational Medicinal Product (IMP) consist of 1) 111Indium- and 2) 90Yttrium-labelled anti-CD66 (BW250/183) monoclonal antibody.
The anti-CD66 is a murine IgG1 monoclonal antibody originally developed as an in vivo leucocyte and bone marrow imaging agent (Boßlet 1985, Thomsen 1991). BW 250/183 anti-CD66 is a murine IgG1 kappa monoclonal antibody, originally produced as an anti-CEA antibody.
The batch of antibodies required for treatment will be radiolabelled by Royal Free Hospital radiology team with Indium 111 and Y90 for patient.
| Study group | Role | What they receive |
|---|---|---|
| 90-Yttrium-labelled anti-CD66 monoclonal antibody | Experimental | The medicinal product consists of the murine IgG1 anti-CD66 monoclonal antibody radio-labelled with 111In for imaging and dosimetry and with 90Y for therapy.
Dosage indications The [111In]-labeled anti-CD66 monoclonal antibody (MAb) will be given at an infused activity of 100MBq/sqm between 1-4 weeks before the therapeutic dose of radiolabelled antibody.
[90Y]-yttrium-labeled anti-CD66 MAb will be given as a single infusion on day - 14 prior to transplant. [90Y]-yttrium labelled anti-CD66 MAb will be given to target an absorbed dose to the bone marrow of 45 Gy +/- 10%. The maximum dose to be delivered to the liver and the kidneys is 15 Gy and 10 Gy, respectively. Receives: Drug: 90-Yttrium-labelled anti-CD66 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease response after [90Y]-labelled anti-CD66 monoclonal antibody
recovery of normal hematopoiesis in the bone marrow, with blasts < 5% of lymphoid/myeloid cells and lack of evidence for residual leukemia using any informative cytogenetic/molecular marker. The number and proportion of patients who have a response will be provided in each cohort.
Measured: through study completion, upto 2 years post study
Secondary outcomes (3)
Assessment of timing of myeloid and platelet engraftment after allogeneic hematopoietic stem cell transplantation.
Assessment of timing of myeloid and platelet engraftment after allogeneic hematopoietic stem cell transplantation.
Measured: through study completion, upto 2 years post study
Assessment of chimerism on bone marrow and peripheral blood to confirm engraftment of donor origin.
Assessment of chimerism on bone marrow and peripheral blood to confirm engraftment of donor origin.
Measured: through study completion, upto 2 years post study
Safety Outcome
Toxicity will be classified using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0.
Measured: through study completion, upto 2 years post study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start29 Sep 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Chiesa, Principal investigator, Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856215
- Sponsor's protocol ID
- 17WA58
- Acronym
- RITII
- Status last verified
- Sep 2023
- First submitted
- 13 Apr 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 90Yttrium-labelled Anti-CD66 Monoclonal Antibody as Part of a Reduced Toxicity Conditioning Regimen Prior to Allogeneic Haematopoietic Stem Cell Transplantation: an Open Label, Phase II Study in Children and Adolescents With High Risk Leukaemia
- ClinicalTrials.gov ID
- NCT04856215
- Acronym / sponsor ID
- RITII / 17WA58
- Conditions
- Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 23 Apr 2021 (actual)
- 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.
Children affected by high risk or relapsed/refractory leukaemia have a poor prognosis, with an increased risk of relapse. These patients generally need treatment intensification and a bone marrow transplantation (BMT).
Nevertheless, with conventional treatent the risk of relapse after transplant remains high.
Radioimmunotherapy provides a way to deliver high dose irradiation to the bone marrow (where leukaemia resides), while sparing normal organs and tissues from its toxicity.This can be achieved by linking a radioactive molecule (Yttrium90) to an antibody that, once infused in the blood, targets marrow/leukemic cells.
Detailed description
In our Phase 1 trial which concluded in 2019, 9 children affected by refractory or relapsed leukaemia were enrolled at Great Ormond Street Hospital or UCLH. Participants received infusion of a tumour cell targeting antibody to deliver irradiation to the bone marrow and sites containing leukemic blasts prior to BMT. The aim of the Phase 1 study was to identify the dose limiting toxicity and maximum tolerated dose of targeted radiotherapy, and it was found that this treatment was well tolerated with minimal infusion-related side effects.
The current study will enrol a larger cohort of children (aged 0.5 - 18 years) who will receive 90Yttrium administered at an infused activity to target the optimal absorbed dose to the bone marrow. Patients will be treated at GOSH and UCLH and followed up for 12 months post-BMT to evaluate safety and efficacy of targeted radiotherapy with a reduced toxicity conditioning regimen prior to BMT.
PURPOSE AND DESIGN OF THE STUDY Children with high risk or relapsed leukaemia have a poor prognosis with an increased risk of relapse after standard bone marrow transplant. There is an urgent need to offer a different therapeutic strategy for children with such poor risk diseases.
There is evidence that targeted radioimmunotherapy prior to a stem cell transplantation is a feasible and effective treatment that delivers high dose radiation to the bone marrow and spleen (where leukaemia resides),while sparing other tissues and organs from its toxicity. Since leukaemic cells are generally radiosensitive, this approach might increase leukaemia-free survival, while reducing transplant-related morbidity and mortality.
Our previous phase 1 radio-immunotherapy study demonstrated that radio-immunotherapy is non-toxic, but can elicit myelosuppression, with potential for better disease eradication.
This protocol offers a novel and non-toxic therapeutic strategy to children with poor risk leukaemia and aims at reducing the risk of disease relapse after transplant.
RECRUITMENT and CONSENT Children with poor risk leukaemia who fulfill the inclusion and exclusion criteria of this study might be recruited in this trial. Patients and/or their parents will receive appropriate information from one of the investigators regarding the rationale of this study, the possible risks and benefits and the alternatives to taking part. Patients and/or their parents will be given an age appropriate information sheet and consent form and they will be given the time to think about this.
INCLUSION/EXCLUSION CRITERIA Children enrolled in this study must be affected by high risk or relapsed/refractory leukaemia, with a high risk of disease relapse after conventional transplant. Children eligible for this treatment must also be clinically fit for an allogeneic haematopoietic stem cell transplantation, according to clinical and laboratory parameters, which have been specified in details in the protocol.
RISKS, BURDENS AND BENEFITS Patients eligible for this trial are affected by high risk or relapsed/refractory leukaemia and have an indication to an allogeneic stem cell transplantation. Stem cell transplantation carries a significant risk of morbidity/mortality, due to: a)the toxicity of the preparative regimen, b) the posttransplant immunodeficiency with high risk of opportunistic infections, and c) the possible occurrence of graft versus host disease. The use of radioimmunotherapy in the context of a reduced toxicity conditioning regimen prior to the transplantation has proved to be feasible and safe in adult and paediatric studies, without a significant increase of the treatment related toxicity when compared to standard conditioning regimen.
Moreover, higher doses of radiation delivered to patients with leukaemia generate a better leukaemia response and this approach in children with poor risk leukaemia is promising.
Children undergoing this treatment will be carefully followed up and haematological (prolonged cytopaenia, stromal damage) and nonhaematological (mucositis, liver and kidney damage)toxicity will be monitored and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 90-Yttrium-labelled anti-CD66 monoclonal antibody | Experimental | Drug: 90-Yttrium-labelled anti-CD66 monoclonal antibodyThe medicinal product consists of the murine IgG1 anti-CD66 monoclonal antibody radio-labelled with 111In for imaging and dosimetry and with 90Y for therapy. Dosage indications The [111In]-labeled anti-CD66 monoclonal antibody (MAb) will be given at an infused activity of 100MBq/sqm between 1-4 weeks before the therapeutic dose of radiolabelled antibody. [90Y]-yttrium-labeled anti-CD66 MAb will be given as a single infusion on day - 14 prior to transplant. [90Y]-yttrium labelled anti-CD66 MAb will be given to target an absorbed dose to the bone marrow of 45 Gy +/- 10%. The maximum dose to be delivered to the liver and the kidneys is 15 Gy and 10 Gy, respectively. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- An underlying hematological malignancy including:
- be ≥ 0.5 year old and ≤ 18 years old;
- must not be eligible for therapy of higher curative potential. Where an alternative therapy has been shown to prolong survival in an analogous population, this should be offered to the patient prior to discussing this study;
- have a Karnofsky Performance Status ≥ 50 or Lansky Performance Status ≥ 30;
- provide signed, written informed consent from parent or guardian;
Key exclusion criteria (8 listed)
- patients who are positive for human anti-murine antibodies (HAMA);
- patients with compromised organ function within 30 days prior to 111In infusion;
- patients with isolated CNS disease relapse*;
- patients with an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment;
- Pregnant or breast-feeding females are excluded due to potential risks of foetal adverse events of an investigational agent. Pregnancy tests must be obtained prior to enrolment on this study for girls of reproductive potential. The need to commence pregnancy testing will be at the discretion of the treating physician to facilitate taking in to account factors such as precocious puberty, endocrine status and medications which can affect pubertal status. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Sexual Abstinence is an acceptable method of birth control**.
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 |
|---|---|---|
| 90-Yttrium-labelled anti-CD66 monoclonal antibodyThe Investigational Medicinal Product (IMP) consist of 1) 111Indium- and 2) 90Yttrium-labelled anti-CD66 (BW250/183) monoclonal antibody. The anti-CD66 is a murine IgG1 monoclonal antibody originally developed as an in vivo leucocyte and bone marrow imaging agent (Boßlet 1985, Thomsen 1991). BW 250/183 anti-CD66 is a murine IgG1 kappa monoclonal antibody, originally produced as an anti-CEA antibody. The batch of antibodies required for treatment will be radiolabelled by Royal Free Hospital radiology team with Indium 111 and Y90 for patient. | Drug | 90-Yttrium-labelled anti-CD66 monoclonal antibody |
Primary outcome
Disease response after [90Y]-labelled anti-CD66 monoclonal antibody
Time frame: through study completion, upto 2 years post study
recovery of normal hematopoiesis in the bone marrow, with blasts < 5% of lymphoid/myeloid cells and lack of evidence for residual leukemia using any informative cytogenetic/molecular marker. The number and proportion of patients who have a response will be provided in each cohort.
3 secondary outcomes
Assessment of timing of myeloid and platelet engraftment after allogeneic hematopoietic stem cell transplantation.
Time frame: through study completion, upto 2 years post study
Assessment of chimerism on bone marrow and peripheral blood to confirm engraftment of donor origin.
Time frame: through study completion, upto 2 years post study
Safety Outcome
Time frame: through study completion, upto 2 years post study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Robert Chiesa principal investigator
Great Ormond Street Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 90-Yttrium-labelled anti-CD66 monoclonal antibody in people with Leukemia, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 2 sites in United Kingdom.
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 8 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sponsor ((0) 20 7905 2000 ext. 2863, ctimp.safety@gosh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease response after [90Y]-labelled anti-CD66 monoclonal antibody (time frame: through study completion, upto 2 years post study). 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 3 Oct 2023.