NCT03890614

Brief 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 of relapsed hematologic malignancy and potentially other cancers.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
May 2019Feb 2027

First Submitted

Initial submission to the registry

March 18, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 16, 2019

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

7.7 years

First QC Date

March 18, 2019

Last Update Submit

March 17, 2026

Conditions

Hematologic Malignancy

Keywords

3D organoid technique

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Up to 5 days

Secondary Outcomes (3)

  • Number of Reduced Hematologic Malignant Myeloma Cells

    Up to 3 days

  • Comparison of Cell Viability

    24 and 36 hours

  • Organoid Responses Compared to Clinical Response

    Up to 3 months

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hematologic malignancy patients undergoing transplant.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone marrow

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Timothy Pardee, MD, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

3367165772Holly.Maize@Advocatehealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 26, 2019

Study Start

May 16, 2019

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)