Trial · NCT00719888

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

NCT00719888, Phase 2, Completed, Fred Hutchinson Cancer Center; results first posted 2025-03-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease. Trials, record NCT00719888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00719888

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease
NCT number: NCT00719888
Status: Completed
Phases: Phase 2
Enrollment: 135 participants, actual
Lead sponsor: Fred Hutchinson Cancer Center
Conditions: Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Burkitt Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Follicular Lymphoma, Lymphoblastic Lymphoma, Lymphoplasmacytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Myelodysplastic Syndrome, Myelofibrosis, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Prolymphocytic Leukemia, Refractory Anemia, Small Lymphocytic Lymphoma
Interventions: Cyclophosphamide, Cyclosporine, Double-Unit Umbilical Cord Blood Transplantation, Fludarabine, Laboratory Biomarker Analysis, Mycophenolate Mofetil, Total-Body Irradiation, Umbilical Cord Blood Transplantation, Thiotepa
First posted: 2008-07-22
Last updated: 2025-03-07
Results first posted: 2025-03-07
Limitations and caveats: Study initiated in 2005, but Arm B was added to the study design in 2019. Therefore patient accrual in Arm B is lower than Arm A, though rate of accrual was comparable once both arms were available.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	1 year post-transplant	Overall survival defined as patient being alive at 1 year post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.
Secondary	Change in Level of Chimerism at Multiple Time Points	Baseline up to 2 years post-transplant	Peripheral blood chimerism studies (sorted for CD3, CD14, CD33, CD56 cells) were collected for all UCBT recipients for days 28, 56, 80, 365, and 730 post-transplant. The combined median of the percent donor, along with full range, is captured to show change in level of chimerism at multiple time points up to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.
Secondary	Incidence of Transplant-related Mortality (TRM)	At 6 months post-transplant	Defined as death due to complication (other than relapse) within 6 months following UCBT. Monitoring will take place separately for the single and double UCBT cohorts.
Secondary	Neutrophil Engraftment	Up to day 42 post-transplant	Neutrophil engraftment after UCBT is defined as the first day of absolute neutrophil count (ANC) ≥ 5 x 10⁸/L for 3 consecutive measures. Monitoring will take place separately for the single and double UCBT cohorts.
Secondary	Platelet Engraftment	Up to 6 months post-transplant	Platelet (PLT) engraftment after UCBT is defined as the first day of platelet count \> 20,000/μl without subsequent transfusions for 7 days. Monitoring will take place separately for the single and double UCBT cohorts.
Secondary	Event of Grade II-IV and III-IV Acute Graft-versus-host Disease (aGVHD)	Up to day 100 post-transplant	Each event of aGVHD will be assigned an overall aGVHD score based on extent of skin rash, volume of diarrhea, and maximum bilirubin level, per protocol Appendix I, "GVHD Staging and Grading." Scores reported range from most mild at 2, to worse at 4. Monitoring will take place separately for the single and double UCBT cohorts.
Secondary	Event of Chronic Graft-verses-host-disease (cGVHD)	Up to 2 years post-transplant	Each event of cGVHD level will be assessed overall as either 'Limited' (mild and with single organ involvement) or 'Extensive' (involvement of two or more organs with symptoms) based on extent of skin rash, volume of diarrhea, and maximum bilirubin level, per protocol Appendix I, "GVHD Staging and Grading." Monitoring will take place separately for the single and double UCBT cohorts.
Secondary	Event of Clinically Significant Infections	Up to 2 years post-transplant	Each event of infection will be assessed to determine whether or not it is clinically significant. An infection is defined as clinically significant when it is scored as ≥ grade 3 (where worse outcomes are associated with higher grading) in accordance with the CTCAE version 3.0/protocol Appendix VI, and constitutes a Serious Adverse Event (SAE). Monitoring will take place separately for the single and double UCBT cohorts.
Secondary	Incidence of Relapse	At 1 and 2 years post-transplant	Relapse is defined as post-transplant disease recurrence in participants who had initially recovered or improved, with incidence measured from Day 0 to 1 year post-transplant, and from 1 year post-transplant to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.
Secondary	Progression-free Survival (PFS)	Up to 2 years post-transplant	PFS is defined as the time (in days) from UCBT until the disease progresses or the patient dies from any cause, with incidence measured up to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts. Measure will be reported as the median amount of days from full minimum and maximum range.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	1 year post-transplant	Analysis population is all patients who underwent UCB transplant on study, whether completed treatment on study or relapsed at later timepoint.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Level of Chimerism at Multiple Time Points	Baseline up to 2 years post-transplant	Participants who received UCBT on study with chimerism data available within window as specified in protocol.	percentage chimerism (%)	MEDIAN
SECONDARY	Incidence of Transplant-related Mortality (TRM)	At 6 months post-transplant	Analysis population is all patients who underwent UCB transplant on study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Neutrophil Engraftment	Up to day 42 post-transplant	Analysis population is all patients who underwent UCB transplant and experienced ANC engraftment by day 42 post-transplant on study. 4 patients did engraft ANC after day 42 post-transplant, but are not included in this analysis due to protocol definition of engraftment period.	Days post-transplant	MEDIAN
SECONDARY	Platelet Engraftment	Up to 6 months post-transplant	Analysis population is all patients who underwent UCB transplant and experienced PLT engraftment by 6 months post-transplant on study.	Days post-transplant	MEDIAN
SECONDARY	Event of Grade II-IV and III-IV Acute Graft-versus-host Disease (aGVHD)	Up to day 100 post-transplant	Participants who received UCBT on study.	events	NUMBER
SECONDARY	Event of Chronic Graft-verses-host-disease (cGVHD)	Up to 2 years post-transplant	Participants who received UCBT on study.	events	NUMBER
SECONDARY	Event of Clinically Significant Infections	Up to 2 years post-transplant	Participants who received UCBT on study.	events	NUMBER
SECONDARY	Incidence of Relapse	At 1 and 2 years post-transplant	Analysis population is all patients who underwent UCB transplant on study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression-free Survival (PFS)	Up to 2 years post-transplant	Analysis population is all patients who underwent UCB transplant on study.	Days post-transplant	MEDIAN

Source ClinicalTrials.gov

Results by group68

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant		28		Participants
Overall Survival	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant		15		Participants
Overall Survival	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant		53		Participants
Overall Survival	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant		7		Participants
Change in Level of Chimerism at Multiple Time Points	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	Combined median of CD3 at days (24, 56, 80, 180, 365, 730)	100	Full Range 44 to 100	percentage chimerism (%)
Change in Level of Chimerism at Multiple Time Points	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	Combined median of CD3 at days (24, 56, 80, 180, 365, 730)	100	Full Range 69 to 100	percentage chimerism (%)
Change in Level of Chimerism at Multiple Time Points	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	Combined median of CD3 at days (24, 56, 80, 180, 365, 730)	100	Full Range 67 to 100	percentage chimerism (%)
Change in Level of Chimerism at Multiple Time Points	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	Combined median of CD3 at days (24, 56, 80, 180, 365, 730)	100	Full Range 88 to 100	percentage chimerism (%)
Change in Level of Chimerism at Multiple Time Points	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	Combined median of CD14 at days (24, 56, 80, 180, 365, 730)	100	Full Range 0 to 100	percentage chimerism (%)
Change in Level of Chimerism at Multiple Time Points	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	Combined median of CD14 at days (24, 56, 80, 180, 365, 730)	100	Full Range 100 to 100	percentage chimerism (%)

1 to 10 of 68Source ClinicalTrials.gov

See all 68 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	108
Overall Study	STARTED	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	27
Overall Study	Started: Single-cord Transplant	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	34
Overall Study	Started: Single-cord Transplant	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	17
Overall Study	Started: Double-cord Transplant	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	74
Overall Study	Started: Double-cord Transplant	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	10
Overall Study	Completed: Single-cord Transplant	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	26
Overall Study	Completed: Single-cord Transplant	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	10
Overall Study	Completed: Double-cord Transplant	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	48
Overall Study	Completed: Double-cord Transplant	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	5

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events214

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Allergic reaction/hypersensitivity	Immune system disorders	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	2	108	2
other	Allergic reaction/hypersensitivity	Immune system disorders	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	1	27	1
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	33	108	50
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	14	27	14
other	CD4 count	Blood and lymphatic system disorders	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	2	108	2
other	CD4 count	Blood and lymphatic system disorders	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	0	27	0
other	Leukocytes	Blood and lymphatic system disorders	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	1	108	1
other	Leukocytes	Blood and lymphatic system disorders	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	0	27	0
other	Hemolysis	Blood and lymphatic system disorders	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	5	108	5
other	Hemolysis	Blood and lymphatic system disorders	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	0	27	0

1 to 10 of 214Source ClinicalTrials.gov

See all 214 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	24	108
Total, all-cause mortality	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	9	27
Total, other adverse events	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	73	108
Total, other adverse events	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	25	27
Total, serious adverse events	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide	47	108
Total, serious adverse events	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa	7	27

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42907159	DERIVED

Source PubMed

Grants1

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
P30CA015704	Cancer Center Support Grant	LYNCH, THOMAS JAMES	FRED HUTCHINSON CANCER CENTER	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide vs Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa: deaths from any cause	Trial comparisons
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide vs Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00719888

GET https://conductscience.org/api/trials/v1/NCT00719888/results?page=2

API reference For AI assistants