Stem Cell TransplantationNCT02300961
Feasibility Neurocognitive Outcome After Transplant
A study testing Cognitive rehabilitation program in people with Stem Cell Transplantation and Pediatric Cancer, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Stem Cell Transplantation, Pediatric Cancer, Acute Lymphoblastic Leukemia
- What is being tested?
- Cognitive rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2014to 3 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: A Risk Stratification Model for Neurocognitive Outcome After Transplant and Feasibility of an Early Cognitive Intervention Program
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.
- Being tested
- Cognitive rehabilitation program
- Medical subject headings
- Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive rehabilitation programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive rehabilitation arm | Experimental | Cognitive rehabilitation program Receives: Behavioral: Cognitive rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete the post-transplant neurocognitive intervention program
Number of participants who enroll in and are able to complete the neurocognitive intervention program, measured at 3 months after enrollment.
Measured: 3 months after enrollment
Secondary outcomes (5)
Number of participants who complete at least half of the neurocognitive intervention program
Number of participants who complete at least 50% of scheduled sessions in the neurocognitive intervention program.
Measured: 3 months after enrollment
Change in WISC-IV or WAIS-IV scores
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.
Measured: Baseline, 1 year post-treatment, 2 years post-treatment
Change in WRAML-2 scores
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).
Measured: Baseline, 1 year post-treatment, 2 years post-treatment
Change in executive functioning scores (D-KEFS or NEPSY-II)
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).
Measured: Baseline, 1 year post-treatment, 2 years post-treatment
Change in CPT-II scores
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).
Measured: Baseline, 1 year post-treatment, 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study start1 Dec 2014
- Primary completion3 Feb 2024
- Study completion3 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Susan Hiniker, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300961
- Sponsor's protocol ID
- IRB-31680
- Other IDs
- NCI-2014-02434
- Status last verified
- May 2026
- First submitted
- 21 Nov 2014
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Risk Stratification Model for Neurocognitive Outcome After Transplant and Feasibility of an Early Cognitive Intervention Program
- ClinicalTrials.gov ID
- NCT02300961
- Acronym / sponsor ID
- IRB-31680
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 3 Feb 2024 (actual)
- Study completion
- 3 Feb 2024 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive rehabilitation arm | Experimental | Behavioral: Cognitive rehabilitation programCognitive rehabilitation program |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive rehabilitation program | Behavioural | Cognitive rehabilitation arm |
Primary outcome
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.
5 secondary outcomes
Number of participants who complete at least half of the neurocognitive intervention program
Time frame: 3 months after enrollment
Change in WISC-IV or WAIS-IV scores
Time frame: Baseline, 1 year post-treatment, 2 years post-treatment
Change in WRAML-2 scores
Time frame: Baseline, 1 year post-treatment, 2 years post-treatment
Change in executive functioning scores (D-KEFS or NEPSY-II)
Time frame: Baseline, 1 year post-treatment, 2 years post-treatment
Change in CPT-II scores
Time frame: Baseline, 1 year post-treatment, 2 years post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Hiniker, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive rehabilitation program in people with Stem Cell Transplantation and Pediatric Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete the post-transplant neurocognitive intervention program (time frame: 3 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.