Arm B (SR-Avg experimental) for Down Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Down Syndrome+7 More
Mercaptopurine Oral Suspension - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well blinatumomab works with chemotherapy in treating patients with newly diagnosed B-cell acute lymphoblastic leukemia or B-lymphoblastic lymphoma.

Eligible Conditions
  • Down Syndrome
  • B Acute Lymphoblastic Leukemia
  • B Lymphoblastic Lymphoma

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: 5.3 years

1 year
Defecation
Caregiver burden as measured by the At-Work Productivity Loss summary score from the Caregiver Work Limitations questionnaire among a subset of children enrolled in the HMH and neurocognitive outcome study
Caregiver burden as measured by the Mean Total score from the Care of My Child with Cancer questionnaire among a subset of children enrolled in the HMH and neurocognitive outcome study
Bone Marrow
2.3 years
Treatment-related mortality in Down syndrome high risk (DS-high) patients after replacement of intensive elements of standard chemotherapy (omission of anthracyclines in induction, omission of the second month of DI) with 3 cycles of blinatumomab
3.3 years
Change in neurocognitive functioning from baseline to end-of-therapy between children from poor (defined as presence of household material hardship [HMH], including either food, housing or energy insecurity) and non-poor families (absence of HMH)
5 years
DFS of patients with localized B-lymphoblastic lymphoma (B-LLy) receiving standard risk acute lymphoblastic leukemia therapy
Neurocognitive, functional, and quality of life outcomes in patients with DS and ALL
Prevalence of minimal marrow disease (MMD) in B-LLy
To explore adaptive and innate immune functions and host genetic factors associated with severe infectious complications in children with DS B-ALL
5.1 years
DFS for patients with SR-Avg B-ALL who are negative for MRD measured by flow cytometry and HTS at EOI when treated with standard chemotherapy with a treatment duration of 2 years from the start of interim maintenance (IM)1, regardless of sex
DFS for patients with standard-risk favorable (SR-Fav) B-ALL when treated with a standard chemotherapy regimen
DFS in boys in the SR-favorable subset of SR B-ALL with or without Down syndrome (DS)
5.3 years
DFS of DS-High B-ALL patients when intensive elements of chemotherapy are replaced with 3 cycles of blinatumomab
Disease free survival (DFS) in randomization eligible patients with higher risk features (SR-High) or standard risk average (SR-Avg) B-ALL patients based on randomization with addition of blinatumomab

Trial Safety

Safety Progress

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

Trial Design

7 Treatment Groups

Arm C (SR-High Control)
1 of 7
Arm A (SR-Avg control)
1 of 7
Arm B (SR-Avg experimental)
1 of 7
B-LLy
1 of 7
NCI SR or HR DS B-ALL
1 of 7
Arm D (SR-High experimental)
1 of 7
DS B-ALL
1 of 7

Active Control

Experimental Treatment

6720 Total Participants · 7 Treatment Groups

Primary Treatment: Arm B (SR-Avg experimental) · No Placebo Group · Phase 3

Arm B (SR-Avg experimental)Experimental Group · 13 Interventions: Mercaptopurine Oral Suspension, Dexamethasone, Thioguanine, Vincristine Sulfate, Doxorubicin Hydrochloride, Leucovorin Calcium, Mercaptopurine, Pegaspargase, Methotrexate, Asparaginase Erwinia chrysanthemi, Blinatumomab, Cyclophosphamide, Cytarabine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Biological, Drug, Drug
B-LLyExperimental Group · 14 Interventions: Mercaptopurine Oral Suspension, Dexamethasone, Prednisolone, Prednisone, Thioguanine, Vincristine Sulfate, Doxorubicin Hydrochloride, Leucovorin Calcium, Mercaptopurine, Pegaspargase, Methotrexate, Asparaginase Erwinia chrysanthemi, Cyclophosphamide, Cytarabine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
NCI SR or HR DS B-ALLExperimental Group · 12 Interventions: Mercaptopurine Oral Suspension, Dexamethasone, Prednisolone, Prednisone, Vincristine Sulfate, Doxorubicin Hydrochloride, Leucovorin Calcium, Mercaptopurine, Pegaspargase, Methotrexate, Asparaginase Erwinia chrysanthemi, Blinatumomab · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Biological
Arm D (SR-High experimental)Experimental Group · 15 Interventions: Mercaptopurine Oral Suspension, Dexamethasone, Prednisolone, Prednisone, Thioguanine, Vincristine Sulfate, Doxorubicin Hydrochloride, Leucovorin Calcium, Mercaptopurine, Pegaspargase, Methotrexate, Asparaginase Erwinia chrysanthemi, Blinatumomab, Cyclophosphamide, Cytarabine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Biological, Drug, Drug
DS B-ALLExperimental Group · 13 Interventions: Mercaptopurine Oral Suspension, Dexamethasone, Radiation Therapy, Thioguanine, Vincristine Sulfate, Doxorubicin Hydrochloride, Leucovorin Calcium, Mercaptopurine, Pegaspargase, Methotrexate, Asparaginase Erwinia chrysanthemi, Cyclophosphamide, Cytarabine · Intervention Types: Drug, Drug, Radiation, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Arm C (SR-High Control)ActiveComparator Group · 14 Interventions: Mercaptopurine Oral Suspension, Dexamethasone, Prednisolone, Prednisone, Thioguanine, Vincristine Sulfate, Doxorubicin Hydrochloride, Leucovorin Calcium, Mercaptopurine, Pegaspargase, Methotrexate, Asparaginase Erwinia chrysanthemi, Cyclophosphamide, Cytarabine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Arm A (SR-Avg control)ActiveComparator Group · 13 Interventions: Mercaptopurine Oral Suspension, Dexamethasone, Prednisone, Thioguanine, Vincristine Sulfate, Doxorubicin Hydrochloride, Leucovorin Calcium, Mercaptopurine, Pegaspargase, Methotrexate, Asparaginase Erwinia chrysanthemi, Cyclophosphamide, Cytarabine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Prednisone
FDA approved
Prednisone
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080
Tioguanine
FDA approved
Sulfate ion
Not yet FDA approved
Doxorubicin
FDA approved
Leucovorin
FDA approved
Mercaptopurine
FDA approved
Asparaginase Escherichia coli
FDA approved
Methotrexate
FDA approved
Blinatumomab
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5.3 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,001 Previous Clinical Trials
41,294,272 Total Patients Enrolled
10 Trials studying Down Syndrome
10,939 Patients Enrolled for Down Syndrome
Sumit GuptaPrincipal InvestigatorChildren's Oncology Group

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have at least 1,000/uL circulating leukemic cells.
You are between 0 and 10 years of age.\n
A diagnosis of B-ALL can be established by a pathologic diagnosis of B-ALL on a BM biopsy.
You have B-cell lymphoma of the small intestine.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: November 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.