Feasibility Neurocognitive Outcome After Transplant

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

A Risk Stratification Model for Neurocognitive Outcome After Transplant and Feasibility of an Early Cognitive Intervention Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02300961
• Other study ID #: IRB-31680
• Secondary ID: PEDSHEM0004
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2014
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: Yi P Wang
• Phone: 650-498-9071
• Email: ywang26[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study will primarily be evaluated by feasibility and adherence to an iPad-based neurocognitive intervention program. It will secondarily be evaluated by performance on the neurocognitive testing post-transplant and change in performance in subsequent years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 21 Years

Eligibility

Inclusion Criteria:

• All patients must have a histologic or cytological diagnosis of ALL treated with stem cell transplantation. There are no restrictions on prior therapy.

• Patients must be between the ages of 6 years and 21 years of age (inclusive), but there will be no discrimination based on gender, race, creed, or ethnic background. The age limits are set at 6 years of age in order to ensure that patients will be able to participate in these specific cognitive rehabilitation tasks. ECOG/KPS will not be employed.

• Patient and/or parents/guardians as appropriate must sign an informed consent, be mentally responsible, able to understand and willing to sign a written informed consent.

Exclusion Criteria:

• Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial. There are no therapy restrictions or restrictions regarding the use of other Investigational Agents.

• Pregnant patients will be excluded.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Pediatric Cancer
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Stem Cell Transplantation

Intervention

Behavioral:
• Cognitive rehabilitation program

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who complete the post-transplant neurocognitive intervention program		26 weeks after transplant