Hematopoietic and Lymphoid Cell NeoplasmPhase 2/3NCT03870750
Identifying Best Approach in Improving Quality of Life and Survival After a Donor Stem Cell Transplant in Older, Medically Infirm, or Frail Patients With Blood Diseases
A Phase 2/3 study testing Supportive Palliative Care, Clinical Management and Best Practice in people with Hematopoietic and Lymphoid Cell Neoplasm and Non-Neoplastic Hematologic and Lymphocytic Disorder, run by Fred Hutchinson Cancer Center at 11 sites in United States.
Trial summary
This phase II/III trial studies the best approach in improving quality of life and survival after a donor stem cell transplant in older, weak, or frail patients with blood diseases. Patients who have undergone a transplant often experience increases in disease and death. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Non-Neoplastic Hematologic and Lymphocytic Disorder
- What is being tested?
- Supportive Palliative Care, Clinical Management and Best Practice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 11 sitesUnited States
- Study dates
- 15 Aug 2019to 31 Dec 2025
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vulnerable patients as defined by one or more of the following criteria
- Age 65 years or older
- Having Hematopoietic Cell Transplantation - Comorbidity Index (HCT-CI) scores of >= 3 (for patients that could be 20 years old and older)
- Having frailty as determined by walk speed of < 0.8 m/s using 4-meter walk test (for patients 50 years old and older)
- Patients considered or referred for allogeneic HCT to treat a hematological malignant or non-malignant disease
- Able to speak and read English - interaction with the interventionist trainer and endpoint measurement must occur in English
Show all 10Show fewer
- Willing and able to provide informed consent
- Planned allogeneic HCT within 3 weeks - all types of donors and all sorts of conditioning regimens are allowed. Patients with suspected active disease (relatively old disease staging or relatively old intervention) or significant comorbidity (e.g. suspicious untreated pulmonary nodules) based on prior evaluations, that could delay the transplant would be considered for enrollment within a tighter window (10-14 days before allogeneic HCT) to allow for completed pre-HCT work-up evaluations that would confirm readiness to proceed with transplant
- Able to exercise at low to moderate intensity, specifically taking into consideration the rare circumstances where subjects are not able to exercise due to either birth deformity or prior traumatic injury that affects their gait
- Adequate cardiopulmonary reserve, as judged by data from the patient's electronic medical record as to whether a patient could walk up one flight of stairs, no need for supplemental oxygen, and/or physician judgment
Who cannot join
- Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
- Participation in another intervention clinical trial with HRQOL as a primary endpoint
- Planned donor lymphocyte infusion (DLI) within 90 days post-transplant
- Planned anti-cytotoxic therapies, other than tyrosine kinase inhibitors or single-agent monoclonal antibody, or FLT-3 inhibitors within 90 days of post-transplant unless pre-approved by the protocol principal investigator (PI)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37232
Northwell Health Cancer Institute
New Hyde Park, New York, 11042
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco
San Francisco, California, 94143
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Seamless Phase II-Phase III Randomized Clinical Trial to Identify and Confirm the Most Promising Novel Intervention to Alleviate Morbidity and Mortality After Allogeneic Hematopoietic Cell Transplantation Among Older, Medically Infirm, or Frail Patients With Hematological Diseases
This phase II/III trial studies the best approach in improving quality of life and survival after a donor stem cell transplant in older, weak, or frail patients with blood diseases. Patients who have undergone a transplant often experience increases in disease and death. One approach, supportive and palliative care (SPC), focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects. While a second approach, clinical management of comorbidities (CMC) focuses on managing multiple diseases, other than cancer, such as heart or lung diseases through physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education. Giving SPC, CMC, or a combination of both may work better in improving quality of life and survival after a donor stem cell transplant compared to standard of care in patients with blood diseases.
Read the detailed description
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients undergo SPC on days -15 before to +56 after transplant.
ARM II: Patients undergo a CMC program on days -15 before to +56 after transplant.
ARM III: Patients undergo interventions as outlined in Arm I and Arm II.
ARM IV: Patients receive standard of care.
In all arms, patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment and 30, 90, 180, and 365 days post HCT. In all arms patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Non-Neoplastic Hematologic and Lymphocytic Disorder
- Being tested
- Supportive Palliative Care, Clinical Management, Best Practice, Allogeneic Hematopoietic Stem Cell Transplantation, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Palliative CareOther
Also called Comfort Care, palliation, palliative care, palliative therapy
focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects
Clinical ManagementOther
physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education
Best PracticeOther
Also called standard of care, standard therapy
Given standard of care
Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT
Undergo HCT
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Arm I (SPC) | Experimental | Patients undergo SPC on days -15 before to +56 after transplant. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. Receives: Other: Supportive Palliative Care; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration |
| Arm II (CMC) | Experimental | Patients undergo a CMC program on days -15 to 56. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. Receives: Other: Clinical Management; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration |
| Arm III (SPC and CMC) | Experimental | Patients undergo interventions as outlined in Arm I and Arm II. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. Receives: Other: Supportive Palliative Care; Other: Clinical Management; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration |
| Arm IV (standard of care) | Active comparator | Patients receive standard of care. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. Receives: Other: Best Practice; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in health-related quality of life (HRQOL) (Phase II)
The arm with the largest mean change in Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) from baseline to day 90. The Wilcoxon rank-sum test will be used to compare change in FACT-BMT between arms, and this will also be the test to be used in computation of the conditional power at the end of phase II.
Measured: First 90 days after HCT
Survival after hematopoietic cell transplantation (HCT) (Phase III)
Measured: At 1 year after HCT
Change in HRQOL (Phase III)
Will be measured by the FACT-BMT.
Measured: Baseline to 90 days post-HCT
Secondary outcomes (11)
Rate of overall survival
Overall survival will be compared between each of the experimental arms and the usual care only (UCO) arm using the log-rank test. Arms that do not survive the screening phase will also be included for comparison.
Measured: Up to 1 year
Non-relapse mortality
Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; analysis of variance (ANOVA) or Kruskal-Wallis test for comparisons involving more than two groups). Will use generalized estimating equations (GEEs) approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Measured: At 90 days and up to 1 year
Cumulative incidence of relapse
Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Measured: Up to 1 year
Relapse-free survival
Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Measured: Up to 1 year
Cumulative incidence of frailty
Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Measured: Up to 1 year
Cumulative incidence of disability
Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Measured: Up to 1 year
Frequency of hospitalization
Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Measured: Up to 90 days after HCT
Duration of each hospitalization
Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Measured: Up to 90 days after HCT
Number of admissions to intensive care unit
Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Measured: Up to 90 days after HCT
Duration of admissions to intensive care unit
Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Measured: Up to 90 days after HCT
Days out of hospital alive
Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Measured: Up to 90 days after HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start15 Aug 2019
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: Study terminated due to meeting interim analysis futility endpoint. No difference was found between two treatment arms at interim analysis of primary outcome.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Mohamed Sorror, MD, MSc, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870750
- Sponsor's protocol ID
- RG1004746
- Other IDs
- NCI-2019-01097, 9885, R01CA227092
- Status last verified
- Jan 2026
- First submitted
- 8 Mar 2019
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seamless Phase II-Phase III Randomized Clinical Trial to Identify and Confirm the Most Promising Novel Intervention to Alleviate Morbidity and Mortality After Allogeneic Hematopoietic Cell Transplantation Among Older, Medically Infirm, or Frail Patients With Hematological Diseases
- ClinicalTrials.gov ID
- NCT03870750
- Acronym / sponsor ID
- RG1004746
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Non-Neoplastic Hematologic and Lymphocytic Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to meeting interim analysis futility endpoint. No difference was found between two treatment arms at interim analysis of primary outcome.
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Mar 2019 (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 phase II/III trial studies the best approach in improving quality of life and survival after a donor stem cell transplant in older, weak, or frail patients with blood diseases. Patients who have undergone a transplant often experience increases in disease and death. One approach, supportive and palliative care (SPC), focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects. While a second approach, clinical management of comorbidities (CMC) focuses on managing multiple diseases, other than cancer, such as heart or lung diseases through physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education. Giving SPC, CMC, or a combination of both may work better in improving quality of life and survival after a donor stem cell transplant compared to standard of care in patients with blood diseases.
Detailed description
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients undergo SPC on days -15 before to +56 after transplant.
ARM II: Patients undergo a CMC program on days -15 before to +56 after transplant.
ARM III: Patients undergo interventions as outlined in Arm I and Arm II.
ARM IV: Patients receive standard of care.
In all arms, patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment and 30, 90, 180, and 365 days post HCT. In all arms patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (SPC) | Experimental | Other: Supportive Palliative Care, Procedure: Allogeneic Hematopoietic Stem Cell Transplantation, Other: Questionnaire Administration, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients undergo SPC on days -15 before to +56 after transplant. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. |
| Arm II (CMC) | Experimental | Other: Clinical Management, Procedure: Allogeneic Hematopoietic Stem Cell Transplantation, Other: Questionnaire Administration, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients undergo a CMC program on days -15 to 56. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. |
| Arm III (SPC and CMC) | Experimental | Other: Supportive Palliative Care, Other: Clinical Management, Procedure: Allogeneic Hematopoietic Stem Cell Transplantation, Other: Questionnaire Administration, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients undergo interventions as outlined in Arm I and Arm II. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. |
| Arm IV (standard of care) | Active comparator | Other: Best Practice, Other: Questionnaire Administration, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients receive standard of care. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Vulnerable patients as defined by one or more of the following criteria
- Patients considered or referred for allogeneic HCT to treat a hematological malignant or non-malignant disease
- Able to speak and read English - interaction with the interventionist trainer and endpoint measurement must occur in English
- Willing and able to provide informed consent
- Planned allogeneic HCT within 3 weeks - all types of donors and all sorts of conditioning regimens are allowed. Patients with suspected active disease (relatively old disease staging or relatively old intervention) or significant comorbidity (e.g. suspicious untreated pulmonary nodules) based on prior evaluations, that could delay the transplant would be considered for enrollment within a tighter window (10-14 days before allogeneic HCT) to allow for completed pre-HCT work-up evaluations that would confirm readiness to proceed with transplant
Key exclusion criteria (4 listed)
- Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
- Participation in another intervention clinical trial with HRQOL as a primary endpoint
- Planned donor lymphocyte infusion (DLI) within 90 days post-transplant
- Planned anti-cytotoxic therapies, other than tyrosine kinase inhibitors or single-agent monoclonal antibody, or FLT-3 inhibitors within 90 days of post-transplant unless pre-approved by the protocol principal investigator (PI)
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 |
|---|---|---|
| Supportive Palliative CareAlso: Comfort Care, palliation, palliative care, palliative therapyfocuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects | Other | Arm I (SPC), Arm III (SPC and CMC) |
| Clinical Managementphysical exercise, strength training, stress reduction, medication management, dietary recommendations, and education | Other | Arm II (CMC), Arm III (SPC and CMC) |
| Best PracticeAlso: standard of care, standard therapyGiven standard of care | Other | Arm IV (standard of care) |
| Allogeneic Hematopoietic Stem Cell TransplantationAlso: Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCTUndergo HCT | Procedure or surgery | Arm I (SPC), Arm II (CMC), Arm III (SPC and CMC) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (SPC), Arm II (CMC), Arm III (SPC and CMC), Arm IV (standard of care) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (SPC), Arm II (CMC), Arm III (SPC and CMC), Arm IV (standard of care) |
| Survey AdministrationComplete surveys | Other | Arm I (SPC), Arm II (CMC), Arm III (SPC and CMC), Arm IV (standard of care) |
Primary outcome
Improvement in health-related quality of life (HRQOL) (Phase II)
Time frame: First 90 days after HCT
The arm with the largest mean change in Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) from baseline to day 90. The Wilcoxon rank-sum test will be used to compare change in FACT-BMT between arms, and this will also be the test to be used in computation of the conditional power at the end of phase II.
Survival after hematopoietic cell transplantation (HCT) (Phase III)
Time frame: At 1 year after HCT
Change in HRQOL (Phase III)
Time frame: Baseline to 90 days post-HCT
Will be measured by the FACT-BMT.
11 secondary outcomes
Rate of overall survival
Time frame: Up to 1 year
Non-relapse mortality
Time frame: At 90 days and up to 1 year
Cumulative incidence of relapse
Time frame: Up to 1 year
Relapse-free survival
Time frame: Up to 1 year
Cumulative incidence of frailty
Time frame: Up to 1 year
Cumulative incidence of disability
Time frame: Up to 1 year
Frequency of hospitalization
Time frame: Up to 90 days after HCT
Duration of each hospitalization
Time frame: Up to 90 days after HCT
Number of admissions to intensive care unit
Time frame: Up to 90 days after HCT
Duration of admissions to intensive care unit
Time frame: Up to 90 days after HCT
Days out of hospital alive
Time frame: Up to 90 days after HCT
Results and safety
The study was stopped early (reason given: Study terminated due to meeting interim analysis futility endpoint. No difference was found between two treatment arms at interim analysis of primary outcome.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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.
Mohamed Sorror, MD, MSc principal investigator
Fred Hutch/University of Washington Cancer Consortium
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Supportive Palliative Care, Clinical Management and Best Practice in people with Hematopoietic and Lymphoid Cell Neoplasm and Non-Neoplastic Hematologic and Lymphocytic Disorder, run by Fred Hutchinson Cancer Center at 11 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 10 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: stopped early, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to meeting interim analysis futility endpoint. No difference was found between two treatment arms at interim analysis of primary outcome.). Results are not available in the source record.
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?
Improvement in health-related quality of life (HRQOL) (Phase II) (time frame: First 90 days after HCT). The study lists 3 primary outcomes in all. 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 12 Jan 2026.