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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first: 18 months after inclusion of first patient, afterwards annually up to 10 years

Awards & highlights

Study 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.Check my eligibility

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).See study design

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 below

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and first: 18 months after inclusion of first patient, afterwards annually up to 10 years for reporting.

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 more

Other 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

Treosulfan

FDA approved

Fludarabine

FDA approved

Busulfan

FDA approved

Cyclophosphamide

FDA approved

Etoposide

FDA approved

Thiotepa

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dutch Childhood Oncology GroupOTHER

7 Previous Clinical Trials

2,741 Total Patients Enrolled

Australian & New Zealand Children's Haematology/Oncology GroupOTHER

6 Previous Clinical Trials

5,107 Total Patients Enrolled

Swiss Pediatric Oncology GroupOTHER

6 Previous Clinical Trials

5,610 Total Patients Enrolled

Media Library

ATG Thymoglobulin (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT01949129 — Phase 2 & 3

Acute Lymphoblastic Leukemia Research Study Groups: TBI/VP16, Bu/VP16/Cy, Flu/Thio/ivBu, Flu/Thio/Treo

Acute Lymphoblastic Leukemia Clinical Trial 2023: ATG Thymoglobulin Highlights & Side Effects. Trial Name: NCT01949129 — Phase 2 & 3

ATG Thymoglobulin (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01949129 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a small or large-scale clinical trial?

"At the moment, there are six hospitals running this clinical trial. They are situated in cities such as Toronto, Montral and Vancouver. If you decide to participate in this trial, it would be best to choose a location near you to cut down on travel costs and time."

Answered by AI

What are some of the common illnesses that Cyclophosphamide has been used to target?

"While most often used to treat merkel cell cancer, cyclophosphamide has also been found to be helpful in managing leukemia, prostate cancer, and some forms of lung cancer."

Answered by AI

Does this research project welcome senior citizens as participants?

"Children aged 1 month to 18 years old can qualify for this clinical trial, as 855 other medical trials have done. In contrast, there are 2093 medical trials that use patients aged 65 and older."

Answered by AI

Who meets the screening criteria for this research project?

"This study is looking for 1000 individuals that have been diagnosed with leukemia or lymphoid at 1 month old or younger and are currently 18 years old or younger. The most crucial requirements for applicants are that they meet the following age criteria: age at diagnosis ≤ 18 years and age at HSCT ≤ 21 years. Additionally, applicants cannot be pregnant, have a secondary malignancy, or have had a previous HSCT."

Answered by AI

Are participants still being accepted for this clinical trial?

"This study is still recruiting patients, with the clinical trial having been originally posted on 2013-04-01 and updated as recently as 2020-09-29 according to clinicaltrials.gov."

Answered by AI

What is the purpose of this clinical research?

"The primary objective of this trial is to assess overall survival in patients who receive either standard chemotherapy or chemo-conditioning with TBI. The trial will follow patients for 18 months after inclusion of the first patient, and then annually for up to 10 years. Secondary objectives include assessment of treatment-related mortality, event-free survival, secondary neoplasms, and death from any cause. Patients lost to follow-up will be censored at the date of their last follow-up evaluation."

Answered by AI

Is Cyclophosphamide a common medication in research trials?

"There are 1141 ongoing studies involving Cyclophosphamide with 219 in Phase 3. Most of the research is being conducted in Philadelphia, but there are 36931 locations running trials for this medication."

Answered by AI

How many individuals are enrolled in this experiment?

"That is correct, the clinicaltrials.gov website states that this trial is still recruiting patients. This trial was first posted on April 1st, 2013 and was last updated on September 29th, 2020. They are looking for 1000 patients total, which will be recruited from 6 different locations."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Total Body Irradiation or Chemotherapy Conditioning in Childhood ALL: A Multinational, Randomized, Noninferiority Phase III Study

Peters, Christina, Jean-Hugues Dalle, Franco Locatelli, Ulrike Poetschger, Petr Sedlacek, Jochen Buechner, Peter J. Shaw, et al.. 2021. “Total Body Irradiation or Chemotherapy Conditioning in Childhood ALL: A Multinational, Randomized, Noninferiority Phase III Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.02529.

The Lancet HaematologyJournal

Targeted Therapy or Transplantation for Paediatric Abl-class Ph-like Acute Lymphocytic Leukaemia?

Tasian, Sarah K, and Christina Peters. 2020. “Targeted Therapy or Transplantation for Paediatric Abl-class Ph-like Acute Lymphocytic Leukaemia?”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(20)30369-0.

Therapeutic Drug MonitoringJournal

Therapeutic Drug Monitoring of Busulfan for the Management of Pediatric Patients: Cross-validation of Methods and Long-term Performance

Eva, Choong, Uppugunduri Chakradhara Rao Satyanarayana, Marino Denis, Kuntzinger Melanie, Doffey-Lazeyras Fabienne, Lo Piccolo Rodolfo, Chalandon Yves, Peters Christina, Daali Youssef, and Ansari Marc. 2018. “Therapeutic Drug Monitoring of Busulfan for the Management of Pediatric Patients: Cross-validation of Methods and Long-term Performance”. Therapeutic Drug Monitoring. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ftd.0000000000000468.

Journal of Pediatric Hematology/OncologyJournal