Health Trials

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

ConditionAcute Lymphoblastic Leukaemia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSt. Anna Kinderkrebsforschung

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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"

Disqualifiers

patients who do not fulfil the inclusion criteria

Non Hodgkin-Lymphoma

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • VP16

    Drug

    60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning

  • TBI

    Radiation

    2 x 2Gy/day , 3 days (total 12Gy)

  • Thiotepa

    Drug

    2x5 mg/kg BW, 1 day

  • Treosulfan

    Drug

    14g/m² BS, 3 days

  • Fludarabine

    Drug

    30 mg/m² BS, 5 days

  • Busulfan

    Drug

    iV, dosage according therapeutic drug monitoring, 4 days

  • ATG Thymoglobulin

    Drug

    MD: ATG Thymo: 2,5mg/kg BW/d 3 days.

  • Cyclophosphamide

    Drug

    as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna

  • Grafalon

    Drug

    MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days

Treatment groups

1,800 Participants
are divided into 4 treatment groups
Group A: Flu/Thio/TreoExperimental treatment 5 interventions
Group B: TBI/VP16Active comparator 4 interventions
Group C: Flu/Thio/ivBuExperimental treatment 6 interventions
Group D: Bu/VP16/CyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only)

Stratum 1 - randomisation related question was closed in December 2018; patients are in active follow-up: To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD). The primary endpoint is the OS calculated from the date of the randomisation. Death from any cause will be considered an event.

Time frame
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
2

Event free survival (EFS) Stratum 2 (mismatched donor transplantation)

EFS after allogeneic HSCT. EFS calculated from date of recruitment to disease progression or relapse, secondary neoplasm and death from any cause.

Time frame
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
3

Overall Survival (OS), Stratum 1b: MSD/MD without randomisation

To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire MSD/MD cohort

Time frame
first: 18 months after inclusion of first patient, afterwards annually up to 10 years

Secondary outcomes

1

EFS (Stratum 1a and 1b)

EFS calculated from date of randomization (1a) or recruitment (1b) to disease progression or relapse, secondary neoplasm and death from any cause. Patients lost to follow-up without event will be censored at the date of their last follow-up evaluation.

Time frame
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
2

TRM

Cumulative Incidence of Treatment-related mortality (TRM) for Stratum 1 and 2.

Time frame
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
3

Relapse/progression

Cumulative Incidence of Relapse for Stratum 1a, 1b and 2.

Time frame
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
4

Acute and late toxicity for Stratum 1a, 1b and 2

according a preselection out of CTC3

Time frame
first: 18 months after inclusion of first patient, afterwards annually up to 10 years

Other outcomes

1

Acute Graft versus Host Disease (aGVHD)

According to the modified Seattle Glucksberg criteria

Time frame
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
2

Secondary malignancies

Incidence, type and timepoint of occurence

Time frame
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
3

Chronic Graft-versus-host disease (cGvHD)

Chronic GVHD is diagnosed using criteria created through the NIH consensus development project

Time frame
first: 18 months after inclusion of first patient, afterwards annually up to 10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Anna Kinderkrebsforschung

Lead sponsor

ALL SCTped Forum

Collaborator

European Society for Blood and Marrow Transplantation

Collaborator

ALL-BFM Study Group

Collaborator

Assistance Publique - Hôpitaux de Paris

Collaborator

Dutch Childhood Oncology Group

Collaborator

Swiss Pediatric Oncology Group

Collaborator

Australian & New Zealand Children's Haematology/Oncology Group

Collaborator

Source ClinicalTrials.gov
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