Central Nervous System LymphomaNCT05011045
Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies
An observational study of Central Nervous System Lymphoma and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study assesses neurocognitive outcomes after receiving radiation therapy to the brain (whole brain radiation therapy) in patients with blood cancers (hematologic malignancies). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Lymphoma, Hematopoietic and Lymphoid Cell Neoplasm, Leukemia
- What is being tested?
- Magnetic Resonance Imaging, Neurocognitive Assessment and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 31 Oct 2026
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with radiation therapy to the brain for a hematologic malignancies
Who may be able to join
- Age 18 years or older
- Treatment with radiation therapy to the brain for a hematologic malignancy (ex. primary central nervous system lymphoma [PCNSL], secondary central nervous system lymphoma [SCNSL], leukemia, myeloma)
- Proficient and capable of completing tests in English
- Patients with claustrophobia are eligible if the claustrophobia is managed with medication
- Patients with cognitively-impairment are eligible if the impairment is managed with medication
- Patients who are pregnant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Dustin M. Silk, 713-563-3090, dmsilk@mdanderson.org
Bouthaina S. Dabaja
About this study
This study assesses neurocognitive outcomes after receiving radiation therapy to the brain (whole brain radiation therapy) in patients with blood cancers (hematologic malignancies). This may help researchers learn more about the effects of whole brain radiation therapy on memory and thinking in patients with blood cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Record patients' cognitive outcomes after whole-brain radiation therapy (WBRT) for hematologic malignancies using standard-of-care neurocognitive function testing.
SECONDARY OBJECTIVES:
- Assess patients' quality-of-life after WBRT for hematologic malignancies, based on a validated questionnaire.
II. Explore magnetic resonance imaging (MRI) changes in the brain after WBRT for hematologic malignancies, based on standard-of-care imaging studies.
III. Study the role of Memantine in patients' cognitive outcomes during and after WBRT for hematologic malignancies, based on standard-of-care use, utilizing standard-of-care neurocognitive function testing.
OUTLINE:
Patients undergo neurocognitive function assessments, complete questionnaires over 8-10 minutes and undergo standard of care MRI at baseline (within 4 weeks before the first day of WBRT), 2, 6, 12 months after RT completion, then annually for 5 years.
- Conditions
- Central Nervous System Lymphoma, Hematopoietic and Lymphoid Cell Neoplasm, Leukemia, Lymphoma, Plasma Cell Myeloma, Secondary Central Nervous System Lymphoma
- Being tested
- Magnetic Resonance Imaging, Neurocognitive Assessment, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo MRI
Neurocognitive AssessmentOther
Undergo neurocognitive function assessment
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete questionnaires
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (neurocognitive assessment, questionnaires, MRI) | Patients undergo neurocognitive function assessments, complete questionnaires over 8-10 minutes and undergo standard of care MRI at baseline (within 4 weeks before the first day of WBRT), 2, 6, 12 months after RT completion, then annually for 5 years. Receives: Procedure: Magnetic Resonance Imaging; Other: Neurocognitive Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive outcomes
Neurocognitive failure will be defined as the first cognitive failure on 2 or more of the following tests: the Hopkins Verbal Learning Test Revised Total Recall, Delayed Recall and Delayed Recognition; the Controlled Oral Word Association; and the Trail Making Test Part A or B. The rate of neurocognitive failure and its 95% confidence interval (CI) will be calculated. The cumulative incidence approach may be used to estimate the median time to neurocognitive failure to account for the competing risk of death. May use the Aalen-Johansen estimator of the cumulative incidence function.
Measured: Up to 5 years
Secondary outcomes (3)
Quality-of-life
Assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30/Brain Neoplasm 20. The rates of improvement and worsening will be calculated. The rate of deterioration will be calculated. Also, Wilcoxon signed rank test or paired t-test will be used to compare the scores between baseline and after radiation at 2 months.
Measured: Up to 5 years
Magnetic resonance imaging (MRI) changes
Will explore radiographic changes on standard-of-care MRI scans that are suggestive of radiation toxicity. Radiographic changes will be considered in the context of radiation treatment plans. Correlation of radiographic changes with radiation dose will be performed for hypothesis generation. Spearman correlation coefficient may be used to assess the correlation between radiographic changes and radiation dose.
Measured: Baseline up to 5 years
Role of medications indicated to improve memory and cognitive function
Neurocognitive outcomes at different time points will be summarized using descriptive statistics. Changes overtime on neurocognitive outcomes may be analyzed using generalized linear models for the repeated measures. May compare the neurocognitive outcomes of the patients to a similar cohort of patients that were not treated with Memantine or other medications indicated to improve memory and cognitive function (example the RT arm of RTOG 1114). Will amend the protocol to include the details on which cohort of patients to be compared to, variables to be used for matching the two patient cohorts, and method to be used for matching once decided to proceed with the comparison.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start9 Jan 2020
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bouthaina S Dabaja, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011045
- Sponsor's protocol ID
- PA18-0791
- Other IDs
- PA18-0791, NCI-2021-08429
- Status last verified
- May 2026
- First submitted
- 12 Aug 2021
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No