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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02670564




Registration number
NCT02670564
Ethics application status
Date submitted
3/07/2015
Date registered
2/02/2016

Titles & IDs
Public title
ALL SCTped FORUM - Pharmacogenomic Study (add-on Study)
Scientific title
Allogeneic Stem Cell Transplant for Children and Adolescents With Acute Lymoblastic Leukemia FORUM - Pharmacogenomic Study (add-on Study)
Secondary ID [1] 0 0
NZ 2015-069
Secondary ID [2] 0 0
ZH 2014-0535
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pharmacogenomics
Other interventions - Busulfan plasma level measurements

Experimental: Total body irradiation (TBI) - The Pharmacogenomics add-on requires 2X 5ml blood EDTA for further DNA analyses.

Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.

Experimental: Busulfan - The Pharmacogenomics add-on requires 2X 5ml blood EDTA for further DNA analyses.

Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.

Experimental: Treosulfan - The Pharmacogenomics add-on requires 2X 5ml blood EDTA for further DNA analyses.

Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.


Treatment: Other: Pharmacogenomics
Blood samples (2x5ml EDTA tubes) should be collected just before the start of the conditioning regimen from every patient regardless of therapeutic arm by every centre and stored =-20°C Patient should be in remission (MRD negative) for this sampling, otherwise the sample should be taken using a mouth swab/saliva (not intravenously).

For second transplant patients, please provide DNA taken before first transplant or a fresh saliva samples.

Other interventions: Busulfan plasma level measurements
Bu PK analysis after the first dose of IV Bu (+potential subsequent ones).

Blood sampling:

-\>For Bu 4 X/d: Before the first Bu dose (Time 0), then straight after the end of infusion (Time 1), then at 15 min (Time 2), 30 min (Time 3), 1 hour (Time 4) and 4 hour (Time 5) after the end of infusion

-\>For Bu 1 X/d: Before the first Bu dose (Time 0), then straight after the end of infusion (Time 1), then at 1 hour (Time 2), 3 hour (Time 3), 5 hour (Time 4), 7 hour (Time 5) and 11 hour (Time 6) after the end of infusion.

For centers not performing BU TDM, perform Dried Blood Sampling (DBS) analysis:

-\> 0.5ml blood sample should be collected and 5µl spotted onto DBS cards in duplicate. Dry them max 5 hours and then keep in a sealed envelope and store at -80°C, as below
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Genetic variants in participants as a marker of risk of Adverse events and/or Efficacy of the studied agents
Assessment method [1] 0 0
Genotyping of candidates genes related to pharmacokinetics and pharmacodynamics of the studied agents. Association study between the herein genetic variants and the below mentioned phenotypes (odd ratio).
Timepoint [1] 0 0
through study completion, an average of 2 years
Secondary outcome [1] 0 0
Number of participants with acute Graft-versus-host disease (aGvHD) according to the Glucksberg scale and Seattle criteria
Assessment method [1] 0 0
Timepoint [1] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [2] 0 0
Number of participants with chronic Graft-versus-host disease (cGvHD) according to the Glucksberg scale and Seattle criteria
Assessment method [2] 0 0
Timepoint [2] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [3] 0 0
Number of participants with VOD/SOS according to the Seattle criteria
Assessment method [3] 0 0
Timepoint [3] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [4] 0 0
Number of participants with Neutrophil recovery as a measure of Safety and Tolerability
Assessment method [4] 0 0
defined as the first of 3 consecutive days with an absolute neutrophil count of 0.5x10\^9/L or higher
Timepoint [4] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [5] 0 0
Number of participants with Platelet recovery as a measure of Safety and Tolerability
Assessment method [5] 0 0
Defined as the first of 3 consecutive days with platelet counts higher that 20x10\^9/L without transfusion
Timepoint [5] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [6] 0 0
Number of participants with Primary graft failure or rejection as a measure of Safety and Tolerability
Assessment method [6] 0 0
Defined by persistent pancytopenia with no evidence of hematologic recovery of donor cells beyond 28 days after transplantation, and secondary graft failure by a rapid decrease in neutrophil count after successful engraftment
Timepoint [6] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [7] 0 0
Transplant related mortality (TRM)
Assessment method [7] 0 0
the time of transplant until all causes of death after transplant not related to relapse
Timepoint [7] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [8] 0 0
Event free survival (EFS)
Assessment method [8] 0 0
the time of transplant until death, relapse or graft failure, whichever occurs first.
Timepoint [8] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [9] 0 0
Overall survival (OS)
Assessment method [9] 0 0
the time between transplantation and death due to any causes
Timepoint [9] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [10] 0 0
Cumulative incidence of relapse
Assessment method [10] 0 0
Timepoint [10] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years

Eligibility
Key inclusion criteria
Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.

Gender

* Both: both female and male participants are being studied

Age Limits

* Minimum Age: N/A
* Maximum Age: age at time of screening less than 18 years old

Accepts Healthy Volunteers: no

Eligibility Criteria



* Patients with ALL (except for patients with B-ALL)
* indication for allogeneic HSCT
* complete remission (CR) before HSCT
* written consent of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form"
* no pregnancy
* no secondary malignancy
* no previous HSCT
* HSCT is performed in a study participating centre
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non Hodgkin-Lymphoma
* ALL with extramedullary involvement with indication for TBI
* CNS involvement at the timepoint of screening
* Trisomy 21
* The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
* No consent is given for saving and propagation of anonymous medical data for study reasons
* Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
* Karnofsky / Lansky score < 50%
* Subjects unwilling or unable to comply with the study procedures

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Switzerland
State/province [1] 0 0
Cansearch Laboratory
Country [2] 0 0
Switzerland
State/province [2] 0 0
Basel
Country [3] 0 0
Switzerland
State/province [3] 0 0
Geneva
Country [4] 0 0
Switzerland
State/province [4] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Other
Name
Swiss Pediatric Oncology Group
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ALL SCTped Forum
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Christina Peters, Prof. MD PhD
Address 0 0
St. Anna Kinderspital, Vienna, Austria
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marc Ansari, MD, PD
Address 0 0
Country 0 0
Phone 0 0
+41 22 382 47 31
Email 0 0
Marc.Ansari@hcuge.ch
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02670564