Acute Lymphoblastic LeukemiaPhase 4NCT02670564
ALL SCTped FORUM - Pharmacogenomic Study (add-on Study)
A Phase 4 study testing Pharmacogenomics and Busulfan plasma level measurements in people with Acute Lymphoblastic Leukemia, run by Swiss Pediatric Oncology Group at 4 sites in Switzerland.
Trial summary
Pharmacogenomics (PG) offers the opportunity to individualize treatment according to patient genetic variations which influence activity of enzyme metabolizing or acting in the pathway of prescribed chemotherapy drugs. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Pharmacogenomics and Busulfan plasma level measurements
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesSwitzerland
- Study dates
- Apr 2013to Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites, 4 recruiting
- Recruiting
Universitäts-Kinderspital beider Basel (UKBB), Onkologie/Hämatologie
Basel, 4056
Nicolas Von der Weid, + 41 61 704 12 12, nicolas.vonderweid@ukbb.ch
- Recruiting
Hôpital Cantonal de Genève, Département de Pédiatrie
Geneva, Cansearch Laboratory, 1211
Marc Ansari, MD, PD, +41 22 382 47 31, Marc.Ansari@hcuge.ch
- Recruiting
HUG Hôpitaux Universitaire de Genève, Unité d'onco-hématologie pédiatrique
Geneva, 1211
Marc Ansari, +41 22 372 47 31, Marc.Ansari@hcuge.ch
- Recruiting
Universitäts-Kinderspital
Zurich, 8032
Güngör Tayfun, +41 44 266 74 92, tayfun.guengoer@kispi.uzh.ch
About this study
Official title: Allogeneic Stem Cell Transplant for Children and Adolescents With Acute Lymoblastic Leukemia FORUM - Pharmacogenomic Study (add-on Study)
Pharmacogenomics (PG) offers the opportunity to individualize treatment according to patient genetic variations which influence activity of enzyme metabolizing or acting in the pathway of prescribed chemotherapy drugs.
This add-on research aims to prospectively investigate variations in several candidate genes related to all types of chemotherapeutic drugs and TBI used in the main related study NCT 01949129, THE ALL SCTped FORUM study for their potential role as predictive biomarkers of PK variability and outcome of myeloablative therapy for pediatric patients receiving an allogeneic hematopoietic stem cell transplantation in acute lymphoblastic leukemia.
Read the detailed description
Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.
Busulfan (Bu) is a key compound in conditioning myeloablative regimens for patients undergoing hematopoietic stem cell transplantation (HSCT). Bu has been long used for the treatment of patients with leukemia and some congenital disorders; advantages and disadvantages of such treatment are well described. However, although Bu treatment has been shown to be effective, its use may be limited by related adverse events such as veno-occlusive disease (VOD), interstitial pneumonitis, acute Graft vs Host Disease (GVHD), and seizures. Thus, novel therapies are being investigated as well as the pharmacogenetics of these drugs. One of alternative drugs that may replace Bu due to its lower toxicity profile is Treosulfan (Treo). Fludarabine (Flu) is usually used in combination with Bu or Treo as an alternative to cyclophosphamide (Cy) also due to its lower toxicity. Thus, the Bu/Flu regimen is now being used more often than the previously more common Bu/Cy regimen. However, improvement to the regimen is still needed for reducing adverse drug effects. Pharmacogenomics (PG) offers the opportunity to individualize treatment according to patient genetic variations which influence activity of enzyme metabolizing or acting in the pathway of prescribed chemotherapy drugs.
This add-on research aims to prospectively investigate variations in several candidate genes (e.g GST, DCK and DNA repair pathway genes) related to all types of chemotherapeutic drugs (Bu/Flu/Thio; Treo/Flu/Thio and TBI/VP16) used in this protocol for their potential role as predictive biomarkers of pharmacokinetics (PK) variability and outcome of myeloablative therapy for pediatric patients receiving an allogeneic HSCT in acute lymphoblastic leukemia
For the busulfan arm countries: a cross-validation of busulfan quantification is performed. All Bu Therapeutic Drug Monitoring participating at the main ALL SCTped FORUM study will be assessed for the accuracy (%) and trueness (%) of 8 blinded Bu Quality Control samples. Criteria of acceptance are set according to FDA and ICH guidelines.
Blood samples will be collected prior to initiation of therapy for DNA banking and DNA analysis (for all patients), for DNA analysis (TBI/VP16, Bu/Flu/Thiotepa and Treo/Flu/Thiotepa groups) and PK analysis (only for the Bu group). PK and pharmacogenomic data will then be correlated with the studied outcomes (e.g.Veno-occlusive disease, Graft vs host disease, Treatment Related Mortality, Events Free Survival, Overall Survival).
Recruitment:
Patients (children) age 0-18 will be recruited in each arm. No oral Bu is allowed in this study.
Shipment (when there is a minimum of 10 patients) Send all the materials listed to: Dr Marc Ansari, Plateforme d'Hématologie et Oncologie Pédiatrique (CANSEARCH research laboratory), Faculté de Médecine, Bâtiment Tulipe, 5th floor, Av De La Roseraie 64, GENEVE 1205 Switzerland.
Contact Dr. Ansari's laboratory prior to shipment: Phone (+41 79 55 36 100) and e-mail (research@cansearch.ch). All shipments must be sent frozen by a carrier guaranteeing overnight delivery with the indication "Pharmacogenomic study" on the face of the parcel.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Pharmacogenomics, Busulfan plasma level measurements
- Keywords
- pharmacogenetics, busulfan, treosulfan, hematopoietic stem cell transplantation, fludarabine, pediatric patients, TBI, leukemia, leukemia, lymphoid, precursor cell lymphoblastic Leukemia-Lymphoma, Immune System disease, Immunoproliferative Disorders, stem cell transplantation, children and adolescent, high risk acute lymphoblastic leukemia, NCT01949129 add-on, ALL SCTped FORUM
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Leukemia, Lymphoid, Immune System Diseases, Immunoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacogenomicsGenetic
Also called DNA analyses
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.
Busulfan plasma level measurementsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Total body irradiation (TBI) | Experimental | 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. Receives: Genetic: Pharmacogenomics |
| Busulfan | Experimental | 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. Receives: Genetic: Pharmacogenomics; Other: Busulfan plasma level measurements |
| Treosulfan | Experimental | 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. Receives: Genetic: Pharmacogenomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic variants in participants as a marker of risk of Adverse events and/or Efficacy of the studied agents
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).
Measured: through study completion, an average of 2 years
Secondary outcomes (10)
Number of participants with acute Graft-versus-host disease (aGvHD) according to the Glucksberg scale and Seattle criteria
Measured: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Number of participants with chronic Graft-versus-host disease (cGvHD) according to the Glucksberg scale and Seattle criteria
Measured: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Number of participants with VOD/SOS according to the Seattle criteria
Measured: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Number of participants with Neutrophil recovery as a measure of Safety and Tolerability
defined as the first of 3 consecutive days with an absolute neutrophil count of 0.5x10^9/L or higher
Measured: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Number of participants with Platelet recovery as a measure of Safety and Tolerability
Defined as the first of 3 consecutive days with platelet counts higher that 20x10^9/L without transfusion
Measured: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Number of participants with Primary graft failure or rejection as a measure of Safety and Tolerability
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
Measured: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Transplant related mortality (TRM)
the time of transplant until all causes of death after transplant not related to relapse
Measured: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Event free survival (EFS)
the time of transplant until death, relapse or graft failure, whichever occurs first.
Measured: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Overall survival (OS)
the time between transplantation and death due to any causes
Measured: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Cumulative incidence of relapse
Measured: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startApr 2013
- Primary completionApr 2021 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Pediatric Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- ALL SCTped Forum
- Responsible party
- Sponsor
- Investigators
- Christina Peters, Prof. MD PhD, Study chair, St. Anna Kinderspital, Vienna, AustriaPeter Bader, Prof. MD PhD, Study chair, Klinik für Kinder- u. Jugendheilkunde III, Johann Wolfgang Goethe Universität, Frankfurt, GermanyFranco Locatelli, Prof. MD PhD, Study chair, Department of Pediatric Hematology and Oncology IRCCS Ospedale, Rome, ItalyMarc Ansari, MD, PD, Principal investigator, Département de Pédiatrie, Hôpital Cantonal de Genève
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670564
- Sponsor's protocol ID
- ZH 2014-0535
- Other IDs
- NZ 2015-069, GE 15-034
- Status last verified
- Apr 2019
- First submitted
- 3 Jul 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplant for Children and Adolescents With Acute Lymoblastic Leukemia FORUM - Pharmacogenomic Study (add-on Study)
- ClinicalTrials.gov ID
- NCT02670564
- Acronym / sponsor ID
- ZH 2014-0535
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- pharmacogenetics, busulfan, treosulfan, hematopoietic stem cell transplantation, fludarabine, pediatric patients, TBI, leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Swiss Pediatric Oncology GroupUniversity, hospital or other
- Collaborators
- ALL SCTped Forum
- Study start
- Apr 2013
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacogenomics (PG) offers the opportunity to individualize treatment according to patient genetic variations which influence activity of enzyme metabolizing or acting in the pathway of prescribed chemotherapy drugs.
This add-on research aims to prospectively investigate variations in several candidate genes related to all types of chemotherapeutic drugs and TBI used in the main related study NCT 01949129, THE ALL SCTped FORUM study for their potential role as predictive biomarkers of PK variability and outcome of myeloablative therapy for pediatric patients receiving an allogeneic hematopoietic stem cell transplantation in acute lymphoblastic leukemia.
Detailed description
Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.
Busulfan (Bu) is a key compound in conditioning myeloablative regimens for patients undergoing hematopoietic stem cell transplantation (HSCT). Bu has been long used for the treatment of patients with leukemia and some congenital disorders; advantages and disadvantages of such treatment are well described. However, although Bu treatment has been shown to be effective, its use may be limited by related adverse events such as veno-occlusive disease (VOD), interstitial pneumonitis, acute Graft vs Host Disease (GVHD), and seizures. Thus, novel therapies are being investigated as well as the pharmacogenetics of these drugs. One of alternative drugs that may replace Bu due to its lower toxicity profile is Treosulfan (Treo). Fludarabine (Flu) is usually used in combination with Bu or Treo as an alternative to cyclophosphamide (Cy) also due to its lower toxicity. Thus, the Bu/Flu regimen is now being used more often than the previously more common Bu/Cy regimen. However, improvement to the regimen is still needed for reducing adverse drug effects. Pharmacogenomics (PG) offers the opportunity to individualize treatment according to patient genetic variations which influence activity of enzyme metabolizing or acting in the pathway of prescribed chemotherapy drugs.
This add-on research aims to prospectively investigate variations in several candidate genes (e.g GST, DCK and DNA repair pathway genes) related to all types of chemotherapeutic drugs (Bu/Flu/Thio; Treo/Flu/Thio and TBI/VP16) used in this protocol for their potential role as predictive biomarkers of pharmacokinetics (PK) variability and outcome of myeloablative therapy for pediatric patients receiving an allogeneic HSCT in acute lymphoblastic leukemia
For the busulfan arm countries: a cross-validation of busulfan quantification is performed. All Bu Therapeutic Drug Monitoring participating at the main ALL SCTped FORUM study will be assessed for the accuracy (%) and trueness (%) of 8 blinded Bu Quality Control samples. Criteria of acceptance are set according to FDA and ICH guidelines.
Blood samples will be collected prior to initiation of therapy for DNA banking and DNA analysis (for all patients), for DNA analysis (TBI/VP16, Bu/Flu/Thiotepa and Treo/Flu/Thiotepa groups) and PK analysis (only for the Bu group). PK and pharmacogenomic data will then be correlated with the studied outcomes (e.g.Veno-occlusive disease, Graft vs host disease, Treatment Related Mortality, Events Free Survival, Overall Survival).
Recruitment:
Patients (children) age 0-18 will be recruited in each arm. No oral Bu is allowed in this study.
Shipment (when there is a minimum of 10 patients) Send all the materials listed to: Dr Marc Ansari, Plateforme d'Hématologie et Oncologie Pédiatrique (CANSEARCH research laboratory), Faculté de Médecine, Bâtiment Tulipe, 5th floor, Av De La Roseraie 64, GENEVE 1205 Switzerland.
Contact Dr. Ansari's laboratory prior to shipment: Phone (+41 79 55 36 100) and e-mail (research@cansearch.ch). All shipments must be sent frozen by a carrier guaranteeing overnight delivery with the indication "Pharmacogenomic study" on the face of the parcel.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total body irradiation (TBI) | Experimental | Genetic: PharmacogenomicsThe 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. |
| Busulfan | Experimental | Genetic: Pharmacogenomics, Other: Busulfan plasma level measurementsThe 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. |
| Treosulfan | Experimental | Genetic: PharmacogenomicsThe 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmacogenomicsAlso: DNA analysesBlood 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. | Genetic | Busulfan, Total body irradiation (TBI), Treosulfan |
| Busulfan plasma level measurementsBu 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 | Other | Busulfan |
Primary outcome
Genetic variants in participants as a marker of risk of Adverse events and/or Efficacy of the studied agents
Time frame: through study completion, an average of 2 years
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).
10 secondary outcomes
Number of participants with acute Graft-versus-host disease (aGvHD) according to the Glucksberg scale and Seattle criteria
Time frame: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Number of participants with chronic Graft-versus-host disease (cGvHD) according to the Glucksberg scale and Seattle criteria
Time frame: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Number of participants with VOD/SOS according to the Seattle criteria
Time frame: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Number of participants with Neutrophil recovery as a measure of Safety and Tolerability
Time frame: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Number of participants with Platelet recovery as a measure of Safety and Tolerability
Time frame: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Number of participants with Primary graft failure or rejection as a measure of Safety and Tolerability
Time frame: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Transplant related mortality (TRM)
Time frame: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Event free survival (EFS)
Time frame: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Overall survival (OS)
Time frame: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Cumulative incidence of relapse
Time frame: 18 months after inclusion of first patient, afterwards, annually up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Cansearch laboratoryLink provided by the sponsor.
- St. Anna KinderkrebsforschungLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Peters, Prof. MD PhD study chair
St. Anna Kinderspital, Vienna, Austria
Peter Bader, Prof. MD PhD study chair
Klinik für Kinder- u. Jugendheilkunde III, Johann Wolfgang Goethe Universität, Frankfurt, Germany
Franco Locatelli, Prof. MD PhD study chair
Department of Pediatric Hematology and Oncology IRCCS Ospedale, Rome, Italy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pharmacogenomics and Busulfan plasma level measurements in people with Acute Lymphoblastic Leukemia, run by Swiss Pediatric Oncology Group at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Ansari, MD, PD (+41 22 382 47 31 ext. +41 79 502 338, Marc.Ansari@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic variants in participants as a marker of risk of Adverse events and/or Efficacy of the studied agents (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.