RecruitingPhase IIEN originalLeukemia

Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma. Primary Objective * To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131. Secondary Objectives * To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17. * To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17. * To assess the event free and overall survival of patients treated with this therapy.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek od 1 do 18,99 lat w momencie włączenia do badania
  • Rozpoznana białaczka limfoblastyczna lub chłoniak limfoblastyczny typu B-komórkowego
  • Brak wcześniejszej chemioterapii (oprócz leczenia dozwolonego w ramach innego badania INITIALL)
  • Należenie do grupy wysokiego ryzyka wg kryteriów NCI lub grupa standardowego ryzyka ze szczególnymi czynnikami ryzyka
  • Prawidłowe funkcje wątroby (parametry bilirubiny i transaminaz w normie)
  • Prawidłowe funkcje nerek (parametry funkcji nerek odpowiednie dla wieku)
  • Dla chłoniaków limfoblastycznych: stadium 3-4 lub stadium 1-2 u pacjentów powyżej 10 lat
  • Włączenie do badania INITIALL

Simplified criteria — AI translation

Trial details

Minimum age
1 Year
Maximum age
18 Years
Last updated (source)
July 16, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (3)

Novant Health Presbyterian Hemby Children's Hospital

Charlotte, United States

Saint Francis Children's Hospital

Tulsa, United States

St. Jude Children's Research Hospital

Memphis, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/17/2026.

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