Trial · NCT03399773
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes
NCT03399773, Phase 2, Active not recruiting, Fred Hutchinson Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes. Trials, record NCT03399773. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03399773
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes
- NCT number
- NCT03399773
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid Cell Neoplasm, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts
- Interventions
Dilanubicel, Cyclophosphamide, Fludarabine, Thiotepa, Total-Body Irradiation, Umbilical Cord Blood Transplantation, Laboratory Biomarker Analysis, Biospecimen Collection, Bone Marrow Aspirate, Bone Marrow Biopsy, Multigated Acquisition Scan, Electrocardiography, Computed Tomography
- First posted
- 2018-01-16
- Last updated
- 2026-07-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Graft Failure | Up to day 45 post-transplant | Primary graft failure/rejection as defined by no neutrophil recovery (regardless of donor chimerism) or autologous recovery (neutrophil recovery but \< 10% donor chimerism in blood and bone marrow \[BM\]). |
| Secondary | Number of Participants Who Experienced Grade ≥3 Adverse Events Related to Study Product | From study product infusion start through day 100 post-transplant | Adverse events (AEs) were graded using the CTCAE v5.0. This outcome measured the number of participants who experienced at least one grade ≥ 3 adverse event considered related to the study product during the period of start of infusion of the study product (Day 0) until 100 days following transplant. An AE is considered related to the study product based on investigator assessment if it was assessed as definitely, probably, or possibly related; unrelated if it is assessed as unlikely related or unrelated. AE severity grade, seriousness, and relatedness were evaluated independently; therefore, grade ≥3 events were not necessarily serious adverse events (SAEs). Reporting of grade ≥3 AEs and all-grade SAEs is provided in the Adverse Events module. Dose-limiting toxicities (DLTs) were predefined. |
| Secondary | Time to Neutrophil Engraftment | Up to day 45 post-transplant | The day of neutrophil recovery will be the 1st day of 2 consecutive days of absolute neutrophil count at or above 500 after the 1st post-cord blood transplant nadir. |
| Secondary | Time to Platelet Engraftment | Up to day 100 post-transplant | Measured by the number of participants with a platelet count \> 20,000/ul without subsequent transfusions for 7 days. Participants who did not reach platelet engraftment by day 100 post-transplant were censored at day 100. |
| Secondary | Number of Participants With Acute Graft Versus Host Disease (aGVHD), by Grade | At day 100 post-transplant | The presence of aGVHD was assessed using the Acute GVHD Grading Scale and represented as overall grade I-IV, with higher grade indicating worse outcomes. Grade I aGVHD is defined as skin stage 1-2 and stage 0 for both GI and liver. Grade II is stage 3 skin, stage 1 GI, or stage 1 liver. Grade III is stage 4 skin or stage 2-4 GI or stage 2-4 liver, without GVHD as a major contributing cause of death. Grade IV is stage 4 skin or stage 2-4 GI or stage 2-4 liver, with GVHD as a major contributing cause of death. |
| Secondary | Number of Participants With Chronic Graft Versus Host Disease (cGVHD), by Severity | 1 year post-transplant | The presence of cGVHD was assessed using the Chronic GVHD Grading Scale, with higher severity indicating worse outcomes. Incidence of moderate or severe cGVHD were considered clinically significant. Mild cGVHD is defined as limited organ involvement with minimal functional impairment, typically affecting 1-2 organs/sites with no major impact on daily activities. Moderate cGVHD is indicated by more extensive organ involvement and/or clinically significant functional impairment, but without major disability. Severe cGVHD is defined as major organ involvement with substantial functional impairment or disability, often requiring intensive systemic therapy. Abnormalities that could indicate cGVHD are reviewed for the following organ systems: skin, nails, hair, mouth, eyes, vagina/vulva (for female patients), liver, lung, GI, fasciitis, serositis, muscle, skeletal. |
| Secondary | Number of Participants With Chronic Graft Versus Host Disease (cGVHD), by Severity | Up to 2 years post-transplant | The presence of cGVHD was assessed using the Chronic GVHD Grading Scale, with higher severity indicating worse outcomes. Incidence of moderate or severe cGVHD were considered clinically significant. Mild cGVHD is defined as limited organ involvement with minimal functional impairment, typically affecting 1-2 organs/sites with no major impact on daily activities. Moderate cGVHD is indicated by more extensive organ involvement and/or clinically significant functional impairment, but without major disability. Severe cGVHD is defined as major organ involvement with substantial functional impairment or disability, often requiring intensive systemic therapy. Abnormalities that could indicate cGVHD are reviewed for the following organ systems: skin, nails, hair, mouth, eyes, vagina/vulva (for female patients), liver, lung, GI, fasciitis, serositis, muscle, skeletal. |
| Secondary | Number of Participants Who Experienced Non-relapse Mortality | At day 100 post-transplant | Non-relapse mortality (NRM) is defined as death without a prior relapse. |
| Secondary | Number of Participants Who Experienced Non-relapse Mortality | At day 180 post-transplant | Non-relapse mortality (NRM) is defined as death without a prior relapse. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| P50HL110787 | Notch-Mediated Expansion of Cord Blood Progenitors for Stem Cell Transplant | DELANEY, COLLEEN | FRED HUTCHINSON CANCER RESEARCH CENTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2012 to 2017 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03399773
GET https://conductscience.org/api/trials/v1/NCT03399773/registered