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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

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

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 below

Exclusion 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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Acute Coryza

EFS (Stratum 1a and 1b)

OS (Stratum 2)

+2 more

Other study objectives

Acute Graft versus Host Disease (aGVHD)

Chronic Graft-versus-host disease (cGvHD)

Secondary malignancies

Awards & Highlights

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.

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