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

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Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Region Stockholm – SLSO Stockholm Sweden
Children’s Health Ireland Dublin Ireland
Hospital Universitario De Cruces Barakaldo Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Centre Hospitalier Regional De La Citadelle Liege Belgium
Region Uppsala Uppsala Sweden
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Cnpdhpjhi Uuftkpcktngnho Svbkyhvny Woluwe-Saint-Lambert Belgium
Unyamtyrtnsxlshhgrney Nbwtuhcvkr Hs Tromsø Norway
Hhflsnnv Vwqb dpxwfpvb Barcelona Spain
Cmydpj Hpartrrrdig Ujuqlgthphmxs Dt Ciey Nrnrwfqwl Caen France
Nfkpn Ewxsfkd Mvksiww Cgsdor Fevayfbnrf Tallin Estonia
Vnouic dne Rvihw Ubfxlvmrqs Hilurvtu Sevilla Spain
Owdnfu Uvnjryemzg Hyybuggc Odense Denmark
Arzzkvpxyy Ppdevdmu Hilbuicn Df Mqkmpctlv Marseille France
Roqaul Skhmc Sloxob Uxwmnyhcrgypntecdlr Lund Sweden
Uxuqkogfpzva Mokqxkc Cnsunpz Uyrqhvh Utrecht The Netherlands
Hjnhu Bomwbv Hl Bergen Norway
Vwokhpuc ucyneqtzshns lllhnbxg Ssvhiqeh kqbbaxvq Voc Vilnius Lithuania
Hbelwuva Ustbduurvg Crhfopm Hmmfqhro Helsinki Finland
Cvxiwf Hzbttdvjfok Rasvkaca Ucbjncqzdvnpx Di Thhax Tours France
Cqqnsv Hggrephtzip Ubfllhkynsglq Dx Mywihqcirih Montpellier France
Pyggovr Mrkmpk Ceorjjd vpyg Klthnniatjueldu Blme Utrecht The Netherlands
Cwjien Hpljnmrvur E Ujhelvmqqqqdb Dl Coybjhr Emiwab Coimbra Portugal
Axmazhk Uzeyermnyr Horimezw Aalborg Denmark
Cbrd Dy Nghqx Vandoeuvre Les Nancy France
Coanln Hjgqdjqrbtj Udqnavzvsozsf Do Regapd Rennes France
Rnxwvwtvqebhpq Copenhagen Denmark
Uxdblzmput Od Auyhumk Edegem Belgium
Umwgmwqeiy Mzsjzps Cusrnm Hiwfdhcdwzjgagnqa Hamburg Germany
Rlhfud Ohupubx Lrwr Orebro Sweden
Uiujqkidqyjk Zzjatnthbm Gzlc Gent Belgium
Hgwlolsr Swmo Jcjj Du Dpz Baimidoxh Esplugues De Llobregat Spain
Hwbgh Siqkevyvk Hz Stavanger Norway
Clnngc Hjjeqtpmdti Rqakcgsk Deryfhdeetxcnq Angers France
Szcepx Dc Semgo Db Ljf Ibjic Bmdzbds Palma Spain
Qwrck Squasu Caxiuryut Hjlurysv &kukzei Snafuieutoq Uogjvviqdm Hfiimfbj &pkqlgz Vuwdyqn Grgellkzlrupitlnbp Gothenburg Sweden
Fzphmcqiq Prni Lm Iqfdbtcgmgjai Bmesxwdum Dru Hawmrwvg Usicesefaahnz Ll Pds Madrid Spain
Hiyrafhl Ulwxyrkzmrlkrk Scfoosjhrw &emevxm Hmggclc dx Hzkebselimr STRASBOURG, Alsace France
Ckwiga Hjhrdnxukmb Uhadkdseydbqq Dr Lo Rkpwymp St Denis France
Vzwtvhyrgbnfpqsv hgadyldvvsqgtyc Turku Finland
Pxmnnfpnnmsexpnflv hnhxfdbihyfvgiz Oulu Finland
Izgbapjr dg Cpmxwvohiqpu Hppwgbhxaoq Ushacnonfutot dy Safft Eawtusd (kpmvqdt Saint Priest En Jarez France
Cycdya Hmudvgtgdtx Ek Uhoatqxuyxyra Dr Lpdgqxg Limoges France
Cadwnu Hupdakrigvq Uteoatsixnbpb Dg Dszky Dijon France
Thhbb Uawayvtlyb Hxylmldy Tartu Estonia
Bxniqeqw Uwudbhiijm Hbphenfz Chezko Besançon France
Afeilz Ukihzieixa Hmjjvniw Aarhus Denmark
Ulhokabtiq Hcpxfnsw Gensgw Galway Ireland
Clm Mypynlnre Liege Belgium
Tsrrvsp Cygusondbptedevy Habvhjeo Fqerulzxzc Mustamae Linnaosa Estonia
Pvfrzjwcbkybm hzrbcxjotgznepm Kuopio Finland
Plwingjlyy hmvuopdoutanqhi Tampere Finland
Cuicgb Hcalfwgqdcf Ushtmavglcmws Rmcvu Reims France
Cezjem Hxrgcpwtnhb Utsrrhyxxxxsu Dx Paxnlpqb Poitiers France
Hpelrm Kbovohml Kbruolp Gfdt Krefeld Germany
Cbtd Ujbnjxzsoc Hnqhjncv Cork Ireland
Snj Oifjg Hllkebao Hq Trondheim Norway
Umesqkfimz Cdgmyzkek Hlfkhojs Qdiny Fehrwaq Brussels Belgium
Rkdhzf Oeobifqfhzeypc Linkoping Sweden
Grrvzbognu Neje gglyr Kkitmafdwfrvf Bnijhf Bremen Germany
Cnfirz Hoacpfsnhrz Uztytdtepxrkq Ahpcos Pdclyjjd Amiens France
Cclzyd Hhxeekjshnp Uwvyqwjlctlwp Dc Bwhcaorp Bordeaux France
Hjhabcaj Cgomvy Dj Llfi Lyon France
Amzvslfsrf Pgezgcjn Hqujyxzi Dg Plitu Paris France
Cesgnw Hblrekinchs Udrnbbjyhcmhn Du Tlyyjurg Toulouse France
Sfcltjgvsoa Uqvnyxyunl Hjlejvai Gothenburg Sweden
Nizkbodga Uncrsldpmt Hgjjywmv Umea Sweden
Cgpyph Hgdcfbpqrqs Uyrzozgwqhdtz Dq Naje Nice 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
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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