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BiTE Antibody

Blinatumomab for Acute Lymphoblastic Leukemia

Phase 3

Waitlist Available

Led By Patrick A Brown

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

No prior treatment with blinatumomab

Performance status corresponding to ECOG scores of 0, 1, or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study Summary

This trial compares blinatumomab with standard chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.

Who is the study for?

This trial is for young patients under 31 years old with a first relapse of B-cell acute lymphoblastic leukemia. They must not have had prior stem cell transplants or blinatumomab treatment, and their major organs need to function well. Patients with HIV, pregnant or breastfeeding women, and those with certain genetic syndromes or significant CNS pathology are excluded.Check my eligibility

What is being tested?

The trial is testing the effectiveness of blinatumomab (an immunotherapy) against standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia. It aims to see if blinatumomab can better engage the immune system to attack leukemia cells compared to traditional treatments.See study design

What are the potential side effects?

Blinatumomab may cause side effects like allergic reactions, fever, headache, nausea, fatigue, and an increased risk of infections. Chemotherapy can lead to hair loss, mouth sores, low blood cell counts increasing infection risk and bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never been treated with blinatumomab.

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I can take care of myself but may not be able to do heavy physical work.

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My heart is functioning within normal limits.

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My kidney function is appropriate for my age and gender.

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My B-ALL cancer has returned for the first time.

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I am between 1 and 30 years old and my cancer has returned.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients

Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients

Secondary outcome measures

Overall Survival (OS) of HR and IR Relapse Patients

Overall Survival (OS) of LR Relapse Patients

Other outcome measures

Blinatumomab Pharmacokinetics (PK)

Feasibility of Rapid Taper of Immune Suppression for Subset of HSCT Patients With MRD >= 0.01% Pre- and/or Post-HSCT With no Acute Graft Versus Host Disease (aGVHD)

Hematologic Complete Remission Rate (for Treatment Failure Patients Not Previously Receiving Blinatumomab)

+4 more

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575

Hypoxia

Febrile neutropenia

Acute kidney injury

Blood bilirubin increased

Diarrhea

Creatinine increased

Sepsis

Hypotension

Left ventricular systolic dysfunction

Bronchopulmonary hemorrhage

Chronic kidney disease

Thromboembolic event

Lung infection

Atrial fibrillation

Atrial flutter

Hemolysis

Hemolytic uremic syndrome

Ejection fraction decreased

Encephalitis infection

Gastric hemorrhage

Gastritis

Heart failure

Mucositis oral

Multi-organ failure

Myalgia

Pleural effusion

Respiratory failure

Small intestine infection

Syncope

Treatment related secondary malignancy

Typhlitis

Fever

Paroxysmal atrial tachycardia

Ascites

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Fludarabine, Transplant, Immunosuppression)

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm D (LR blinatumomab)Experimental Treatment15 Interventions

Patients receive Block 2 over 4 weeks, Blinatumomab Cycle 1 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Cycle 2 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Cycle 3 over 5 weeks, and then Maintenance.

Group II: Arm B (HR and IR blinatumomab)Experimental Treatment7 Interventions

Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT.

Group III: Arm C (LR control)Active Control15 Interventions

Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance.

Group IV: Arm A (HR and IR control)Active Control15 Interventions

Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT. Closed effective September 18, 2019.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3780

Dexamethasone

2007

Completed Phase 4

~2590

Mercaptopurine

2012

Completed Phase 4

~12330

Blinatumomab

2014

Completed Phase 3

~1210

Methotrexate

2013

Completed Phase 4

~3800

Leucovorin Calcium

2011

Completed Phase 3

~12290

Cytarabine

2016

Completed Phase 3

~3310

Etoposide

2010

Completed Phase 3

~2440

Thioguanine

2012

Completed Phase 4

~10830

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Radiation Therapy

2017

Completed Phase 3

~7250

Vincristine

2003

Completed Phase 4

~2910

Vincristine Sulfate

2005

Completed Phase 3

~10110

Pegaspargase

2005

Completed Phase 3

~9010

Therapeutic Hydrocortisone

2012

Completed Phase 3

~340

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,484 Total Patients Enrolled

Patrick A BrownPrincipal InvestigatorChildren's Oncology Group

Media Library

Blinatumomab (BiTE Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT02101853 — Phase 3

Acute Lymphoblastic Leukemia Research Study Groups: Arm C (LR control), Arm D (LR blinatumomab), Arm A (HR and IR control), Arm B (HR and IR blinatumomab)

Acute Lymphoblastic Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT02101853 — Phase 3

Blinatumomab (BiTE Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02101853 — Phase 3

Frequently Asked Questions

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

At how many locations is this research being conducted?

"This trial has sites at Legacy Emanuel Children's Hospital in Portland, Oregon; Dayton Children's Hospital in Dayton, Ohio; IWK Health Centre in Halifax, Nova Scotia; and 100 other locations."

Answered by AI

What are some of the reasons that Allogeneic Hematopoietic Stem Cell Transplantation is often prescribed?

"Allogeneic Hematopoietic Stem Cell Transplantation is a common treatment for nephrotic syndrome. This method can also be used to help treat other conditions such as amino acid supplementation therapy, merkel cell cancer, and leukemia."

Answered by AI

Does this study allow for patients who are over 50 years old?

"As per the age requirements set out in this clinical trial's inclusion criteria, eligible patients must be between 1 and 30 years old."

Answered by AI

Are there precedent cases for this Allogeneic Hematopoietic Stem Cell Transplantation?

"There are 2173 active studies and 495 in Phase 3 specifically for Allogeneic Hematopoietic Stem Cell Transplantation. Changsha, Hunan has a high density of these trials with 72840 locations running trials total."

Answered by AI

How do I sign up for this experiment?

"This study is recruiting 670 patients, within the ages of 1 Year and 30 who currently have leukemia. It is important that patients also meet the following criteria: Patients who relapse on frontline therapy in phases other than maintenance must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, With the exception of intrathecal chemotherapy (methotrexate strongly preferred; cytarabine is permissible) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status, patient has not received prior relapse-directed therapy (i.e.,"

Answered by AI

How many individuals are involved in this clinical trial?

"As of May 27th, 2022, this particular clinical trial is no longer recruiting participants. The study was first posted on December 8th, 2014. For anyone looking for similar studies, there are 1547 trials for leukemia and 2173 trials for Allogeneic Hematopoietic stem cell transplantation that are still enrolling patients."

Answered by AI

Are we still enrolling patients for this clinical trial?

"This study is not recruiting patients at the moment. According to the date posted and last edited on clinicaltrials.gov, this trial was first introduced on December 8th, 2014. However, there are many other trials seeking leukemia patients (1547) and Allogeneic Hematopoietic Stem Cell Transplantation patients (2173)."

Answered by AI