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Lymphoblastic Leukemia, Acute, Childhood;Phase 3NCT01423747

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

A Phase 3 study testing VP16, TBI and VP16, ATG in people with Lymphoblastic Leukemia, Acute, Childhood;, run by St. Anna Kinderkrebsforschung at 24 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

With this protocol the ALL-SZT BFM international study group wants to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated matched donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). Read more about this study

Who is it for?
Ages 3 months to 18 years
What is being tested?
VP16, TBI and VP16, ATG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
24 sitesin 2 countries
Study dates
Jul 2003to Sep 2016
Phase
Phase 3
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 3 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18 years
  • indication for allogeneic hematopoietic stem cell transplantation (HSCT)
  • complete remission before hematopoietic stem cell transplantation (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 hematopoietic stem cell transplantation (HSCT)
  • hematopoietic stem cell transplantation (HSCT) is performed in a study participating centre.

Who cannot join

  • age at time of initial diagnosis or relapse diagnosis, respectively above 18 years
  • no indication for allogeneic HSCT
  • no complete remission before SCT
  • no written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
  • pregnancy
  • secondary malignancy
  • previous HSCT
  • HSCT is not performed in a study participating centre.

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

Germany21 sites

  • Charité Campus Virchow- Klinikum, Klinikum der Pädiatrie, Onkologie/Hämatologie/KMT

    Berlin, 13353

  • Klinik und Poliklinik für Kinderheilkunde, Hämatologie, Onkologie

    Dresden, 01307

  • Universitätsklinikum Düsseldorf, Klinik f. Kinderonkologie, Hämatologie u. Immunologie

    Düsseldorf, 40001

  • Klinik für Kinder und Jugendliche der Universität Erlangen-Nürnberg

    Erlangen, 91054

  • Universitätsklinikum Essen, Zentrum für Kinderheilkunde, Abt. für Hämatologie/Onkologie

    Essen, 45122

  • Klinik für Kinderheilkunde III, Hämatologie und Onkologie, Johann Wolfgang Goethe Universität

    Frankfurt am Main, 60590

  • Universitätsklinikum Freiburg, Zentrum für Kinderheilkunde und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie

    Freiburg im Breisgau, 79106

  • Zentrum für Kinderheilkunde, Abt. Hämatologie und Onkologie

    Giessen, 35385

  • Klinkum der Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg, Uni. Klinik un Poliklinik für Kinder- und Jugendmedizin

    Halle, 06097

  • Universitätsklinikum Hamburg-Eppendorf, Kinderklinik, Abt. für Hämatologie und Onkologie

    Hamburg, 20246

  • Med. Hochschule Hannover, Päd. Hämatologie und Onkologie

    Hanover, 30625

  • Universitätskinderklinik, Päd. Hämatologie, Onkologie und Immunologie

    Heidelberg, 69120

  • Klinik für Knochenmarktransplantation

    Idar-Oberstein, 55743

  • Klinik für Kinder- und Jugendmedizin

    Jena, 07724

  • Universitätsklinikum Kiel, Klinik für Allgemeine Pädiatrie

    Kiel, 24105

  • Klinikum der Universität München, Dr. von Haunersches Kinderspital, Abt. für Hämatologie / Onkologie

    München, 80337

  • Städt. Krankenhaus München-Schwabing, Universitätskinderklinik der TU

    München, 80804

  • Universitätsklinikum Münster, Klinik und Poliklinik für Kinderheilkunde, päd. Hämatologie / Onkologie

    Münster, 48149

  • Univ.-Klinik für Kinderheilkunde und Jugendmedizin

    Tübingen, 72076

  • Universitätskinderklinik

    Ulm, 89075

  • Universitätsklinik, päd. Onkologie/Stammzelltransplantation

    Würzburg, 97080

Other trials in Germany

Austria3 sites

  • Universitätsklinik für Kinder- und Jugendheilkunde, Klin. Abt. f. Hämato-Onkologie

    Graz, 8036

  • Universitätsklinik für Kinder- und Jugendheilkunde

    Innsbruck, 6020

  • St. Anna Kinderspital

    Vienna, 1090

Other trials in Austria

About this study

With this protocol the ALL-SZT BFM international study group wants

to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated matched donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).

Read more

to evaluate the efficacy of haematopoietic stem cell transplantation (HSCT) from mismatched family or unrelated mismatched donors (MMD) as compared to HSCT from matched sibling donor (MSD) and matched donor (MD).

to determine whether therapy has been carried out according to the main haematopoietic stem cell transplantation (HSCT) protocol recommendations. The standardisation of the treatment options during haematopoietic stem cell transplantation (HSCT) from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only.

to prospectively evaluate and compare the incidence of acute and chronic graft- versus-host-disease (GvHD) after haematopoietic stem cell transplantation (HSCT) from matched sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).

Read the detailed description

Patients with high risk or relapsed acute lymphoblastic leukaemia (ALL) have a worse prognosis compared to all other patients with ALL. For these patients additional therapy approaches are required after they have achieved remission with multimodal chemotherapy. Allogeneic haematopoetic stem cell transplantation shows promising results mainly due to an immunological antileukaemic control by the graft-versus-leukaemia effect, but treatment related mortality and morbidity remains a serious problem.

Being tested
VP16, TBI, VP16, ATG, Fludarabine, OKT3, Treosulfan, Thiotepa
Keywords
ALL, HSCT, children, adolescents
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VP16Drug

    Also called Etoposid

    patients with MSD receive as conditioning VP16 60mg/kg/d on day -3

  • TBIRadiation

    Also called total body irradiation

    patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning

  • VP16, ATGDrug

    Also called Etoposid, Antithymoglobuline

    patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1

  • TBIRadiation

    Also called total body irradiation

    patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)

  • Fludarabine, OKT3, Treosulfan, ThiotepaDrug

    Also called ATG:Antithymoglobuline

    patients with a MMD (haploidentical or cord blood) receive Fludarabine 30mg/m²/d on day -9 to -5, ATG 20mg/kd/d on day -3 to day -1, Treosulfan 14g/m²/d on day -7 to -5 and Thiotepa 2x5mg/kg/d on day -4

  • VP16, ATGDrug

    Also called Etoposid, Antithymoglobuline

    patients with MMD-transplantation (8/10)receive VP16 60mg/kg/d on day -4, ATG from day -3 to day-1 20mg/kg/d

  • TBIRadiation

    Also called total body irradiation

    patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions

Study groups in NCT01423747
Study groupRoleWhat they receive
MSD - matched sibling donorOtherpatients with a MSD receive a conditioning of total body irradiation (TBI) (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3)
Receives: Drug: VP16; Radiation: TBI
MD - matched donorOtherpatients with a HLA (Human Leukocyte Antigen) matched unrelated Donor (9/10 oder 10/10) receive total body irradiation (TBI) (12Gy in 6 fractions), VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
Receives: Drug: VP16, ATG; Radiation: TBI
MMD - mismatched DonorOtherPatients with a mismatched donor receive stem cells either from cord blood, a haploidentical donor (parent) or from a non-related donor with a match less or equal 8/10
Receives: Drug: Fludarabine, OKT3, Treosulfan, Thiotepa; Drug: VP16, ATG; Radiation: TBI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free and overall survival after allogeneic haematopoietic stem cell transplantation (HSCT)

    Measured: 14 years

Secondary outcomes (5)

  1. occurrence of acute and chronic Graft-versus-Host-Disease (GvHD)

    Evaluation of the incidence and severity of acute Grade I-IV Graft-versus-Host-Disease (GvHD) and of limited or extensive chronic GvHD

    Measured: 14 years

  2. occurrence and course of late effects after chemotherapy with subsequent allogeneic hematopoietic stem cell transplantation (HSCT)

    valuation of organ dysfunctions according to WHO Toxicity score

    Measured: 14 years

  3. occurrence and course of late effects after chemotherapy with subsequent allogeneic hematopoietic stem cell transplantation (HSCT)

    evaluation of growth retardation and endocrine dysfunction

    Measured: 14

  4. occurrence and course of late effects after chemotherapy with subsequent allogeneic hematopoietic stem cell transplantation (HSCT)

    Evaluation of incidence of aseptic bone necrosis

    Measured: 14 years

  5. occurrence and course of secondary malignancies after chemotherapy with subsequent allogeneic hematopoietic stem cell transplantation (HSCT)

    Evaluation of incidence of secondary cancer after total body irradiation (TBI) and/or chemotherapy

    Measured: 14 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2011 (estimated)
  2. Study startJul 2003
  3. Primary completionSep 2011
  4. Study completionSep 2016 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01423747
Sponsor's protocol ID
ALL-SZT- BFM 2003
Status last verified
Jun 2015
First submitted
25 Aug 2011
Last updated
26 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Peters C, Schrauder A, Schrappe M, von Stackelberg A, Stary J, Yaniv I, Gadner H, Klingebiel T; BFM Study Group, the IBFM-Study Group and the Paediatric Disease Working Party of the EBMT. Allogeneic haematopoietic stem cell transplantation in children with acute lymphoblastic leukaemia: the BFM/IBFM/EBMT concepts. Bone Marrow Transplant. 2005 Mar;35 Suppl 1:S9-11. doi: 10.1038/sj.bmt.1704835.

    PubMed 15812540

  • Pulsipher MA, Peters C, Pui CH. High-risk pediatric acute lymphoblastic leukemia: to transplant or not to transplant? Biol Blood Marrow Transplant. 2011 Jan;17(1 Suppl):S137-48. doi: 10.1016/j.bbmt.2010.10.005.

    PubMed 21195303

  • Peters C, Schrappe M, von Stackelberg A, Schrauder A, Bader P, Ebell W, Lang P, Sykora KW, Schrum J, Kremens B, Ehlert K, Albert MH, Meisel R, Matthes-Martin S, Gungor T, Holter W, Strahm B, Gruhn B, Schulz A, Woessmann W, Poetschger U, Zimmermann M, Klingebiel T. Stem-cell transplantation in children with acute lymphoblastic leukemia: A prospective international multicenter trial comparing sibling donors with matched unrelated donors-The ALL-SCT-BFM-2003 trial. J Clin Oncol. 2015 Apr 10;33(11):1265-74. doi: 10.1200/JCO.2014.58.9747. Epub 2015 Mar 9.

    PubMed 25753432

  • Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.

    PubMed 33242441

  • Preuner S, Peters C, Potschger U, Daxberger H, Fritsch G, Geyeregger R, Schrauder A, von Stackelberg A, Schrappe M, Bader P, Ebell W, Eckert C, Lang P, Sykora KW, Schrum J, Kremens B, Ehlert K, Albert MH, Meisel R, Lawitschka A, Mann G, Panzer-Grumayer R, Gungor T, Holter W, Strahm B, Gruhn B, Schulz A, Woessmann W, Lion T. Risk assessment of relapse by lineage-specific monitoring of chimerism in children undergoing allogeneic stem cell transplantation for acute lymphoblastic leukemia. Haematologica. 2016 Jun;101(6):741-6. doi: 10.3324/haematol.2015.135137. Epub 2016 Feb 11.

    PubMed 26869631

  • Bader P, Kreyenberg H, von Stackelberg A, Eckert C, Salzmann-Manrique E, Meisel R, Poetschger U, Stachel D, Schrappe M, Alten J, Schrauder A, Schulz A, Lang P, Muller I, Albert MH, Willasch AM, Klingebiel TE, Peters C. Monitoring of minimal residual disease after allogeneic stem-cell transplantation in relapsed childhood acute lymphoblastic leukemia allows for the identification of impending relapse: results of the ALL-BFM-SCT 2003 trial. J Clin Oncol. 2015 Apr 10;33(11):1275-84. doi: 10.1200/JCO.2014.58.4631. Epub 2015 Jan 20.

    PubMed 25605857

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VP16, TBI and VP16, ATG in people with Lymphoblastic Leukemia, Acute, Childhood;, run by St. Anna Kinderkrebsforschung at 24 sites in 2 countries.

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 8 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 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany, Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free and overall survival after allogeneic haematopoietic stem cell transplantation (HSCT) (time frame: 14 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01423747, which also lists 6 linked publications.

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 26 Jun 2015.

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