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Yttrium-90 Anti CD66 Monoclonal Antibody in Childhood Relapsed/Refractory Leukaemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082286
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary:
The radio-labeled anti-CD66 monoclonal antibody (with 111In for dosimetry and 90Y for therapy) will be administered in the T11 North room, UCLH, while the reduced intensity conditioning regimen and the allogeneic hematopoietic stem cell transplant will be performed in 2 centers, according to the age of the patient: A) patients aged < 13 years will be transplanted at the Bone Marrow Transplantation Department, Great Ormond Street Hospital (GOSH), and B) patients aged 13-18 years will be transplanted at the Bone Marrow Transplantation Department, University College London Hospitals (UCLH).

Condition or disease Intervention/treatment Phase
Acute Myeloblastic Leukemia Acute Lymphoblastic Leukemia Juvenile Myelomonocytic Leukemia Other: Yttrium-90 labelled monoclonal antibody against CD66 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 3+3 Dose escalation study, patient will receive 111In-labelled anti-CD66 MoAb (dosimetry) and 90Yttrium-labelled anti-CD66 MoAb (for therapy)
Masking: None (Open Label)
Official Title: 90Yttrium-labelled Anti-CD66 Monoclonal Antibody as Part of a Reduced Intensity Conditioning Regimen Prior to Allogeneic Haematopoietic Stem Cell Transplantation: an Open Label, Dose Escalating Phase I Study in Children and Adolescents With Relapsed/Refractory Leukaemia
Study Start Date : May 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Radioimmunotherapy
Children affected by high risk malignant disorders will be receiving increasing infused activity of a radio-immune conjugated antibody as part of their conditioning regimen prior to alleogeneic stem cell transplantation
Other: Yttrium-90 labelled monoclonal antibody against CD66
Other Name: Radioimmunotherapy




Primary Outcome Measures :
  1. maximum tolerated dose (MTD) [ Time Frame: 45 days post transplant ]
    targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

  2. dose limited toxicity (DLT) [ Time Frame: 45 days post transplant ]
    targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. An underlying haematological malignancy including:

    1. isolated bone marrow relapse of AML after allogeneic haematopoietic stem cell transplantation;
    2. isolated bone marrow relapse of ALL after allogeneic haematopoietic stem cell transplantation;
    3. bone marrow relapse of JMML after allogeneic haematopoietic stem cell transplantation;
    4. refractory AML (5-20% blasts in BM) with/without expression of CD66 on blasts;
    5. refractory ALL (5-20% blasts in BM) with/without expression of CD66 on blasts;
    6. refractory AML (> 20% blasts in BM) with expression of CD66 on blasts;
    7. refractory ALL (> 20% blasts in BM) with expression of CD66 on blasts;
  2. be ≥ 1 year old and ≤ 18 years old;
  3. 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;
  4. have a Karnofsky Performance Status ≥ 50 or Lansky Performance Status ≥ 30;
  5. provide signed, written informed consent from parent or guardian;
  6. be able to comply with study procedures and follow-up examinations;
  7. have normal cardiac function without specific treatment;
  8. have adequate organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion;
  9. 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;
  10. be negative for human-anti-murine antibodies (HAMA). Exclusion criteria

1) patients with CNS disease; 2) patients with BM cellularity < 10%; 3) patients with ≥ 20% blasts in BM and no expression of CD66 on blasts; 4) patients who are positive for human-anti-murine antibodies (HAMA); 5) patients with compromised organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion; 6) patients with extensive chronic GvHD; 7) patients with an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment; 8) patients who are pregnant or lactating; 9) patients with any other severe concurrent disease, which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.


Information from the National Library of Medicine

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): NCT04082286


Contacts
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Contact: Robert Chiesa, Dr robert.chiesa@gosh.nha.uk

Locations
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United Kingdom
Great Ormond Street Hospital for Children Recruiting
London, United Kingdom, WC1N3JH
Contact: Robert Chiesa, Doctor       robert.chiesa@gosh.nhs.uk   
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04082286    
Other Study ID Numbers: 07MI05
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Juvenile
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs