90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia (RITII)
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|ClinicalTrials.gov Identifier: NCT04856215|
Recruitment Status : Not yet recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: 90-Yttrium-labelled anti-CD66 monoclonal antibody||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2024|
Experimental: 90-Yttrium-labelled anti-CD66 monoclonal antibody
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.
Drug: 90-Yttrium-labelled anti-CD66 monoclonal antibody
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.
- 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.
- 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 timing of myeloid and platelet engraftment after allogeneic hematopoietic stem cell transplantation.
- 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 ]Assessment of chimerism on bone marrow and peripheral blood to confirm engraftment of donor origin.
- Safety Outcome [ Time Frame: through study completion, upto 2 years post study ]Toxicity will be classified using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856215
|Contact: Sponsor||(0) 20 7905 2000 ext email@example.com|
|Principal Investigator:||Robert Chiesa||Great Ormond Street Hospital|