Acute Lymphoblastic LeukemiaNCT05972577
Geriatric Optimization Plan to Improve Survival in Older Adult Allogeneic Hematopoietic Cell Transplant Candidates, OTIS Study
A study testing Health Promotion and Education, Medical Device Usage and Evaluation and Quality-of-Life Assessment in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial tests whether a geriatric optimization plan (GO!) works to improve survival in patients over 60 with a hematologic malignancy or bone marrow failure syndrome eligible for allogeneic hematopoietic cell transplant. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aplastic Anemia
- What is being tested?
- Health Promotion and Education, Medical Device Usage and Evaluation and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 13 Nov 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 60 years
- Diagnosed with hematologic malignancy or bone marrow failure syndrome eligible for allogeneic hematopoietic cell transplantation. This includes acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myelofibrosis, chronic myeloid leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma, and aplastic anemia. Disease specific eligibility for allo-HCT to be determined by treating physician
- Must be able to understand written and spoken English
- Must be willing to attend all study visits and comply with study procedures for the entire length of the study
Who cannot join
- Documented history of dementia
- No possibility of proceeding to allogeneic hematopoietic cell transplant within the next 6 months as determined by treating physician
- Scheduled admission for allogeneic hematopoietic cell transplant within 30 days of enrollment
- Inability or unwillingness to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Optimization of Older Adult Allogeneic Hematopoietic Cell Transplant Candidates to Improve Survival (OTIS)
This clinical trial tests whether a geriatric optimization plan (GO!) works to improve survival in patients over 60 with a hematologic malignancy or bone marrow failure syndrome eligible for allogeneic hematopoietic cell transplant. GO! focuses on creating a tailored and specific plan for each patient to make changes in their daily lives. These may include changes to their diet, sleep, activity, medicines, or even referrals to other providers depending on the patient's needs. Studying survival and quality of life in patients over 60 receiving an allogeneic hematopoietic cell transplant may help identify the effects of treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To demonstrate that geriatric assessment with management (GAM) intervention will lead to improved physical functioning in allogeneic hematopoietic cell transplant (allo-HCT)-eligible older adults as measured by improvement in 6-Minute Walk Test distance of at least 35 meters.
SECONDARY OBJECTIVES:
- To demonstrate that GAM intervention will result in improvement in Short Physical Performance Battery score by at least 1 point or score will remain >= 10 for those with baseline scores >= 10.
II. To demonstrate that GAM intervention will result in improvement in Mini Nutritional Assessment score by at least 2 points or score will remain >= 12 for those with baseline scores >= 12.
III. To evaluate change in cognition and mental health as measured by Montreal Cognitive Assessment, Personal Health Questionnaire-9, Generalized Anxiety Disorder-7, and Transplant Evaluation Rating Scale score before and after GAM intervention.
IV. To determine cumulative incidence rate for receipt of allo-HCT among study participants.
- To measure overall survival and non-relapse mortality among study participants.
VI. To assess self-reported adherence to prescribed interventions. VII. To measure change in patient-reported quality of life immediately following GAM intervention and up to one year after completion of intervention.
EXPLORATORY OBJECTIVES:
- To describe patterns of sleep and activity among study participants during intervention period based on accelerometer data.
II. To understand transplant physician rationale for not proceeding to allo-HCT for older patients with eligible diagnoses.
OUTLINE:
Patients undergo personalized Geriatric Optimization (GO!) plan consisting of study visits over 50 minutes at baseline and 6 months after first visit or at the time of hospital admission for bone marrow transplant and over 25 minutes at 3 and 12 months after transplant. Patients complete questionnaires once a month for up to 6 months and wear an accelerometer for up to 6 months.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aplastic Anemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- Health Promotion and Education, Medical Device Usage and Evaluation, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Anemia, Aplastic, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hematologic Neoplasms, Hodgkin Disease, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Promotion and EducationOther
Undergo GO!
Medical Device Usage and EvaluationOther
Wear accelerometer
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality of life assessments and diary entries
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (GO!) | Experimental | Patients undergo personalized GO! plan consisting of study visits over 50 minutes at baseline and 6 months after first visit or at the time of hospital admission for bone marrow transplant and over 25 minutes at 3 and 12 months after transplant. Patients complete questionnaires once a month for up to 6 months and wear an accelerometer for up to 6 months. Receives: Other: Health Promotion and Education; Other: Medical Device Usage and Evaluation; 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.
Change in 6-Minute Walk Test distance
Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Measured: At 6 months before transplant, up to 12 months after transplant
Secondary outcomes (12)
Change in Short Physical Performance Battery score
Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Measured: At 6 months before transplant, up to 12 months after transplant
Change in in Mini Nutritional Assessment score
Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Measured: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Measured by Montreal Cognitive Assessment Generalized Anxiety Disorder-7. Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Measured: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Measured by Personal Health Questionnaire-9. Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Measured: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Measured by Generalized Anxiety Disorder-7. Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Measured: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Measured by Transplant Evaluation Rating scale score. Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Measured: At 6 months before transplant, up to 12 months after transplant
Proportion of sample achieving "normal" scores on geriatric assessment tools
McNemar test will be used to compare proportion of sample achieving normal scores on geriatric assessment tools.
Measured: At 6 months before transplant, up to 12 months after transplant
Time to receipt of transplant
Estimates of cumulative incidence of receipt of transplant with 95% confidence intervals will be provided for 100 days and one-year after end of treatment.
Measured: Up to 1 year after treatment
Overall survival
Overall survival will be defined as the period from date of baseline assessment to death from any cause. Date of death will be confirmed by chart review. Will be estimated utilizing Kaplan-Meier method.
Measured: Up to 12 months after transplant
Non-relapse mortality
Non-relapse mortality will be defined as the period from date of baseline assessment to death without evidence of relapsed primary hematologic disease. Relapse will be treated as competing risk. Documentation of date of relapse will be confirmed by chart review and collaboration with transplant physician if necessary. Estimates of cumulative incidence of non-relapse mortality with 95% confidence intervals will be provided for 100 days and one-year after end of treatment.
Measured: Up to 12 months after transplant
Adherence to prescribed geriatric optimization plan (GO!) prescription
Will be assessed by self-report through monthly survey during intervention and at end-of-treatment assessment. Participants will be asked to estimate monthly frequency of completing all items in GO! prescription and this information will be collected through REDCap survey. Due to self-report nature of this item, no specific definition of adherence is offered beyond that which is asked of participants.
Measured: Up to 6 months after transplant
Change in quality of life
Assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Elderly Cancer Patients Module. Wilcoxon signed rank test or McNemar test will be used to assess the change over time.
Measured: At 6 months before transplant, 3, and 6 month after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start11 Jun 2021
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Wall, Ohio State University Comprehensive Cancer Center
- Investigators
- Sarah Wall, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972577
- Sponsor's protocol ID
- OSU-21010
- Other IDs
- NCI-2021-10004
- Status last verified
- Mar 2026
- First submitted
- 13 Jul 2022
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Older Adult Allogeneic Hematopoietic Cell Transplant Candidates to Improve Survival (OTIS)
- ClinicalTrials.gov ID
- NCT05972577
- Acronym / sponsor ID
- OSU-21010
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aplastic Anemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid Cell Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 2 Aug 2023 (actual)
- 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 clinical trial tests whether a geriatric optimization plan (GO!) works to improve survival in patients over 60 with a hematologic malignancy or bone marrow failure syndrome eligible for allogeneic hematopoietic cell transplant. GO! focuses on creating a tailored and specific plan for each patient to make changes in their daily lives. These may include changes to their diet, sleep, activity, medicines, or even referrals to other providers depending on the patient's needs. Studying survival and quality of life in patients over 60 receiving an allogeneic hematopoietic cell transplant may help identify the effects of treatment.
Detailed description
PRIMARY OBJECTIVE:
- To demonstrate that geriatric assessment with management (GAM) intervention will lead to improved physical functioning in allogeneic hematopoietic cell transplant (allo-HCT)-eligible older adults as measured by improvement in 6-Minute Walk Test distance of at least 35 meters.
SECONDARY OBJECTIVES:
- To demonstrate that GAM intervention will result in improvement in Short Physical Performance Battery score by at least 1 point or score will remain >= 10 for those with baseline scores >= 10.
II. To demonstrate that GAM intervention will result in improvement in Mini Nutritional Assessment score by at least 2 points or score will remain >= 12 for those with baseline scores >= 12.
III. To evaluate change in cognition and mental health as measured by Montreal Cognitive Assessment, Personal Health Questionnaire-9, Generalized Anxiety Disorder-7, and Transplant Evaluation Rating Scale score before and after GAM intervention.
IV. To determine cumulative incidence rate for receipt of allo-HCT among study participants.
- To measure overall survival and non-relapse mortality among study participants.
VI. To assess self-reported adherence to prescribed interventions. VII. To measure change in patient-reported quality of life immediately following GAM intervention and up to one year after completion of intervention.
EXPLORATORY OBJECTIVES:
- To describe patterns of sleep and activity among study participants during intervention period based on accelerometer data.
II. To understand transplant physician rationale for not proceeding to allo-HCT for older patients with eligible diagnoses.
OUTLINE:
Patients undergo personalized Geriatric Optimization (GO!) plan consisting of study visits over 50 minutes at baseline and 6 months after first visit or at the time of hospital admission for bone marrow transplant and over 25 minutes at 3 and 12 months after transplant. Patients complete questionnaires once a month for up to 6 months and wear an accelerometer for up to 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (GO!) | Experimental | Other: Health Promotion and Education, Other: Medical Device Usage and Evaluation, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo personalized GO! plan consisting of study visits over 50 minutes at baseline and 6 months after first visit or at the time of hospital admission for bone marrow transplant and over 25 minutes at 3 and 12 months after transplant. Patients complete questionnaires once a month for up to 6 months and wear an accelerometer for up to 6 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 60 years
- Diagnosed with hematologic malignancy or bone marrow failure syndrome eligible for allogeneic hematopoietic cell transplantation. This includes acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myelofibrosis, chronic myeloid leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma, and aplastic anemia. Disease specific eligibility for allo-HCT to be determined by treating physician
- Must be able to understand written and spoken English
- Must be willing to attend all study visits and comply with study procedures for the entire length of the study
Key exclusion criteria (4 listed)
- Documented history of dementia
- No possibility of proceeding to allogeneic hematopoietic cell transplant within the next 6 months as determined by treating physician
- Scheduled admission for allogeneic hematopoietic cell transplant within 30 days of enrollment
- Inability or unwillingness to give written informed consent
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 |
|---|---|---|
| Health Promotion and EducationUndergo GO! | Other | Supportive care (GO!) |
| Medical Device Usage and EvaluationWear accelerometer | Other | Supportive care (GO!) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete quality of life assessments and diary entries | Other | Supportive care (GO!) |
| Questionnaire AdministrationComplete questionnaires | Other | Supportive care (GO!) |
Primary outcome
Change in 6-Minute Walk Test distance
Time frame: At 6 months before transplant, up to 12 months after transplant
Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
12 secondary outcomes
Change in Short Physical Performance Battery score
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in in Mini Nutritional Assessment score
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Time frame: At 6 months before transplant, up to 12 months after transplant
Proportion of sample achieving "normal" scores on geriatric assessment tools
Time frame: At 6 months before transplant, up to 12 months after transplant
Time to receipt of transplant
Time frame: Up to 1 year after treatment
Overall survival
Time frame: Up to 12 months after transplant
Non-relapse mortality
Time frame: Up to 12 months after transplant
Adherence to prescribed geriatric optimization plan (GO!) prescription
Time frame: Up to 6 months after transplant
Change in quality of life
Time frame: At 6 months before transplant, 3, and 6 month after transplant
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 6 Apr 2026.
- The JameslineLink provided by the sponsor.
- 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.
Sarah Wall, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Promotion and Education, Medical Device Usage and Evaluation and Quality-of-Life Assessment in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by Ohio State University Comprehensive Cancer Center 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 4 inclusion and 4 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 6 Apr 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?
Change in 6-Minute Walk Test distance (time frame: At 6 months before transplant, up to 12 months after transplant). 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 6 Apr 2026.