CompletedPhase 1

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

United Kingdom9 participantsStarted 2016-05

Plain-language 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).

Who can participate

Age range1 Year – 18 Years

SexALL

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Inclusion criteria

✓. 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;

What they're measuring

maximum tolerated dose (MTD)

Timeframe: 45 days post transplant

dose limited toxicity (DLT)

Timeframe: 45 days post transplant

Trial details

NCT IDNCT04082286

SponsorGreat Ormond Street Hospital for Children NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-14

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