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BiTE Antibody

Intrathecal Chemoprophylaxis for Acute Lymphoblastic Leukemia

Phase 2
Recruiting
Led By Melhem Solh, MD
Research Sponsored by Northside Hospital, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days after first infusion
Awards & highlights
No Placebo-Only Group

Summary

This trial found that changing the schedule of how intrathecal chemotherapy and blinatumomab are given can help limit the neurotoxicity associated with cytokine release.

Who is the study for?
Adults with B-cell Acute Lymphoblastic Leukemia who are about to start their first cycle of blinatumomab can join. They must have good kidney and liver function, be HIV negative, not pregnant if applicable, and without active infections or other serious health issues that could interfere with the study.
What is being tested?
The trial is testing a new schedule for giving intrathecal chemotherapy (directly into the spinal fluid) alongside blinatumomab to see if it reduces brain-related side effects while still fighting leukemia effectively.
What are the potential side effects?
Possible side effects include those related to methotrexate such as headache, back pain, nausea, vomiting; and from blinatumomab like fever, fatigue, headache. Neurotoxicity symptoms like confusion or seizures may also occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days after first infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days after first infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy
Secondary study objectives
Number of participants that experienced cytokine release syndrome during the first cycle of blinatumomab therapy
Number of participants with a response of complete remission and MRD negativity at the end of cycle 1

Side effects data

From 2022 Phase 3 trial • 111 Patients • NCT02393859
80%
Pyrexia
43%
Nausea
37%
Headache
31%
Vomiting
24%
Anaemia
22%
Diarrhoea
20%
Stomatitis
17%
Mucosal inflammation
13%
Abdominal pain
13%
Platelet count decreased
13%
Rash
13%
Hypertension
11%
Pruritus
11%
Erythema
11%
Hypokalaemia
11%
Hypogammaglobulinaemia
11%
Hypotension
9%
Tremor
9%
Neutropenia
9%
Epistaxis
9%
Constipation
9%
Neutrophil count decreased
7%
Immunodeficiency
7%
White blood cell count decreased
7%
Agitation
7%
Alanine aminotransferase increased
7%
Hypervolaemia
7%
Anal inflammation
7%
Cough
7%
Thrombocytopenia
7%
Abdominal pain upper
7%
Petechiae
7%
Fluid overload
6%
Paronychia
6%
Rash maculo-papular
6%
Back pain
6%
Fatigue
6%
Decreased appetite
6%
Nasopharyngitis
6%
Febrile neutropenia
6%
Urticaria
4%
Fluid balance positive
4%
Seizure
4%
Oropharyngeal pain
4%
Aplasia
4%
Pain in extremity
4%
Neurological symptom
4%
Aspartate aminotransferase increased
2%
Nervous system disorder
2%
Oral pain
2%
Perineal cellulitis
2%
Haematoma
2%
Herpes virus infection
2%
Klebsiella infection
2%
Engraftment syndrome
2%
Blood immunoglobulin G decreased
2%
Complication associated with device
2%
Accidental overdose
2%
Neurological examination abnormal
2%
Catheter placement
2%
Antithrombin III decreased
2%
Laryngotracheitis obstructive
2%
Pain
2%
Hypertransaminasaemia
2%
Rhinitis
2%
Body temperature increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Blinatumomab
HC3 Chemotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intrathecal chemotherapy before blinatumomabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1230
Methotrexate
2019
Completed Phase 4
~4400

Find a Location

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor
24 Previous Clinical Trials
1,048 Total Patients Enrolled
Melhem Solh, MDPrincipal InvestigatorBlood and Marrow Transplant Group of Georgia
3 Previous Clinical Trials
83 Total Patients Enrolled

Media Library

Blinatumomab (BiTE Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT05519579 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Intrathecal chemotherapy before blinatumomab
Acute Lymphoblastic Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT05519579 — Phase 2
Blinatumomab (BiTE Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05519579 — Phase 2
~9 spots leftby Nov 2025
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