RECRUITING

Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release.

Official Title

Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

Quick Facts

Study Start:2023-06-30

Study Completion:2025-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05519579

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia * Adequate renal and hepatic function * Negative for HIV * Negative serum pregnancy test, if applicable * ECOG 0-2	* Active CNS involvement by ALL * Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder) * Contraindication to receive intrathecal methotrexate * Prior treatment with blinatumomab * Active malignancy other than ALL * Active infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator

Inclusion Criteria

Exclusion Criteria

* Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia
* Adequate renal and hepatic function
* Negative for HIV
* Negative serum pregnancy test, if applicable
* ECOG 0-2

* Active CNS involvement by ALL
* Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder)
* Contraindication to receive intrathecal methotrexate
* Prior treatment with blinatumomab
* Active malignancy other than ALL
* Active infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator

Contacts and Locations

Study Contact

Caitlin Guzowski

CONTACT

404-851-8523

caitlin.guzowski@northside.com

Principal Investigator

Melhem Solh, MD

PRINCIPAL_INVESTIGATOR

Blood and Marrow Transplant Group of Georgia

Study Locations (Sites)

Northside Hospital

Atlanta, Georgia, 30342

United States

Collaborators and Investigators

Sponsor: Northside Hospital, Inc.

Melhem Solh, MD, PRINCIPAL_INVESTIGATOR, Blood and Marrow Transplant Group of Georgia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-30

Study Completion Date2025-08-01

Study Record Updates

Study Start Date2023-06-30

Study Completion Date2025-08-01

Terms related to this study

Additional Relevant MeSH Terms

Acute Lymphoblastic Leukemia