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Immunosuppressant
Stem Cell Transplant for Acute Lymphoblastic Leukemia
Phase 2 & 3
Recruiting
Research Sponsored by St. Anna Kinderkrebsforschung
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with ALL (except for patients with B-ALL) who fulfill the following criteria: age at diagnosis ≤ 18 years, Age at HSCT ≤ 21 years, 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
Be younger than 65 years old
Must not have
Karnofsky / Lansky score < 50%
The whole protocol or essential parts are declined either by the patient himself/herself or the respective legal guardian
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Awards & highlights
Summary
This trial is for children and adolescents with ALL who are in complete morphological remission and need a myeloablative conditioning regimen for HSCT. The patients are stratified according to the transplantation modalities available to them.
Who is the study for?
This trial is for children and adolescents up to 21 years old with Acute Lymphoblastic Leukemia in complete remission, who need a stem cell transplant. They must not be pregnant, have had previous transplants, or suffer from severe diseases that could interfere with the treatment.
What is being tested?
The study tests how well different myeloablative conditioning regimens work before a stem cell transplant. These include drugs like Fludarabine and Cyclophosphamide, as well as procedures such as Total Body Irradiation (TBI).
What are the potential side effects?
Possible side effects may include damage to bone marrow, increased risk of infections due to immune suppression, organ toxicity (heart, liver), gastrointestinal problems (nausea/vomiting), and potential infertility.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need considerable assistance and medical care.
Select...
I, or my legal guardian, have not refused any part of the treatment plan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event free survival (EFS) Stratum 2 (mismatched donor transplantation)
Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only)
Overall Survival (OS), Stratum 1b: MSD/MD without randomisation
Secondary outcome measures
Acute Coryza
EFS (Stratum 1a and 1b)
OS (Stratum 2)
+2 moreOther outcome measures
Acute Graft versus Host Disease (aGVHD)
Chronic Graft-versus-host disease (cGvHD)
Secondary malignancies
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Flu/Thio/ivBuExperimental Treatment6 Interventions
Fludarabine/Thiotepa/iV Busulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with:
* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
Group II: Flu/Thio/TreoExperimental Treatment5 Interventions
Fludarabine/Thiotepa/Treosulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with:
* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
Group III: Bu/VP16/CyExperimental Treatment3 Interventions
Busulfan/VP16/Cyclophosphamide is an alternative conditioning arm that may optionally be used for HSCT with MSD/MD and MMD graft in patients aged 0-24 months. Patients undergoing MD HSCT will also receive ATG Thymo- or Grafalon.
Group IV: TBI/VP16Active Control4 Interventions
TBI (Total Body Irradiation) / VP16 is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients older than 48 months with:
* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide.
Patients aged 24-48 months may optionally receive Total Body Irradiation (TBI).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
FDA approved
Cyclophosphamide
FDA approved
Treosulfan
FDA approved
Fludarabine
FDA approved
Etoposide
FDA approved
Thiotepa
FDA approved
Find a Location
Who is running the clinical trial?
Swiss Pediatric Oncology GroupOTHER
6 Previous Clinical Trials
5,610 Total Patients Enrolled
Australian & New Zealand Children's Haematology/Oncology GroupOTHER
6 Previous Clinical Trials
5,107 Total Patients Enrolled
Dutch Childhood Oncology GroupOTHER
7 Previous Clinical Trials
2,741 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Non-Hodgkin Lymphoma.I need considerable assistance and medical care.I am willing and able to follow the study's procedures.I, or my legal guardian, have not refused any part of the treatment plan.
Research Study Groups:
This trial has the following groups:- Group 1: TBI/VP16
- Group 2: Bu/VP16/Cy
- Group 3: Flu/Thio/ivBu
- Group 4: Flu/Thio/Treo
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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