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
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.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Mixed Phenotype Acute Leukemia
  • B-Cell Lymphoblastic Lymphoma
  • Testicular Leukemia
  • Central Nervous System Leukemia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

Study Objectives

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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

Trial Design

5 Treatment Groups

Arm II (HR B-ALL CONTROL)
1 of 5
Arm I (HR-FAV B-ALL)
1 of 5
ARM V (B-LLY)
1 of 5
Arm III (HR B-ALL EXPERIMENTAL)
1 of 5
Arm IV (MPAL)
1 of 5

Active Control

Experimental Treatment

4772 Total Participants · 5 Treatment Groups

Primary Treatment: Arm I (HR-FAV B-ALL) · No Placebo Group · Phase 3

Arm I (HR-FAV B-ALL)Experimental Group · 14 Interventions: Questionnaire Administration, Daunorubicin Hydrochloride, Cytarabine, Methotrexate, Vincristine Sulfate, Calaspargase Pegol-mknl, Doxorubicin Hydrochloride, Thioguanine, Leucovorin Calcium, Dexamethasone, Pegaspargase, Prednisolone, Mercaptopurine, Cyclophosphamide · Intervention Types: Other, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
ARM V (B-LLY)Experimental Group · 14 Interventions: Questionnaire Administration, Daunorubicin Hydrochloride, Cytarabine, Methotrexate, Vincristine Sulfate, Calaspargase Pegol-mknl, Doxorubicin Hydrochloride, Thioguanine, Leucovorin Calcium, Dexamethasone, Pegaspargase, Prednisolone, Radiation Therapy, Cyclophosphamide · Intervention Types: Other, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Radiation, Drug
Arm III (HR B-ALL EXPERIMENTAL)Experimental Group · 15 Interventions: Questionnaire Administration, Daunorubicin Hydrochloride, Cytarabine, Methotrexate, Inotuzumab Ozogamicin, Vincristine Sulfate, Calaspargase Pegol-mknl, Doxorubicin Hydrochloride, Thioguanine, Leucovorin Calcium, Dexamethasone, Pegaspargase, Radiation Therapy, Mercaptopurine, Cyclophosphamide · Intervention Types: Other, Drug, Drug, Drug, Biological, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Radiation, Drug, Drug
Arm IV (MPAL)Experimental Group · 15 Interventions: Questionnaire Administration, Daunorubicin Hydrochloride, Cytarabine, Methotrexate, Vincristine Sulfate, Calaspargase Pegol-mknl, Doxorubicin Hydrochloride, Thioguanine, Leucovorin Calcium, Dexamethasone, Pegaspargase, Prednisolone, Radiation Therapy, Mercaptopurine, Cyclophosphamide · Intervention Types: Other, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Radiation, Drug, Drug
Arm II (HR B-ALL CONTROL)ActiveComparator Group · 15 Interventions: Questionnaire Administration, Daunorubicin Hydrochloride, Cytarabine, Methotrexate, Vincristine Sulfate, Calaspargase Pegol-mknl, Doxorubicin Hydrochloride, Thioguanine, Leucovorin Calcium, Dexamethasone, Pegaspargase, Prednisolone, Radiation Therapy, Mercaptopurine, Cyclophosphamide · Intervention Types: Other, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Radiation, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin
FDA approved
Cytarabine
FDA approved
Methotrexate
FDA approved
Inotuzumab ozogamicin
FDA approved
Vincristine
FDA approved
Asparaginase Escherichia coli
FDA approved
Doxorubicin
FDA approved
Tioguanine
FDA approved
Levoleucovorin
FDA approved
Dexamethasone
FDA approved
Pegaspargase
FDA approved
Prednisolone
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Mercaptopurine
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
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.