Trial purpose
Cancer treatment
Tumor type
Haematological
Age
<18
Clinical summary
Summary
In this trial, patients will be assigned to one of two treating arms, according to whether a matched donor is available. In Arm 1, patients who have no fully matched brothers or sisters, volunteer donors or umbilical cord blood units available will receive a TCR a+ß+/CD19+ cell depleted graft from a parent donor. Control patients (Arm 2) will receive a standard bone marrow transplant from another donor (e.g., volunteer donor) as per institutional practice. All patients enrolled in this trial will have regular clinical assessments for two years post-transplant to evaluate the efficacy of their treatment. Further information, such as quality of life and carer burden, will be collected for up to 5 years post-transplant.
Conditions
This trial is treating people with haematological (blood) cancer
Eligibility
Inclusion
A patient must meet the following criteria to be eligible for inclusion of Arm 1 of the study:
• Aged less than 18 years
• The availability of a HLA matched haploidentical donor greater or equal to 5/10
• Absence of readily available matched sibling donor
• Absence of other readily available non-related donors:
- Unrelated volunteer donors; HLA match less than 9/10
- UCB units with adequate cell dose; HLA match less than 5/6 on low resolution typing or HLA match less than 6/8 on high resolution typing (8/8 HLA match for non malignant patients)
• Adequate organ function
• Female patients of child bearing age are not pregnant
• Written consent of the patient’s legal guardian, and assent from the patient if age appropriate
Exclusion
• Patient has undergone HSCT within the last 180 days
• Evidence of HIV infection
• Current uncontrolled bacterial or fungal infection
• The treatment protocol in part or in its entirety is declined by either the patient or their legal guardian
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Miltenyi Biotech ,Children's Cancer Foundation,Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)
Scientific Title
TCR a+ß+/CD19+ cell depleted haploidentical donor stem cell transplantation for paediatric patients
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