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Completed

NCT Number: NCT02300961

Feasibility Neurocognitive Outcome After Transplant

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.

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Key information

Conditions

Stem Cell Transplantation Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric Cancer Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive rehabilitation program

Behavioral

Primary outcomes

  1. Number of participants who complete the post-transplant neurocognitive intervention program

    Time frame: 3 months after enrollment

    Number of participants who enroll in and are able to complete the neurocognitive intervention program, measured at 3 months after enrollment.

Secondary outcomes

  1. Number of participants who complete at least half of the neurocognitive intervention program

    Time frame: 3 months after enrollment

    Number of participants who complete at least 50% of scheduled sessions in the neurocognitive intervention program.

  2. Change in WISC-IV or WAIS-IV scores

    Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

    Change in intellectual functioning scores (Full Scale IQ, Verbal Comprehension, Perceptual Reasoning, Working Memory, and Processing Speed indices) from pre-treatment to 1 and 2 years post-treatment.

  3. Change in WRAML-2 scores

    Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

    Change in verbal and visual memory scores from pre-treatment to 1 and 2 years post-treatment using the Wide Range Assessment of Memory and Learning, Second Edition (WRAML-2).

  4. Change in executive functioning scores (D-KEFS or NEPSY-II)

    Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

    Change in executive functioning scores from pre-treatment to 1 and 2 years post-treatment, using Delis Kaplan Executive Function System (D-KEFS; ages 8-21) or NEPSY-II subtests (ages 6-7).

  5. Change in CPT-II scores

    Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

    Change in sustained attention/vigilance scores from pre-treatment to 1 and 2 years post-treatment using Conners' Continuous Performance Test, Second Edition (CPT-II).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2014
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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