Comparing 4 approaches for acute lymphoblastic leukaemia
Official title: Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
- Phase 2
- 4 groups
- Sites in Calgary, Montreal and 3 more cities
- Recruiting
Interventions (9)
- Medication
VP16
60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning
- Radiation therapy
TBI
2 x 2Gy/day , 3 days (total 12Gy)
- Medication
Thiotepa
2x5 mg/kg BW, 1 day
- Medication
Treosulfan
14g/m² BS, 3 days
- Medication
Fludarabine
30 mg/m² BS, 5 days
- Medication
Busulfan
iV, dosage according therapeutic drug monitoring, 4 days
- Medication
ATG Thymoglobulin
MD: ATG Thymo: 2,5mg/kg BW/d 3 days.
- Medication
Cyclophosphamide
as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna
- Medication
Grafalon
MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days
Canadian Sites (6)
6 listed, none recruiting
- Not currently recruiting
Alberta Children's Hospital Division of Pediatric Oncology
Calgary
- Not currently recruiting
Montreal Children's Hospital
Montral
- Not currently recruiting
CHU Sainte-Justine Hematology-Oncology Division
Montreal
- Completed
Hospital for Sick Children University of Toronto Division of Haematology/Oncology
Toronto
- Completed
BC Children's Hospital
Vancouver
- Withdrawn
CancerCare Manitoba/University of Manitoba
Winnipeg
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
- +age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years
- +indication for allogeneic HSCT
- +complete remission (CR) before HSCT
- +written consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form"
- +no secondary malignancy
- +no previous HSCT
- +HSCT is performed in a study participating centre
- +no pregnancy
Exclusion
- −patients who do not fulfil the inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →
- −Non Hodgkin-Lymphoma
- −the whole protocolProtocolThe detailed plan a study must follow.Read more → or essential parts are declined either by patient himself/herself or the respective legal guardian
- −no consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
- −Karnofsky / Lansky score \< 50%
- −subjects unwilling or unable to comply with the study procedures
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A receives one or more of: Thiotepa, Treosulfan, Fludarabine, ATG Thymoglobulin and Grafalon.
Registry label: A: Flu/Thio/Treo
Group B, the comparison group, receives TBI and VP16, together with one or more of: ATG Thymoglobulin and Grafalon.
Registry label: B: TBI/VP16
Group C receives one or more of: Thiotepa, Fludarabine, Busulfan, ATG Thymoglobulin, Cyclophosphamide and Grafalon.
Registry label: C: Flu/Thio/ivBu
Group D receives VP16, together with one or more of: Busulfan and Cyclophosphamide.
Registry label: D: Bu/VP16/Cy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 1 month to 18 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,800 people.
The study is currently expected to finish around June 2030.
The main measurement is taken over: first: 18 months after inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → of first patient, afterwards annually up to 10 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Overall Survival (OS) Stratum 1a (randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → TBI+ chemo-conditioning vs. chemo-conditioning only) — measured over first: 18 months after inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → of first patient, afterwards annually up to 10 years.
Event free survival (EFS) Stratum 2 (mismatched donor transplantation) — measured over first: 18 months after inclusion of first patient, afterwards annually up to 10 years.
Overall Survival (OS), Stratum 1b: MSD/MD without randomisation — measured over first: 18 months after inclusion of first patient, afterwards annually up to 10 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT01949129 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About VP16Drug
60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TBIRadiation
2 x 2Gy/day , 3 days (total 12Gy)
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About ThiotepaDrug
2x5 mg/kg BW, 1 day
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TreosulfanDrug
14g/m² BS, 3 days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About FludarabineDrug
30 mg/m² BS, 5 days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About BusulfanDrug
iV, dosage according therapeutic drug monitoring, 4 days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About ATG ThymoglobulinDrug
MD: ATG Thymo: 2,5mg/kg BW/d 3 days.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CyclophosphamideDrug
as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GrafalonDrug
MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 1 month to 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 1 month to 18 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: first: 18 months after inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → of first patient, afterwards annually up to 10 years.
The study as a whole is currently expected to finish around 2030-06-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,800 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Calgary, Canada; Montral, Canada; Montreal, Canada; Toronto, Canada; Vancouver, Canada; Winnipeg, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.
If this study interests you
Three things you can do from here. None of them commits you to anything.
Save it to your Collection
Keep it with the other studies you are looking at.
Share it with your doctor
Send the study to your own clinician to talk through together.
Ask someone to help you approach it
Someone at Concord will read your request and email you. The study team decides who takes part.
Or answer a few questions to see which studies in Canada are closest to what you described.
This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.