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

NCT04082286 | Completed Phase 1 DMC

• 1 other identifier: 07MI05
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myeloblastic Leukemia; Acute Lymphoblastic Leukemia; Juvenile Myelomonocytic Leukemia

Outcome Measures

Primary Outcomes (2)

• maximum tolerated dose (MTD)

  targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

  45 days post transplant

• dose limited toxicity (DLT)

  targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

  45 days post transplant

Study Arms (1)

Radioimmunotherapy

EXPERIMENTAL

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

Interventions

Yttrium-90 labelled monoclonal antibody against CD66 OTHER

Also known as: Radioimmunotherapy

Radioimmunotherapy

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• An underlying haematological malignancy including:
• isolated bone marrow relapse of AML after allogeneic haematopoietic stem cell transplantation;
• isolated bone marrow relapse of ALL after allogeneic haematopoietic stem cell transplantation;
• bone marrow relapse of JMML after allogeneic haematopoietic stem cell transplantation;
• refractory AML (5-20% blasts in BM) with/without expression of CD66 on blasts;
• refractory ALL (5-20% blasts in BM) with/without expression of CD66 on blasts;
• refractory AML (\> 20% blasts in BM) with expression of CD66 on blasts;
• refractory ALL (\> 20% blasts in BM) with expression of CD66 on blasts;
• be ≥ 1 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;
• be able to comply with study procedures and follow-up examinations;
• have normal cardiac function without specific treatment;
• have adequate organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion;

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital for Children

London, WC1N3JH, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelomonocytic, Juvenile

Interventions

Radioimmunotherapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Combined Modality Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Yttrium-90 labelled monoclonal antibody against CD66
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3+3 Dose escalation study, patient will receive 111In-labelled anti-CD66 MoAb (dosimetry) and 90Yttrium-labelled anti-CD66 MoAb (for therapy)

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: May 1, 2016
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: June 25, 2021

Record last verified: 2020-10

Locations

GB (1)