Hematologic MalignancyOrganoidNCT03890614
Novel 3D Hematological Malignancy Organoid to Study Disease Biology and Chemosensitivity
An observational study of Hematologic Malignancy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The objective of this project is to compare chemosensitivity between chemotherapy combinations in bone marrow aspirates using 3D organoid models. The investigators overarching hypothesis is that 3D organoids are ideal to test chemosensitivity in real time, to provide personalized medicine and guidance in the setting… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Ancillary-Correlative - Creation of three-dimensional myeloma organoids using marrow aspirates
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2019to Feb 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hematologic malignancy patients undergoing transplant.
Who may be able to join
- Patients with suspected or confirmed hematologic malignancy undergoing a bone marrow biopsy as part of their care.
- The ability to understand and willingness to sign an IRB approved informed consent document.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Novel 3D Hematological Malignancy Organoid Platform to Study Disease Biology and Perform Chemosensitivity Assays for Patient-Specific Care
The objective of this project is to compare chemosensitivity between chemotherapy combinations in bone marrow aspirates using 3D organoid models. The investigators overarching hypothesis is that 3D organoids are ideal to test chemosensitivity in real time, to provide personalized medicine and guidance in the setting of relapsed hematologic malignancy and potentially other cancers.
Read the detailed description
Optimize the novel 3D organoid technique already used to recreate hematologic tumors.
Optimize cell viability of hematologic cancer organoids to extend available time in culture by screening cell culture media cytokines and 3D extracellular matrix composition.
Evaluate hematologic tumor composition at different time points to confirm accurate tumor representation and identify genetic expression characteristics, unique mutations, and tumor-stroma interaction. These aspects of tumor interaction with its stromal microenviroment will provide critical knowledge to better understand its biology.
Evaluate chemosensitivity on patient derived 3D organoids. Using marrow aspirate from participants with hematologic malignancies, evaluate live/kill rates of hematologic cancer cells after being exposed to established regimen combinations after 24 and 36 hours of exposure at pre-determined concentrations.
Using participant samples, evaluate differences in gene expression and cell markers of the hematologic cancer cells that remained alive after chemotherapy exposure to better understand mechanisms of resistance.
Validate the predictive value of the 3D organoid chemotherapy sensitivity results compared with retrospective data of the donor's responses to the treatment used at that time point. This will compare in vivo/ex vivo responses and facilitate future personalized medicine.
- Conditions
- Hematologic Malignancy
- Being tested
- Ancillary-Correlative - Creation of three-dimensional myeloma organoids using marrow aspirates
- Keywords
- 3D organoid technique
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ancillary-Correlative - Creation of three-dimensional myeloma organoids using marrow aspiratesOther
Bone marrow aspirates will be collected from participants with hematologic malignancy being evaluated for relapsed disease to create three-dimensional constructs using a three-dimensional bioprinting methodology for automated organoid biofabrication.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Live/Dead Myeloma Cells Using Bioprinting Technology
Bone marrow aspirates (around 3-7 ml) will be collected from participants with confirmed or suspected hematologic malignancy being evaluated with a bone marrow biopsy. The samples will be used to create 3D organoid constructs using a 3D bioprinting technology for automated organoid biofabrication using hyaluronic acid and gelatin-based hydrogel. The 3D organoid constructs allow extended time to simulate the protective environment cancer cells use to survive in bone marrow. Organoids will be assessed at 1, 3, and 5 days for viability of myeloma cells. Based on live/dead cells using fluorescent imaging, the hydrogel composition will be modified to allow the optimal media for cell survival ex vivo.
Measured: Up to 5 days
Tumor-Stroma Interactions
To assess the interaction of myeloma cells with stromal cells in a 3D organoid model, plasma and myeloma cells will be labeled using differing colors of Vybrant Multicolor Cell Labeling Kit to allow visualization of the cells' nuceli. By confocal microscope, slides will be evaluated for Vybrant-labeled hematologic malignant cells or healthy plasma cells (different colors) to identify preferential cell interactions. These aspects of tumor interaction with its stromal microenvironment will provide critical knowledge to better understand its biology.
Measured: Up to 5 days
Secondary outcomes (3)
Number of Reduced Hematologic Malignant Myeloma Cells
After 24 hours of incubation, chemotherapy agents will be added at prepared concentrations that fall within the prescribed therapeutic ranges. A maximum of 15 combinations for each donor will be allowed for testing after which the efficacy of the treatments will be assessed qualitatively (live/dead straining) and quantitatively and quantitatively (automated segmentation and quantification of live/dead staining, mitochondrial metabolism/ATP activity, and ratio of Annexin V staining versus Ki67 staining [apoptosis versus proliferation]). These metrics will capture the reduction in hematologic malignant cell population.
Measured: Up to 3 days
Comparison of Cell Viability
Using myeloma patients' marrow aspirate, evaluate live/kill rates of myeloma cells after being exposed to established regimen combinations after 24 and 36 hours of exposure at pre-determined concentrations.
Measured: 24 and 36 hours
Organoid Responses Compared to Clinical Response
The response to each chemotherapy agent from obtained three-dimensional organoids will be compared to actual clinical responses of each participant through retrospective chart review to obtain regimen used to treat disease and the level of measurable disease in serum at different time points of treatment. The time points would include time of marrow biopsy, after 2 cycles of treatment and after 4 cycles of treatment.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start16 May 2019
- 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 Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Timothy Pardee, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890614
- Sponsor's protocol ID
- IRB00057612
- Other IDs
- Crowdcare Foundation, Pilot Fund, P30CA012197, WFBCCC26A19
- Acronym
- Organoid
- Status last verified
- Aug 2026
- First submitted
- 18 Mar 2019
- Last updated
- 6 Aug 2026
- Results posted
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel 3D Hematological Malignancy Organoid Platform to Study Disease Biology and Perform Chemosensitivity Assays for Patient-Specific Care
- ClinicalTrials.gov ID
- NCT03890614
- Acronym / sponsor ID
- Organoid / IRB00057612
- Conditions
- Hematologic Malignancy
- Keywords
- 3D organoid technique
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 May 2019 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 26 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.
The objective of this project is to compare chemosensitivity between chemotherapy combinations in bone marrow aspirates using 3D organoid models. The investigators overarching hypothesis is that 3D organoids are ideal to test chemosensitivity in real time, to provide personalized medicine and guidance in the setting of relapsed hematologic malignancy and potentially other cancers.
Detailed description
Optimize the novel 3D organoid technique already used to recreate hematologic tumors.
Optimize cell viability of hematologic cancer organoids to extend available time in culture by screening cell culture media cytokines and 3D extracellular matrix composition.
Evaluate hematologic tumor composition at different time points to confirm accurate tumor representation and identify genetic expression characteristics, unique mutations, and tumor-stroma interaction. These aspects of tumor interaction with its stromal microenviroment will provide critical knowledge to better understand its biology.
Evaluate chemosensitivity on patient derived 3D organoids. Using marrow aspirate from participants with hematologic malignancies, evaluate live/kill rates of hematologic cancer cells after being exposed to established regimen combinations after 24 and 36 hours of exposure at pre-determined concentrations.
Using participant samples, evaluate differences in gene expression and cell markers of the hematologic cancer cells that remained alive after chemotherapy exposure to better understand mechanisms of resistance.
Validate the predictive value of the 3D organoid chemotherapy sensitivity results compared with retrospective data of the donor's responses to the treatment used at that time point. This will compare in vivo/ex vivo responses and facilitate future personalized medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hematologic malignancy patients undergoing transplant.
Key inclusion criteria (2 listed)
- Patients with suspected or confirmed hematologic malignancy undergoing a bone marrow biopsy as part of their care.
- The ability to understand and willingness to sign an IRB approved informed consent document.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ancillary-Correlative - Creation of three-dimensional myeloma organoids using marrow aspiratesBone marrow aspirates will be collected from participants with hematologic malignancy being evaluated for relapsed disease to create three-dimensional constructs using a three-dimensional bioprinting methodology for automated organoid biofabrication. | Other | – |
Primary outcome
Proportion of Live/Dead Myeloma Cells Using Bioprinting Technology
Time frame: Up to 5 days
Bone marrow aspirates (around 3-7 ml) will be collected from participants with confirmed or suspected hematologic malignancy being evaluated with a bone marrow biopsy. The samples will be used to create 3D organoid constructs using a 3D bioprinting technology for automated organoid biofabrication using hyaluronic acid and gelatin-based hydrogel. The 3D organoid constructs allow extended time to simulate the protective environment cancer cells use to survive in bone marrow. Organoids will be assessed at 1, 3, and 5 days for viability of myeloma cells. Based on live/dead cells using fluorescent imaging, the hydrogel composition will be modified to allow the optimal media for cell survival ex vivo.
Tumor-Stroma Interactions
Time frame: Up to 5 days
To assess the interaction of myeloma cells with stromal cells in a 3D organoid model, plasma and myeloma cells will be labeled using differing colors of Vybrant Multicolor Cell Labeling Kit to allow visualization of the cells' nuceli. By confocal microscope, slides will be evaluated for Vybrant-labeled hematologic malignant cells or healthy plasma cells (different colors) to identify preferential cell interactions. These aspects of tumor interaction with its stromal microenvironment will provide critical knowledge to better understand its biology.
3 secondary outcomes
Number of Reduced Hematologic Malignant Myeloma Cells
Time frame: Up to 3 days
Comparison of Cell Viability
Time frame: 24 and 36 hours
Organoid Responses Compared to Clinical Response
Time frame: Up to 3 months
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 6 Aug 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.
Timothy Pardee, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy, run by Wake Forest University Health Sciences 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 2 inclusion and 0 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 6 Aug 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?
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?
Proportion of Live/Dead Myeloma Cells Using Bioprinting Technology (time frame: Up to 5 days). The study lists 2 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 6 Aug 2026.