Paediatric Oncology & Haematology Trials by

Inclusion/Exclusion

catleeman — 2022-06-07 08:02:02 UTC

Inclusion criteria
• Diagnosis of AML
• Age <18 years at trial entry
• No prior chemotherapy or biological therapy
• Normal cardiac function
• Fit for protocol chemotherapy
• Documented negative pregnancy
• Patient agrees to use effective contraception (patients of childbearing potential)
• Written informed consent

Exclusion criteria for all randomisations
• Acute Promyelocytic Leukaemia
• Down Syndrome
• Blast crisis of chronic myeloid leukaemia
• Relapsed or refractory AML
• Bone marrow failure syndromes
• Concurrent treatment or administration of any other experimental drug or with any other biological therapy for AML/high risk MDS/isolated MS
• Pregnant or lactating females

Key Contact Details

eliselongworth1 — 2022-06-07 11:04:16 UTC

PI - Dr Bhatnagar
Research Nurses - Elise Longworth, Becca Walker & Beckie Weaver 01865 234982
Trials Practitioner - Evie Pearson 01865 227747

Email - paedhaem.oncresearch@nhs.net

Inclusion/Exclusion

eliselongworth1 — 2022-06-07 11:27:38 UTC

Inclusion criteria

Definitive diagnosis of Langerhans cell histiocytosis
Age less 18 years at time of definitive diagnosis
Met inclusion criteria for the respective stratum
Signed written informed consent

Exclusion criteria

Stratum dependent

Key Contact Details

eliselongworth1 — 2022-06-07 11:27:57 UTC

PI - Dr Amy Mitchell
Research Nurses - Elise Longworth, Becca Walker & Beckie Weaver 01865 234982
Trials Practitioner - Evie Pearson 01865 227747

Email - paedhaem.oncresearch@nhs.net

Inclusion/Exclusion

eliselongworth1 — 2022-06-07 11:35:34 UTC

Inclusion criteria - for trial entry only

Histologically confirmed diagnosis of RMS (except pleomorphic RMS)
Written informed consent from the patient and/or the parent/legal guardian

**specific inclusion/exclusion criteria for separate randomisations can be found in the trial protocol**

Inclusion/Exclusion

eliselongworth1 — 2022-06-09 09:23:33 UTC

Inclusion Criteria:

Patients with newly diagnosed T-lineage or precursor B-cell ALL.
Age between 1-45 years*.
Written informed consent from parents/guardians and patient

Exclusion Criteria:

Age ≥46 years at diagnosis.
Age <365 days at diagnosis.
Patients with a previous malignant diagnosis.
Relapse of ALL
Mature B-ALL
Philadelphia positive ALL
Treatment with systemic corticosteroids for more than one week and/or other chemotherapeutic agents within 4 weeks prior to diagnosis.

ALL2G

eliselongworth1 — 2022-06-10 11:37:20 UTC

Key Contact Details

eliselongworth1 — 2022-06-13 10:59:37 UTC

PI - Dr Amrana Quereshi
Research Nurses - Elise Longworth, Becca Walker & Beckie Weaver 01865 234982
Trials Practitioner - Evie Pearson 01865 227747

Email - paedhaem.oncresearch@nhs.net

Key Contact Details

eliselongworth1 — 2022-06-13 11:00:21 UTC

PI - Dr Esther Blanco
Research Nurses - Elise Longworth, Becca Walker & Beckie Weaver 01865 234982
Trials Practitioner - Evie Pearson 01865 227747

Email - paedhaem.oncresearch@nhs.net

Inclusion/Exclusion

catleeman — 2022-06-28 13:07:59 UTC

Inclusion Criteria:

Metastatic Neuroblastoma/metastatic response during chemo
Previous High Risk Neuroblastoma treated with High Risk NB SIOPEN
Written informed consent from parents/guardians and patient

Exclusion Criteria

Brain metastasis
Previous high dose therapy
Performance status <70% (Karnofsky or Lansky)
Peanut or Soya allergy
Inflammatory bowel disease

Key Contact Details

catleeman — 2022-06-28 13:16:49 UTC

PI - Dr Esther Blanco
Research Nurses Elise Longworth, Becca Walker, Beckie Weaver 01865 234982
Trials Practitioner Evie Pearson 01865 227747

Key Contact Details

catleeman — 2022-06-28 13:35:48 UTC

PI - Dr Sarah Pratap
Research Nurses Elise Longworth, Becca Walker, Beckie Weaver 01865 234982
Trials Practitioner Evie Pearson 01865 227747

Key Contact Details

catleeman — 2022-06-28 13:37:13 UTC

PI - Dr Amy Mitchell
Research Nurses Elise Longworth, Becca Walker, Beckie Weaver 01865 234982
Trials Practitioner Evie Pearson 01865 227747

Inclusion/Exclusion

catleeman — 2022-06-28 13:46:13 UTC

Inclusion Criteria

All children, adolescents or young adults with a primary renal tumour (or extra-renal Wilms tumour)

Exclusion Criteria

Patients who do not give/whose parents/guardians do not give consent for inclusion of their clinical/imaging or biological sample data

NB: patients/parents can consent separately to the biological studies so may still be registered if they consent for inclusion of their clinical/imaging data but will be excluded from the biological studies if they so wish

LCH

eliselongworth1 — 2022-07-04 10:12:16 UTC

Key Contact Details

eliselongworth1 — 2022-07-06 09:40:33 UTC

PI - Dr Amy Mitchell
Research Nurses Elise Longworth, Becca Walker, Beckie Weaver 01865 234982
Trials Practitioner Evie Pearson 01865 227747
Email - paedhaem.oncresearch@nhs.net

Inclusion/Exclusion

eliselongworth1 — 2022-07-06 10:08:27 UTC

Inclusion Criteria

Primary Wilms tumour

Exclusion Criteria

Patients who do not give consent for inclusion of their clinical/imaging or biological sample data
patients/parents can consent separately to the biological studies so may still be registered if they consent for inclusion of their clinical/imaging data but will be excluded from the biological studies if they so wish

Sample requirements

eliselongworth1 — 2022-07-06 10:14:23 UTC

4mls blood in EDTA

Diagnosis
Mid chemotherapy
Pre & Post nephrectomy/renal sparing surgery
End of treatment

Inclusion/Exclusion

eliselongworth1 — 2022-07-06 16:27:50 UTC

Inclusion Criteria - group 1

Age 4-25yrs old
New ALL/LBL

Inclusion Criteria - group 2

Age 1-25
Previous diagnosis of ALL/LBL
Documented central neurological toxicity

Exclusion Criteria - group 1

Previous neurodevelopmental disorder
Visual impairment
Relapsed or secondary cancer

Exclusion Criteria - group 2

Neurological symptoms secondary to cerebral sinus venous thrombosis
Neurological symptoms secondary to peripheral neuropathy
Clear cause for neurological event eg. head injury

Study Requirements

eliselongworth1 — 2022-07-06 16:30:55 UTC

CogState software program (series of short games aimed at assessing processing speed, attention, visual recognition, working memory and executive ability

CSF BIOMARKERS 1-2 mls at time of theraputic LP

DNA FOR GENOTYPING Saliva or BMA

eliselongworth1 — 2022-07-12 08:00:57 UTC

eliselongworth1 — 2022-07-12 08:06:51 UTC

eliselongworth1 — 2022-07-12 08:33:16 UTC

eliselongworth1 — 2022-07-12 10:03:27 UTC

eliselongworth1 — 2022-07-12 11:55:35 UTC

eliselongworth1 — 2022-07-12 11:55:51 UTC

eliselongworth1 — 2022-07-12 11:56:09 UTC

Inclusion/Exclusion

eliselongworth1 — 2022-07-12 12:01:45 UTC

Inclusion criteria

Patients with a relapsed or refractory paediatric tumour
For solid tumours: FFPE tumour or fresh frozen tumour available within 8 weeks prior to trial entry
For leukaemia: Viable fresh or frozen Bone Marrow aspirate sample taken within 8 weeks prior to trial entry
Written informed consent

Exclusion criteria

No relapse tissue available to send

Key Contact Details

eliselongworth1 — 2022-07-12 12:09:17 UTC

PI - Dr Shaun Wilson
Research Nurses Elise Longworth, Becca Walker, Beckie Weaver 01865 234982
Trials Practitioner Evie Pearson 01865 227747

Inclusion/Exclusion

eliselongworth1 — 2022-07-12 12:14:32 UTC

Inclusion criteria

Clinical diagnosis of HB and histologically defined diagnosis of HB or HCC.
Histological confirmation of HB is required except in emergency situations
Age ≤30 years
Written informed consent

Exclusion criteria

Any previous chemotherapy or currently receiving anti-cancer agents
Recurrent disease or secondary malignancy
Previously received a solid organ transplant
Uncontrolled infection

Key Contact Details

eliselongworth1 — 2022-07-12 12:14:53 UTC

PI - Dr Esther Blanco
Research Nurses Elise Longworth, Becca Walker, Beckie Weaver 01865 234982
Trials Practitioner Evie Pearson 01865 227747

Key Contact Details

eliselongworth1 — 2022-07-12 14:49:05 UTC

PI - Karen Sherbourne
Research Nurses Elise Longworth, Becca Walker, Beckie Weaver 01865 234982
Trials Practitioner Evie Pearson 01865 227747
Email - paedhaem.oncresearch@nhs.net

Inclusion/Exclusion

eliselongworth1 — 2022-07-15 13:04:24 UTC

Inclusion criteria

Age 0-18
A new diagnosis of a childhood cancer

Exclusion criteria

Age at diagnosis over 18
Patient not diagnosed in the UK
Parent/carer or young person unable to give informed consent

Key Contact Details

eliselongworth1 — 2022-07-15 13:07:25 UTC

PI - Jennie Moreton
Research Nurses Elise Longworth, Becca Walker, Beccie Wearver 01865 234982
Trials Practitioner Evie Pearson 01865 227747

eliselongworth1 — 2022-07-15 13:09:50 UTC

Inclusion/Exclusion

eliselongworth1 — 2022-07-15 13:12:43 UTC

Inclusion criteria

Aged 13-25yrs
First cancer diagnosis
Cancer requiring treatment (chemotherapy, radiotherapy or surgery)

Exclusion criteria

Not requiring treatment

eliselongworth1 — 2022-07-15 13:14:12 UTC

Study Requirements

eliselongworth1 — 2022-07-15 13:30:53 UTC

Serum sample at diagnosis then at 1,2 & 3 yrs post diagnosis

Data collection at diagnosis then at 1,2 & 3 yrs post diagnosis

Study Requirements

eliselongworth1 — 2022-07-15 13:34:34 UTC

FFPE tissue from relapse biopsy (frozen tissue not mandatory but recommended)
Blood for germline & circulating DNA
Diagnostic tissue from primary malignancy & all subsequent relapses (FFPE)

Bone marrow from latest relapse/refractory episode
CSF (as above but not mandatory)

Inclusion/Exclusion

eliselongworth1 — 2022-08-09 08:23:06 UTC

Inclusion criteria

Age 1-17 years
Enrolled on ALL2Together1

Exclusion criteria

Trisomy 21
Chronic active arthritis
Contra-indication to flouroquinolones

eliselongworth1 — 2022-08-09 08:36:21 UTC

eliselongworth1 — 2022-08-09 08:39:35 UTC

Study Requirements

Stool sample or peri-rectal swab
Completion of QoL Questionnaire

At baseline, day 15, week 6, start of maintenance and at 12 months

Daily diary for 5 weeks

Inclusion/Exclusion

eliselongworth1 — 2022-08-31 10:24:33 UTC

Inclusion Criteria

Histologically confirmed diagnosis of medulloblastoma
Age over 3yrs at diagnosis (date of initial surgery)
No prior oncological treatment
Adequate hepatic, renal & haematological function

Exclusion Criteria

Patients with significant residual tumour (> 1.5 cm2) following surgical resection of the primary tumour
Chang Stage M4 disease
Brainstem or embryonal tumours in other sites
Patients previously treated for any type of malignant disease
Medical contraindication to radiotherapy or chemotherapy

eliselongworth1 — 2022-08-31 10:27:04 UTC

Study Requirements

eliselongworth1 — 2022-08-31 10:41:45 UTC

Diagnosis

Snap frozen tissue from initial surgery
FFPE block
Whole blood
CSF

Relapse

Snap frozen tissue
FFPE Block

QoS Questionnaire

Post surgery, pre induction chemotherapy
2yrs post diagnosis
5yr post diagnosis
at age 18

Neurocognitive Assessments

Post surgery or up to 2 weeks into Rx
2yrs post diagnosis
5yr post diagnosis
at age 18

eliselongworth1 — 2022-08-31 10:43:44 UTC

Key Contact Details
PI - Shaun Wilson
Research Nurses - Elise Longworth, Rebecca Walker & Rebecca Weaver 01865 234982
Trials Practitioner - Evie Pearson 01865 227747
Email - paedhaem.oncresearch@nhs.net

eliselongworth1 — 2022-09-02 10:49:34 UTC

eliselongworth1 — 2022-09-02 10:52:57 UTC

eliselongworth1 — 2022-09-02 10:59:52 UTC

Inclusion/Exclusion

eliselongworth1 — 2022-09-02 11:05:27 UTC

Inclusion Criteria:

Age >1yr & <21yrs
New diagnosis of ALL with definitive evidence of BCR-ABL-1Fusion, FISH or RT-PCR
Must have already started induction but received less than 14 day of treatment
Diagnostic BMA available
Adequate liver, renal and cardiac function

Exclusion Criteria:

Known CML
ALL as secondary cancer
Down syndrome
Current PHDU/PICU level supportive care

eliselongworth1 — 2022-09-02 11:12:06 UTC

Key Contact Details

eliselongworth1 — 2022-09-02 11:14:08 UTC

PI - Dr Neha Bhatnagar
Research Nurses - Elise Longworth, Becca Walker & Beckie Weaver 01865 234982
Trials Practitioner - Evie Pearson 01865 227747

Email - paedhaem.oncresearch@nhs.net

Study Requirements

eliselongworth1 — 2022-09-02 11:21:11 UTC

Study Requirements

eliselongworth1 — 2022-09-09 12:29:07 UTC

At diagnosis: BMA x2, Blood x2, frozen tissue, FFPE & H&E slides
Blood (at different timepoints in induction dependent on risk)
At relapse: BMA x2, Blood x2, frozen tissue, FFPE & H&E slides

Inclusion/Exclusion

eliselongworth1 — 2022-09-09 12:35:42 UTC

Inclusion criteria

Disease recurrence or progression after completing first line treatment OR refractory disease
Soft tissue disease component evaluable by cross-sectional imaging (RECIST)
Age ≥4 years and <50 years

Exclusion Criteria

Bone marrow infiltration resulting in ANC of <1.0 x10⁹/L or platelets <75 x 10⁹/L.
Cytotoxic chemotherapy or other IMP within previous 2 weeks.
Myeloablative therapy within previous 8 weeks.
Radiotherapy to target lesion within previous 6 weeks.

eliselongworth1 — 2022-09-09 12:36:44 UTC

Study Requirements

eliselongworth1 — 2022-09-09 12:47:41 UTC

eliselongworth1 — 2022-09-09 12:50:36 UTC

Inclusion/Exclusion

eliselongworth1 — 2022-09-16 09:37:30 UTC

Inclusion Criteria

Age <22yrs
Newly diagnosed intracranial or spinal ependymoma
FFPE tissue

Exclusion Criteria

WHO Grade 1 ependymoma
Spinal cord tumour
Co-enrolment in other ependymoma trial
Family Hx of severe epilepsy
Hepatic & renal impairment

eliselongworth1 — 2022-09-16 10:05:38 UTC

eliselongworth1 — 2022-09-16 10:06:00 UTC

eliselongworth1 — 2022-09-16 10:06:13 UTC

Study Requirements

eliselongworth1 — 2022-09-16 10:12:25 UTC

eliselongworth1 — 2022-09-16 10:12:49 UTC

eliselongworth1 — 2022-09-16 10:13:50 UTC

SIV

eliselongworth1 — 2022-09-30 09:39:27 UTC

Inclusion/Exclusion

eliselongworth1 — 2022-09-30 10:02:01 UTC

Inclusion Criteria
(R1 RAPID COJEC/GPOH)

Stage M neuroblastoma over 1yr with any MYCN Status

Stage L2, M or Ms neuroblastoma with MYCN amplification at any age
No previous chemotherapy (except 1 cycle of Carbo/Etop allowed)

(R-HDC Single HDC Bu-Mel/Tandem HDC Thiotepa + Bu-Mel) randomised at end of induction

over age 1yr Stage M neuroblastoma
Complete or partial response at metastatic sites
Stem cells available

(R-RTx local radiotherapy) treatment allocated after disease evaluation post HDC & surgery

eliselongworth1 — 2022-09-30 10:03:01 UTC

eliselongworth1 — 2022-09-30 10:18:06 UTC

Key Contact Details

eliselongworth1 — 2022-09-30 10:32:32 UTC

PI - Dr Esther Blanco
Research Nurses - Elise Longworth, Becca Walker & Beckie Weaver 01865 234982
Trials Practitioner - Evie Pearson 01865 227747

Email - paedhaem.oncresearch@nhs.net

eliselongworth1 — 2022-10-04 08:34:37 UTC

eliselongworth1 — 2022-10-04 08:36:54 UTC

Neurotoxicity in ALL

eliselongworth1 — 2022-10-28 12:44:41 UTC

20-50% of long term survivors will experience neurotoxicities eg. methotrexate stroke-like symptoms, PRES, problems with memory/attention/processing speeds.

Cogstate Games:

Detection Task (Processing speed)
•Identification Task (Attention/Vigilance)
•One Card Learning Task (Visual Recognition Memory)
•One Back Memory Task (Working Memory
•The Groton Maze Learning Task (Problem Soling, Attention Span, Spatial Memory and Reasoning

Inclusion/Exclusion

eliselongworth1 — 2022-11-18 13:09:22 UTC

Inclusion Criteria

age 4 - 21yrs
Confirmed childhood cancer diagnosis or
First relapse of childhood cancer
Enrolment must occur within 8 weeks of starting anti-cancer treatment

Exclusion Criteria

cancer diagnosis not requiring either chemotherapy, radiotherapy or solely requiring surgery
patient unsuitable after assessment by treating team (medical, psychological reasons etc)

Study Requirements

eliselongworth1 — 2022-11-18 13:11:38 UTC

eliselongworth1 — 2022-11-18 13:14:33 UTC

Key Contact Details

eliselongworth1 — 2022-11-18 13:18:11 UTC

Research Assisstant - Hayley Marriott 01865 484260 hmarriott@brookes.ac.uk

eliselongworth1 — 2022-11-23 09:12:15 UTC

eliselongworth1 — 2022-12-06 14:15:15 UTC

eliselongworth1 — 2022-12-06 14:29:09 UTC

Vindesine

eliselongworth1 — 2023-01-25 14:36:58 UTC

Pegylated G-CSF

eliselongworth1 — 2023-01-25 14:57:45 UTC

Given in GPOH randomisation only (not Rapid COJEC) as 3 weeks between cycles.