Study on Tioguanine and Drug Combination for Patients Aged 0-45 with Newly Diagnosed Acute Lymphoblastic Leukemia

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What is this study about?

This clinical trial is focused on studying treatments for Acute Lymphoblastic Leukemia (ALL), a type of cancer that affects the blood and bone marrow. The study aims to improve the survival and quality of life for children and young adults diagnosed with this disease. Participants in the trial will receive various treatments, including medications like Tioguanine, Hydrocortisone Sodium Succinate, Mercaptopurine, Blinatumomab, Vincristine Sulfate, Doxorubicin, Dexamethasone, Methotrexate, Imatinib, Inotuzumab Ozogamicin, Methylprednisolone Sodium Succinate, Prednisolone Sodium Succinate, and Cytarabine. Some participants may receive a placebo as part of the study.

The purpose of the study is to test these treatments in a structured way to see how well they work and to gather information about their effects. The study will involve different phases where participants will receive these treatments over a period of time. The treatments will be given in various forms, such as oral suspensions, tablets, or injections, depending on the specific medication. The study will also explore the potential benefits of new types of treatments, such as immunotherapy, for certain groups of patients.

Throughout the study, participants will be monitored to assess the effectiveness of the treatments and to identify any side effects. The study will collect data on survival rates, the occurrence of any relapses, and the overall quality of life of the participants. This information will help researchers understand how these treatments can be used to improve outcomes for people with Acute Lymphoblastic Leukemia.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of acute lymphoblastic leukaemia (ALL). This involves a series of tests and evaluations to ensure eligibility for the trial.

2 treatment initiation

The treatment phase begins with the administration of various medications. These include tioguanine and mercaptopurine taken orally, and vincristine sulfate and doxorubicin given intravenously. The specific dosage and frequency are determined by the medical team based on individual needs.

3 intrathecal therapy

Intrathecal therapy involves administering medications directly into the spinal fluid. This includes methotrexate and cytarabine. This step is crucial for targeting leukaemia cells in the central nervous system.

4 oral medication phase

During this phase, oral medications such as dexamethasone and imatinib are taken regularly. The medical team provides specific instructions on dosage and timing.

5 monitoring and adjustments

Regular monitoring is conducted to assess the response to treatment. Adjustments to the medication regimen may be made based on these assessments to optimize outcomes.

6 maintenance therapy

Maintenance therapy involves continued use of certain medications to prevent relapse. This phase includes oral medications like mercaptopurine and methotrexate, taken over an extended period.

7 follow-up and evaluation

After completing the treatment phases, regular follow-up appointments are scheduled to monitor long-term health and detect any potential recurrence of leukaemia.

Who Can Join the Study?

  • Patients must be newly diagnosed with either T-lymphoblastic (T-cell) leukaemia or B-lymphoblastic precursor (BCP) leukaemia. These are specific types of blood cancer.
  • The diagnosis must be confirmed by a recognized laboratory at a participating children’s cancer center or adult blood disease center.
  • Patients must be between the ages of 0 days and less than 46 years old at the time of diagnosis.
  • Patients with a specific genetic feature called surface IG negative BCP-ALL and an IG::MYC rearrangement can participate, unless they have another genetic feature called BCL2/6 rearrangement. T-ALL patients with MYC translocations are also eligible.
  • Informed consent must be signed by the patient and/or their parents/legal guardians, following the guidelines specific to their country.
  • The patient must be diagnosed and treated at a participating children’s cancer center or adult blood disease center in the participating countries.
  • The patient should live permanently in one of the participating countries or plan to settle there, such as applying for asylum. Tourists are not eligible, but returning expatriates with a primary diagnosis from abroad may be included if no treatment has been given and diagnostic tests are repeated at a participating center.
  • All women who can have children must have a negative pregnancy test within 2 weeks before starting treatment.
  • Additional criteria may apply for each specific treatment or randomization within the study.

Who Cannot Join the Study?

  • Patients who do not have Acute Lymphoblastic Leukaemia cannot participate.
  • Patients who are not infants, children, or young adults are excluded.
  • Patients who are not part of the specified clinical trial groups are excluded.
  • Patients who are not considered part of a vulnerable population are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De La Reunion St Denis France
Region Skane Skanes Universitetssjukhus Lund Sweden
Centre Hospitalier Universitaire De Poitiers Poitiers France
HELIOS Klinikum Krefeld GmbH Krefeld Germany
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Centre Hospitalier Regional De La Citadelle Liege Belgium
St. Olavs Hospital HF Trondheim Norway
Helse Stavanger HF Stavanger Norway
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
Pohjois-Pohjanmaan hyvinvointialue Oulu Finland
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Tartu University Hospital Tartu Estonia
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Hospital Universitario De Cruces Barakaldo Spain
University Hospital Galway Galway Ireland
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Centre Hospitalier Universitaire De Montpellier Montpellier France
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Aalborg University Hospital Aalborg Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
CHC MontLegia Liege Belgium
Centre Hospitalier Universitaire De Nice Nice France
Tallinn Children’s Hospital Foundation Mustamae Linnaosa Estonia
Region Midtjylland Aarhus Denmark
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Rigshospitalet Copenhagen Denmark
Pohjois-Savon hyvinvointialue Kuopio Finland
Pirkanmaan hyvinvointialue Tampere Finland
Region Oerebro Laen Orebro Sweden
Region Vaesterbotten Umea Sweden
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
University Childrens Hospital Queen Fabiola Brussels Belgium
Servei De Salut De Les Illes Balears Palma Spain
Region Uppsala Uppsala Sweden
Region Oestergoetland Linkoping Sweden
Region Stockholm – SLSO Stockholm Sweden
Centre Hospitalier Universitaire De Caen Normandie Caen France
North Estonia Medical Centre Foundation Tallin Estonia
Children’s Health Ireland Dublin Ireland
Cntcjlgbi Upeoemadgvcgfo Sskuimkii Woluwe-Saint-Lambert Belgium
Vljxdmrytiexjmdi hddbdiwiziyupca Turku Finland
Uwbswzvhup Mnhhymi Cvqivz Hnvgpvqjhpcngrwhc Hamburg Germany
Cipocb Himxlcklbnl Uvjrzxifrtoxz Rmhbl Reims France
Cxgc Uaahyalmrz Htjcswzw Cork Ireland
Cfdfjb Hriycbbcfjt Ec Uvpuucaqhdskt Dr Ldoybos Limoges France
Cdfodc Hjrueebehsw Uvwcvngwnseng Df Dfewd Dijon France
Aaebafdwiy Pcatrepq Hlqoxdqn Di Mdrbzunbw Marseille France
Htauy Bqxdkg Hv Bergen Norway
Bscwqeub Upzsqaivgm Hxacsyxr Cpeiaq Besançon France
Hdllzvty Uajuntjxfl Czedukt Haoswear Helsinki Finland
Aovhjx Upfbkhjadk Hochdmsp Aarhus Denmark
Ctqemd Hkulvtrrari Rpcxwnmp Udvobuqbpbkup Dp Tfilk Tours France
Crzw Db Numwy Vandoeuvre Les Nancy France
Ujmirchnrj Ou Azkjaar Edegem Belgium
Cwakgr Hfkhbvclcbm Rwfevgzz Dwzmsxrfswysea Angers France
Frfnyyayu Prno Lo Ijsntkkgkmsfp Btcciwfzl Dxk Hqavndkn Uybhiykgnzudo Lq Pex Madrid Spain
Igvcwyqh dh Cboqiqhubfby Hwdywdgzcoo Ulvottmpsjlvw dd Sjpak Epomrus (cejogea Saint Priest En Jarez France
Hynbqqpg Vkzb drnwxfbo Barcelona Spain
Htqnncfd Ucgbskhgiiahuv Sqbrniebom &bnblxh Hekvupz dp Hmxlhemdnew STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
13.07.2020
Denmark Denmark
Recruiting
13.07.2020
Estonia Estonia
Recruiting
13.07.2020
Finland Finland
Recruiting
13.07.2020
France France
Recruiting
13.07.2020
Germany Germany
Recruiting
13.07.2020
Iceland Iceland
Recruiting
13.07.2020
Ireland Ireland
Recruiting
13.07.2020
Lithuania Lithuania
Recruiting
13.07.2020
Norway Norway
Recruiting
13.07.2020
Portugal Portugal
Recruiting
13.07.2020
Spain Spain
Not yet recruiting
13.07.2020
Sweden Sweden
Recruiting
13.07.2020
The Netherlands The Netherlands
Recruiting
13.07.2020

Trial locations

Immunotherapy is a type of treatment that helps your immune system fight cancer. In this trial, a subgroup of patients with acute lymphoblastic leukemia (ALL) may receive a novel form of immunotherapy. This therapy works by boosting the body’s natural defenses to recognize and attack cancer cells more effectively.

Acute Lymphoblastic Leukaemia – Acute Lymphoblastic Leukaemia is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as lymphoblasts. These abnormal cells crowd out normal blood cells, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses rapidly, requiring prompt medical attention. As the condition advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression of the disease can vary, with some cases advancing more quickly than others.

Trial ID:
2022-501050-11-01
Protocol code:
ALLTogether1
NCT ID:
NCT04307576
Trial Phase:
Therapeutic use (Phase IV)

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