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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days after first infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days after first infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy
Secondary outcome measures
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 • NCT0239385980%
Pyrexia
43%
Nausea
37%
Headache
31%
Vomiting
24%
Anaemia
22%
Diarrhoea
20%
Stomatitis
17%
Mucosal inflammation
13%
Abdominal pain
13%
Rash
13%
Platelet count decreased
13%
Hypertension
11%
Pruritus
11%
Hypokalaemia
11%
Erythema
11%
Hypogammaglobulinaemia
11%
Hypotension
9%
Neutropenia
9%
Tremor
9%
Epistaxis
9%
Constipation
9%
Neutrophil count decreased
7%
Agitation
7%
White blood cell count decreased
7%
Immunodeficiency
7%
Hypervolaemia
7%
Alanine aminotransferase increased
7%
Anal inflammation
7%
Cough
7%
Thrombocytopenia
7%
Abdominal pain upper
7%
Petechiae
7%
Fluid overload
6%
Decreased appetite
6%
Fatigue
6%
Rash maculo-papular
6%
Paronychia
6%
Back pain
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%
Herpes virus infection
2%
Haematoma
2%
Complication associated with device
2%
Engraftment syndrome
2%
Perineal cellulitis
2%
Klebsiella infection
2%
Nervous system disorder
2%
Catheter placement
2%
Oral pain
2%
Accidental overdose
2%
Neurological examination abnormal
2%
Blood immunoglobulin G decreased
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
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
~1210
Methotrexate
2013
Completed Phase 4
~3800
Find a Location
Who is running the clinical trial?
Northside Hospital, Inc.Lead Sponsor
24 Previous Clinical Trials
1,071 Total Patients Enrolled
Melhem Solh, MDPrincipal InvestigatorBlood and Marrow Transplant Group of Georgia
3 Previous Clinical Trials
83 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am starting blinatumomab for my relapsed or MRD-positive B-cell ALL.I do not have any infections or conditions that could affect the study.My acute lymphoblastic leukemia has spread to my brain or spinal cord.I cannot receive methotrexate injections into my spine.My kidney and liver are working well.I have been treated with blinatumomab before.I am able to get out of my bed or chair and move around.I do not have severe brain-related conditions like seizures, stroke, or Parkinson's.I have a cancer diagnosis other than acute lymphoblastic leukemia.
Research Study Groups:
This trial has the following groups:- Group 1: Intrathecal chemotherapy before blinatumomab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Blinatumomab for therapeutic use?
"With the lack of data to support efficacy, Blinatumomab was assigned a safety rating of 2. This score is based on available Phase 2 trial results."
Answered by AI
Is there currently an open call for participants in this clinical investigation?
"As indicated on clinicaltrials.gov, this experiment is not currently accepting new recruits. The trial was initially posted on November 1st 2022 and it's most recent update came out August 29th 2022. Despite the fact that enrollment has temporarily been paused, there are still a multitude of other trials actively searching for volunteers to partake in their studies."
Answered by AI
What goals does this research endeavor seek to fulfill?
"The primary assessment of this trial is the prevalence of neurotoxicity among participants in the first cycle following their initial infusion. Secondary outcomes include complete remission, MRD negativity at the end of cycle 1 (determined by disease restaging assessments such as bone marrow biopsies and lumbar punctures), incidence and grade of cytokine release syndrome during the first cycle, and number of patients that experienced cytokine release syndrome during said period - all evaluated according to CTCAE criteria."
Answered by AI
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