Myelodysplastic SyndromePhase 2NCT04761770
Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders
A Phase 2 study testing Geriatric assessment (GA) pre-transplant, conditioning regimen and Allogeneic CD34+ selected stem cells in people with Myelodysplastic Syndrome and Myeloproliferative Neoplasms, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
This study will evaluate whether a geriatric assessment can lead to better treatment outcomes in older patients (age 60+) with a myeloid malignancy including acute myeloid leukemia, ,myelodysplastic syndromes, myeloproliferative neoplasms, or related blood disorders who are going to receive chemotherapy or another… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia
- What is being tested?
- Geriatric assessment (GA) pre-transplant, conditioning regimen and Allogeneic CD34+ selected stem cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Feb 2021to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- are 60 years or older
- have a pathologically confirmed myeloid malignancies including acute myeloid leukemia, ,myelodysplastic syndrome, myeloproliferative neoplasms, or related blood disorders including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, and myelodysplastic/myeloproliferative overlapping syndrome
- have <10% blasts in bone marrow prior to transplant
- have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor
- Meet institutional standard criteria for allogeneic transplantation as determined by the primary transplant physician
- Undergoes transplantation using the allocated conditioning regimen intensity defined by the protocol-specified criteria below:
- HCT-CI/Age <5 and IADL normal = myeloablative regimen
- HCT-CI/Age ≥5 and/or IADL impairment = RIC/NMA regimen
Who cannot join
- Prior hematopoietic cell transplantation
- Cord blood donors
- Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553
About this study
Official title: Phase II Study of a Geriatric Assessment-Driven, Risk-Adapted Allogeneic Hematopoietic Cell Transplant Strategy for Older Patients With Myeloid Malignancies
This study will evaluate whether a geriatric assessment can lead to better treatment outcomes in older patients (age 60+) with a myeloid malignancy including acute myeloid leukemia, ,myelodysplastic syndromes, myeloproliferative neoplasms, or related blood disorders who are going to receive chemotherapy or another treatment to prepare the body for an allogeneic hematopoietic stem cell transplant (allo-HCT). The geriatric assessment includes looking at patients' cognitive function (thinking processes), physical function, mobility (ability to move the body), mood, nutrition, and current medications to help decide the type of treatment they'll receive.
Another purpose of this study is to see whether use of the geriatric assessment improves participants' quality of life. We will evaluate participants' quality of life through questionnaires.
Read the detailed description
This is a prospective, phase II study evaluating the efficacy of a risk-adapted, personalized allo-HCT strategy based on geriatric vulnerabilities identified by pre-transplant GA. The less vulnerable/fit older patients are recommended to receive MA conditioning and the more vulnerable older patients are recommended to receive RIC/NMA conditioning.
- HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> MA regimen
- HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> RIC/NMA regimen
- Chemotherapies: busulfan, fludarabine, melphalan, cyclophosphamide, thiotepa, clofarabine
- Radiation therapy: total body irradiation (TBI)
- Other therapy: anti-thymocyte globulin (ATG)
- Conditions
- Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia, Atypical Chronic Myeloid Leukemia, Myelodysplastic/Myeloproliferative Overlapping Syndrome
- Being tested
- Geriatric assessment (GA) pre-transplant, conditioning regimen, Allogeneic CD34+ selected stem cells
- Keywords
- blood disorders, Allogeneic Hematopoietic Cell Transplant, 20-522
- Medical subject headings
- Myelodysplastic Syndromes, Myeloproliferative Disorders, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric assessment (GA) pre-transplantOther
Assessment of comorbidities, polypharmacy, and functional, nutritional, and psychosocial impairment.
conditioning regimenDrug
Based on the Geriatric assessment.
- HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> Myeloablative (MA) regimen
- HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> Reduced-intensity (RIC)/Nonmyeloablative (NMA) regimen
Allogeneic CD34+ selected stem cellsProcedure or surgery
Stem cells are collected as per institutional guidelines. CD34+ enriched stem cells will be obtained using the FDA approved reagents from Miltenyi, according to the instruction manual.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric participants with various blood disorders | Experimental | 1. Geriatric assessment (GA) pre-transplant
2. Risk-adapted allocation of conditioning intensity based on GA
3. GA-directed, longitudinal supportive care management Receives: Other: Geriatric assessment (GA) pre-transplant; Drug: conditioning regimen; Procedure: Allogeneic CD34+ selected stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence of non-relapse mortality (NRM)
defined as death in the absence of relapse/disease progression.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start15 Feb 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single center, phase II pilot treatment-allocation study at MSK for older patients considering allogeneic hematopoietic cell transplantation.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard J Lin, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761770
- Sponsor's protocol ID
- 20-522
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of a Geriatric Assessment-Driven, Risk-Adapted Allogeneic Hematopoietic Cell Transplant Strategy for Older Patients With Myeloid Malignancies
- ClinicalTrials.gov ID
- NCT04761770
- Acronym / sponsor ID
- 20-522
- Conditions
- Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia, Atypical Chronic Myeloid Leukemia, Myelodysplastic/Myeloproliferative Overlapping Syndrome
- Keywords
- blood disorders, Allogeneic Hematopoietic Cell Transplant, 20-522
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Feb 2021 (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 study will evaluate whether a geriatric assessment can lead to better treatment outcomes in older patients (age 60+) with a myeloid malignancy including acute myeloid leukemia, ,myelodysplastic syndromes, myeloproliferative neoplasms, or related blood disorders who are going to receive chemotherapy or another treatment to prepare the body for an allogeneic hematopoietic stem cell transplant (allo-HCT). The geriatric assessment includes looking at patients' cognitive function (thinking processes), physical function, mobility (ability to move the body), mood, nutrition, and current medications to help decide the type of treatment they'll receive.
Another purpose of this study is to see whether use of the geriatric assessment improves participants' quality of life. We will evaluate participants' quality of life through questionnaires.
Detailed description
This is a prospective, phase II study evaluating the efficacy of a risk-adapted, personalized allo-HCT strategy based on geriatric vulnerabilities identified by pre-transplant GA. The less vulnerable/fit older patients are recommended to receive MA conditioning and the more vulnerable older patients are recommended to receive RIC/NMA conditioning.
- HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> MA regimen
- HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> RIC/NMA regimen
- Chemotherapies: busulfan, fludarabine, melphalan, cyclophosphamide, thiotepa, clofarabine
- Radiation therapy: total body irradiation (TBI)
- Other therapy: anti-thymocyte globulin (ATG)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single center, phase II pilot treatment-allocation study at MSK for older patients considering allogeneic hematopoietic cell transplantation.
| Arm | Type | Receives |
|---|---|---|
| Geriatric participants with various blood disorders | Experimental | Other: Geriatric assessment (GA) pre-transplant, Drug: conditioning regimen, Procedure: Allogeneic CD34+ selected stem cells1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- are 60 years or older
- have a pathologically confirmed myeloid malignancies including acute myeloid leukemia, ,myelodysplastic syndrome, myeloproliferative neoplasms, or related blood disorders including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, and myelodysplastic/myeloproliferative overlapping syndrome
- have <10% blasts in bone marrow prior to transplant
- have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor
- Meet institutional standard criteria for allogeneic transplantation as determined by the primary transplant physician
Key exclusion criteria (3 listed)
- Prior hematopoietic cell transplantation
- Cord blood donors
- Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant
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 |
|---|---|---|
| Geriatric assessment (GA) pre-transplantAssessment of comorbidities, polypharmacy, and functional, nutritional, and psychosocial impairment. | Other | Geriatric participants with various blood disorders |
| conditioning regimenBased on the Geriatric assessment. 1. HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> Myeloablative (MA) regimen 2. HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> Reduced-intensity (RIC)/Nonmyeloablative (NMA) regimen | Drug | Geriatric participants with various blood disorders |
| Allogeneic CD34+ selected stem cellsStem cells are collected as per institutional guidelines. CD34+ enriched stem cells will be obtained using the FDA approved reagents from Miltenyi, according to the instruction manual. | Procedure or surgery | Geriatric participants with various blood disorders |
Primary outcome
cumulative incidence of non-relapse mortality (NRM)
Time frame: 1 year
defined as death in the absence of relapse/disease progression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Richard J Lin, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Geriatric assessment (GA) pre-transplant, conditioning regimen and Allogeneic CD34+ selected stem cells in people with Myelodysplastic Syndrome and Myeloproliferative Neoplasms, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 8 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
cumulative incidence of non-relapse mortality (NRM) (time frame: 1 year). 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 17 Feb 2026.