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Can a Chemo-Only prep beat radiation for childhood leukemia transplants?

NCT ID NCT01949129

Cure Sponsor: St. Anna Kinderkrebsforschung Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests different ways to prepare children and adolescents with acute lymphoblastic leukemia for a stem cell transplant. The goal is to see whether a conditioning regimen without total body irradiation works as well as one with it, and to find the best approach for different donor types. Participants receive either radiation plus chemotherapy or chemotherapy alone before the transplant. The study tracks survival and relapse to determine which approach offers the best chance for a cure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Allogeneic stem cell transplantation with various conditioning regimens (chemotherapy and/or radiation)
What this could lead to
If successful, this could identify the best way to prepare children for a stem cell transplant, potentially curing more cases of acute lymphoblastic leukemia.
What could go wrong
The trial is large and includes different donor types, so results may vary. Conditioning regimens carry risks like infections and organ damage, and the transplant may not prevent relapse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 1,800 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Apr 2013

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients with ALL (except for patients with B-ALL) who fulfil 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 Exclusion Criteria: * 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 * severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders) * Karnofsky / Lansky score \< 50% * subjects unwilling or unable to comply with the study procedures

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia adult acute lymphoblastic leukemia childhood acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukaemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites in 19 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O. San Gerardo di Monza Clinica Pediatrica

    ACTIVE_NOT_RECRUITING

    Monza, 20900, Italy

  • A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia

    WITHDRAWN

    Naples, 80123, Italy

  • Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit

    ACTIVE_NOT_RECRUITING

    Istanbul, Turkey (Türkiye)

  • Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit

    ACTIVE_NOT_RECRUITING

    Antalya, Turkey (Türkiye)

  • Alberta Children's Hospital Division of Pediatric Oncology

    ACTIVE_NOT_RECRUITING

    Calgary, Canada

  • Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit

    ACTIVE_NOT_RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Azienda Ospedaliera di Padova Oncoematologia Pediatrica

    WITHDRAWN

    Padova, 35128, Italy

  • Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O.

    WITHDRAWN

    Pisa, 56126, Italy

  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna

    WITHDRAWN

    Bologna, 40138, Italy

  • BC Children's Hospital

    COMPLETED

    Vancouver, Canada

  • Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit

    ACTIVE_NOT_RECRUITING

    Istanbul, Turkey (Türkiye)

  • Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit

    ACTIVE_NOT_RECRUITING

    Antalya, Turkey (Türkiye)

  • Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit

    ACTIVE_NOT_RECRUITING

    Istanbul, Turkey (Türkiye)

  • Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

    ACTIVE_NOT_RECRUITING

    Minsk, Belarus

  • CHRU Lille, Service d'Hématologie Pédiatrique

    ACTIVE_NOT_RECRUITING

    Lille, 59037, France

  • CHU Bordeaux

    ACTIVE_NOT_RECRUITING

    Bordeaux, 33076, France

  • CHU Clermont-Ferrand

    ACTIVE_NOT_RECRUITING

    Clermont-Ferrand, 63003, France

  • CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant

    ACTIVE_NOT_RECRUITING

    Grenoble, 38043, France

  • CHU Nancy - Hopital d'Enfants

    ACTIVE_NOT_RECRUITING

    Nancy, 54500, France

  • CHU Nantes, Service d'onco hémato pédiatrie

    ACTIVE_NOT_RECRUITING

    Nantes, 44093, France

  • CHU Sainte-Justine Hematology-Oncology Division

    ACTIVE_NOT_RECRUITING

    Montreal, Canada

  • CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique

    ACTIVE_NOT_RECRUITING

    Strasbourg, 67098, France

  • CHU de Rennes, Serive d'Onco-Pédiatrie

    ACTIVE_NOT_RECRUITING

    Rennes, 35203, France

  • CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique

    ACTIVE_NOT_RECRUITING

    Rouen, 76031, France

  • CancerCare Manitoba/University of Manitoba

    WITHDRAWN

    Winnipeg, Canada

  • Cape of Hope, Wroclaw Medical University

    ACTIVE_NOT_RECRUITING

    Wroclaw, Poland

  • Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman

    RECRUITING

    Liège, Belgium

  • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

    ACTIVE_NOT_RECRUITING

    Berlin, 13353, Germany

  • Children's Cancer Centre The Royal Children's Hospital

    ACTIVE_NOT_RECRUITING

    Melbourne, 3052, Australia

  • Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology

    ACTIVE_NOT_RECRUITING

    Lublin, Poland

  • Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique

    RECRUITING

    Brussels, 1200, Belgium

  • Dana Children's Hospital

    ACTIVE_NOT_RECRUITING

    Tel Aviv, 64239, Israel

  • Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University

    RECRUITING

    Prague, 150 06, Czechia

  • Department of Pediatrics, UHC Zagreb

    RECRUITING

    Zagreb, Croatia

  • Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki

    COMPLETED

    Helsinki, 00029 HUS, Finland

  • Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit

    ACTIVE_NOT_RECRUITING

    Izmir, Turkey (Türkiye)

  • Ege University School of Medicine Pediatric Stem Cell Transplantation Unit

    ACTIVE_NOT_RECRUITING

    Izmir, Turkey (Türkiye)

  • Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit

    ACTIVE_NOT_RECRUITING

    Kayseri, Turkey (Türkiye)

  • Fondazione IRCCS Policlinico San Matteo

    ACTIVE_NOT_RECRUITING

    Pavia, 27100, Italy

  • Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit

    ACTIVE_NOT_RECRUITING

    Ankara, Turkey (Türkiye)

  • Gülhane Training and Research Hospital

    ACTIVE_NOT_RECRUITING

    Ankara, Turkey (Türkiye)

  • HUG Hôpitaux Universitaire de Genève

    RECRUITING

    Geneva, 1211, Switzerland

  • Hopital Arnaud de Villeneuve

    ACTIVE_NOT_RECRUITING

    Montpellier, 34295, France

  • Hopital la Timone Adulte

    ACTIVE_NOT_RECRUITING

    Marseille, 13385, France

  • Hospital Dr Luis Calvo Mackenna

    RECRUITING

    Santiago, Chile

  • Hospital Materno Infantil de Málaga

    WITHDRAWN

    Málaga, Spain

  • Hospital Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Spain

  • Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit

    RECRUITING

    La Plata, 1651, Argentina

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, Spain

  • Hospital Vall d'Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Virgen de la Arrixaca

    RECRUITING

    Murcia, Spain

  • Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA

    RECRUITING

    Buenos Aires, Argentina

  • Hospital for Sick Children University of Toronto Division of Haematology/Oncology

    COMPLETED

    Toronto, Canada

  • Hôpital Robert Debré

    ACTIVE_NOT_RECRUITING

    Paris, 75019, France

  • Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

    RECRUITING

    Brussels, 1020, Belgium

  • IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique

    ACTIVE_NOT_RECRUITING

    Lyon, 69372, France

  • IInsitutul Clinic Fundeni, Sectia de Transplant Medular

    ACTIVE_NOT_RECRUITING

    Bucharest, Romania

  • Instituto Nacional de Peditria

    RECRUITING

    Mexico City, Mexico

  • Istituto Gaslini Genova Oncoematologia Pediatrica-

    WITHDRAWN

    Genoa, 16147, Italy

  • Karolinska University Hospital, Department of Pediatrics

    RECRUITING

    Stockholm, 14186, Sweden

  • King Abdullah specialists children hospital

    RECRUITING

    Riyadh, Saudi Arabia

  • Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM)

    ACTIVE_NOT_RECRUITING

    Frankfurt am Main, 60590, Germany

  • Klinikum der Universität München, Dr. von Haunersches Kinderspital

    ACTIVE_NOT_RECRUITING

    München, 80337, Germany

  • Lady Cilento Children's Hospital

    ACTIVE_NOT_RECRUITING

    South Brisbane, 4101, Australia

  • Leiden University Medical Center Department of Pediatrics/BMT unit

    COMPLETED

    Leiden, 2300, Netherlands

  • Medipol Mega Üniversite Hastanesi

    ACTIVE_NOT_RECRUITING

    Istanbul, Turkey (Türkiye)

  • Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin

    ACTIVE_NOT_RECRUITING

    Hanover, 30625, Germany

  • Montreal Children's Hospital

    ACTIVE_NOT_RECRUITING

    Montral, Canada

  • National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit

    RECRUITING

    Budapest, 1097, Hungary

  • Oslo University Hospital Rikshospitalet

    RECRUITING

    Oslo, 0424, Norway

  • Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti

    TERMINATED

    Torino, 10126, Italy

  • Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO

    WITHDRAWN

    Florence, 50139, Italy

  • Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome

    ACTIVE_NOT_RECRUITING

    Rome, 00165, Italy

  • Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT

    ACTIVE_NOT_RECRUITING

    Poznan, Poland

  • Princess Margaret Hospital for Children

    ACTIVE_NOT_RECRUITING

    Perth, 6008, Australia

  • Princess Máxima Center for Pediatric Oncology

    RECRUITING

    Utrecht, 3584, Netherlands

  • Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322)

    RECRUITING

    Gothenburg, 41685, Sweden

  • Rambam Medical Center

    ACTIVE_NOT_RECRUITING

    Haifa, 31096, Israel

  • Saint Sophia Children's Hospital BMT Unit

    RECRUITING

    Athens, 11527, Greece

  • Schneider Children's Medical Center of Israel

    ACTIVE_NOT_RECRUITING

    Petah Tikva, 49202, Israel

  • Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology

    RECRUITING

    Lund, 22185, Sweden

  • St. Anna Children's Hospital, Vienna, Austria

    RECRUITING

    Vienna, 1090, Austria

  • Starship Children's Hospital

    ACTIVE_NOT_RECRUITING

    Auckland, 1142, New Zealand

  • Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München

    ACTIVE_NOT_RECRUITING

    München, 80804, Germany

  • Sydney Children's Hospital

    ACTIVE_NOT_RECRUITING

    Randwick, 2031, Australia

  • The Children's Hospital at Westmead Oncology Unit

    ACTIVE_NOT_RECRUITING

    Sydney, 2145, Australia

  • UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie

    ACTIVE_NOT_RECRUITING

    Kiel, 24105, Germany

  • Uniklinik RWTH Aachen, Kinder- und Jugendmedizin

    ACTIVE_NOT_RECRUITING

    Aachen, 52074, Germany

  • University Children's Hospital

    RECRUITING

    Bratislava, 83340, Slovakia

  • University Children's Hospital in Krakow, Department of Transplantation

    WITHDRAWN

    Krakow, Poland

  • University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics

    RECRUITING

    Uppsala, 75185, Sweden

  • University Hospital Gent Pediatrische hemato-oncologie

    RECRUITING

    Ghent, 9000, Belgium

  • University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology

    ACTIVE_NOT_RECRUITING

    Bydgoszcz, Poland

  • University Hospitals Leuven Kinderhemato-oncologie

    RECRUITING

    Leuven, 3000, Belgium

  • University childrens' hospital, UMCL

    RECRUITING

    Ljubljana, Slovenia

  • University of Malaya, Department of Paediatrics

    RECRUITING

    Kuala Lumpur, Malaysia

  • University of Medicine and Pharmacy V. BABES, Emergency Children's Hospital LOUIS TURCANU, III. Clinic of Pediatrics , Department of Onco-hematology and Bone Marrow Transplantation

    COMPLETED

    Timișoara, Romania

  • Universitäts-Kinderklinik Würzburg

    ACTIVE_NOT_RECRUITING

    Würzburg, 97080, Germany

  • Universitäts-Kinderspital Zurich

    RECRUITING

    Zurich, 8032, Switzerland

  • Universitäts-Kinderspital beider Basel (UKBB)

    RECRUITING

    Basel, 4056, Switzerland

  • Universitätsklinik für Kinder- und Jugendheilkunde

    RECRUITING

    Innsbruck, 6020, Austria

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

    RECRUITING

    Graz, 8036, Austria

  • Universitätsklinik für Kinder- und Jugendmedizin Tübingen

    ACTIVE_NOT_RECRUITING

    Tübingen, 72076, Germany

  • Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie

    ACTIVE_NOT_RECRUITING

    Bonn, 53113, Germany

  • Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie

    ACTIVE_NOT_RECRUITING

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Erlangen, Kinder- und Jugendklinik

    ACTIVE_NOT_RECRUITING

    Erlangen, 1054, Germany

  • Universitätsklinikum Essen, Klinik für Kinderheilkunde III

    ACTIVE_NOT_RECRUITING

    Essen, 45122, Germany

  • Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin

    ACTIVE_NOT_RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin

    ACTIVE_NOT_RECRUITING

    Giessen, Gießen, 35392, Germany

  • Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin

    ACTIVE_NOT_RECRUITING

    Halle, 06120, Germany

  • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie

    ACTIVE_NOT_RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin

    ACTIVE_NOT_RECRUITING

    Heidelberg, 69120, Germany

  • Universitätsklinikum Jena, Sektion für Stammzelltransplantation

    ACTIVE_NOT_RECRUITING

    Jena, 07745, Germany

  • Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin

    ACTIVE_NOT_RECRUITING

    Münster, 48149, Germany

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin

    ACTIVE_NOT_RECRUITING

    Regensburg, 93053, Germany

  • Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin

    ACTIVE_NOT_RECRUITING

    Ulm, 89075, Germany

  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin

    ACTIVE_NOT_RECRUITING

    Greifswald, 17475, Germany

  • Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie

    ACTIVE_NOT_RECRUITING

    Leipzig, 04103, Germany

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