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Enzyme

Blinatumomab + Chemotherapy for Leukemia

Phase 3
Recruiting
Led By Sumit Gupta
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age at diagnosis: Patients must meet specific age criteria based on B-ALL or B-LLy diagnosis and presence of Down syndrome.
Patients must meet specific diagnostic criteria for B-cell ALL or B-cell LLy, with or without Down syndrome.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5.3 years
Awards & highlights

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.

Who is the study for?
This trial is for patients with newly diagnosed B-lymphoblastic leukemia/lymphoma, including those with Down syndrome. Participants must meet specific age and white blood cell count criteria and have not received prior cytotoxic chemotherapy (except certain steroids or intrathecal cytarabine). Exclusions include CNS3/testicular leukemia, secondary ALL from previous cancer treatment, Burkitt B-cell ALL, pregnancy, lactation.Check my eligibility
What is being tested?
The study tests blinatumomab combined with chemotherapy drugs like vincristine and methotrexate in treating standard risk B-ALL/B-LLy. It aims to see if this monoclonal antibody plus chemo improves outcomes compared to chemo alone. Patients are grouped by cancer recurrence risk to tailor the treatment regimen.See study design
What are the potential side effects?
Potential side effects include immune system changes leading to inflammation in organs, allergic reactions from monoclonal antibodies like blinatumomab, common chemotherapy-related issues such as nausea, hair loss, fatigue, increased infection risk and potential harm to liver or kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with B-ALL or B-LLy at an age that meets the trial's criteria, and I have Down syndrome.
Select...
I have been diagnosed with B-cell ALL or B-cell LLy, with or without Down syndrome.
Select...
My white blood cell count meets the criteria for someone with B-ALL and Down syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5.3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DFS in boys in the SR-favorable subset of SR B-ALL with or without Down syndrome (DS)
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
Secondary outcome measures
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
+7 more
Other outcome measures
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

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: NCI SR or HR DS B-ALLExperimental Treatment12 Interventions
See detailed description.
Group II: DS B-ALLExperimental Treatment13 Interventions
See detailed description.
Group III: B-LLyExperimental Treatment14 Interventions
See detailed description.
Group IV: Arm D (SR-High experimental)Experimental Treatment15 Interventions
Arm D See detailed description.
Group V: Arm B (SR-Avg experimental)Experimental Treatment13 Interventions
Arm B: See detailed description.
Group VI: Arm C (SR-High Control)Active Control14 Interventions
Arm C: See detailed description.
Group VII: Arm A (SR-Avg control)Active Control13 Interventions
Arm A: See detailed description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Mercaptopurine
2012
Completed Phase 4
~12330
Prednisolone
2005
Completed Phase 4
~2720
Radiation Therapy
2017
Completed Phase 3
~7250
Dexamethasone
2007
Completed Phase 4
~2590
Prednisone
2014
Completed Phase 4
~2370
Thioguanine
2012
Completed Phase 4
~10830
Vincristine Sulfate
2005
Completed Phase 3
~10150
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Leucovorin Calcium
2011
Completed Phase 3
~12310
Pegaspargase
2005
Completed Phase 3
~9010
Methotrexate
2013
Completed Phase 4
~3800
Blinatumomab
2014
Completed Phase 3
~1210
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,919,134 Total Patients Enrolled
Sumit GuptaPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many locations is this research project being conducted?

"In addition to Norton Children's Hospital in Louisville, Kentucky, Morristown Medical Center in Morristown, New jersey, and Santa Barbara Cottage Hospital in Santa Barbara, California, this study is also being conducted at 100 other medical facilities."

Answered by AI

What are researchers looking to achieve with this clinical trial?

"This trial's primary goal is to compare Disease free survival (DFS) rates in patients with higher risk features (SR-High) or standard risk average (SR-Avg) B-ALL, with the addition of blinatumomab. The trial will run for 5.1 years and secondary outcomes include DFS for patients with standard-risk favorable (SR-Fav) B-ALL when treated with a standard chemotherapy regimen, as well as DFS of DS-High B-ALL patients when intensive elements of chemotherapy are replaced with 3 cycles of blinatumomab. Additionally, the study aims to compare"

Answered by AI

Are we able to enroll new volunteers for this experiment at this time?

"Indeed, clinicaltrials.gov reflects that this clinical trial is still looking for participants. This research was originally posted on 6/28/2019 and has been updated as recently as 11/4/2022."

Answered by AI

Can adults of any age participate in this clinical research?

"Enrollment for this clinical trial is only possible for those between 1 and 31 years old."

Answered by AI

How many individuals are being monitored in this experiment?

"That is correct. The clinical trial was posted on 6/28/2019 and was most recently updated on 11/4/2022. The study is admitting 6720 participants across 100 locations."

Answered by AI

What are the risks associated with taking Arm B (SR-Avg experimental)?

"Arm B (SR-Avg experimental) of this Phase 3 clinical trial has received a score of 3 for safety by our analysts at Power. This is due to the presence of some efficacy data as well as multiple rounds of safety data."

Answered by AI

What is the common purpose of Arm B (SR-Avg experimental)?

"Arm B (SR-Avg experimental) is the most common intervention for ulcerative colitis. It is also taken to treat other conditions including multiple myeloma, eye, and subarachnoid block."

Answered by AI

Is Arm B (SR-Avg experimental) the only group that has been studied in this way?

"There are a total of 2344 clinical trials ongoing for Arm B (SR-Avg experimental). 541 of these are in Phase 3. The epicentre for these trials is Changsha, Hunan, but there are 78256 total locations running these trials."

Answered by AI

How do I go about signing up for this clinical trial?

"This clinical trial is recruiting 6720 patients, between the ages of 1 and 31, who have down syndrome. In order to participate, patients must meet the following criteria: Patients must be between 1 and 31 years of age (B-ALL patients with DS)., Patients must be between 1 and 31 years of age (B-LLy patients with or without DS)., B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment)., B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC"

Answered by AI
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~3501 spots leftby Jun 2029