Arm I (HR-FAV B-ALL) for Acute Lymphoblastic Leukemia
Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Acute Lymphoblastic Leukemia+4 MoreQuestionnaire Administration - Other
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Eligibility
1 - 24
All Sexes
What conditions do you have?
Select
Eligibility
1 - 24
All Sexes
What conditions do you have?
Select
Study Summary
This trial is studying whether adding inotuzumab ozogamicin to standard chemotherapy for high-risk B-cell acute lymphoblastic leukemia (B-ALL) improves outcomes.
1 Primary · 4 Secondary · Reporting Duration: From study entry to first event (induction failure, Induction death, end of induction (EOI) minimal residual disease (MRD) >= 5%, EOC MRD >= 0.01%, relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years
Year 5
5-year DFS for favorable risk subset of NCI HR B-ALL (HR favorable) when treated with mBFM chemotherapy with a single high-dose methotrexate (HD MTX) Interim Maintenance (IM) phase and treatment duration of 2 years from the start of IM regardless of sex
Year 5
Improvement in 5-year disease-free survival (DFS) after adding 2 blocks of inotuzumab ozogamicin (InO) to Berlin-Frankfurt-Munster (mBFM) chemotherapy in children and young adults with High-Risk (HR) B-ALL
Year 5
5-year event-free survival (EFS) for patients with mixed phenotype acute leukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzi escalating intravenous MTX without leucovorin rescue plus pegaspargase (C-MTX)
Year 5
5-year EFS for patients with disseminated (Murphy stage III-IV) B-cell lymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IM phase with C-MTX
Up to 5 years
Disease response in patients with MPAL who come off protocol therapy due to poor disease response to ALL therapy
Impact of four proposed interventions of varying intensities to enhance adherence to oral 6 mercaptopurine, with a randomization based upon baseline adherence measured during the first cycle of maintenance therapy
Incidence of adverse events for the integration of inotuzumab ozogamicin into the mBFM chemotherapy backbone in HR B-ALL
Prevalence and significance of minimal marrow disease (MMD) at diagnosis and bone marrow MRD in disseminated B-LLy
Survival outcomes of patients with MPAL who come off protocol therapy due to poor disease response to ALL therapy
Therapy administered to patients with MPAL who come off protocol therapy due to poor disease response to ALL therapy
Reporting: from study entry to first event (induction failure, induction death, end of induction (eoi) minimal residual disease (mrd) >= 5%, eoc mrd >= 0.01%, relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
448 Previous Clinical Trials
231,738 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,124,081 Total Patients Enrolled
Jennifer L McNeerPrincipal InvestigatorChildren's Oncology Group
Eligibility Criteria
Age 1 - 24 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:
Any WBC\n
You have testicular leukemia.
You have CNS leukemia.
If you are aged 18 years or older, you have a BM aspirate, and you have a pathologic diagnosis of acute leukemia on a BM biopsy, you have acute leukemia.