Trial · NCT00305682

Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant

NCT00305682, Phase 2, Completed, Masonic Cancer Center, University of Minnesota; results first posted 2020-11-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant. Trials, record NCT00305682. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00305682

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Trial

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

Title: Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant
NCT number: NCT00305682
Status: Completed
Phases: Phase 2
Enrollment: 295 participants, actual
Lead sponsor: Masonic Cancer Center, University of Minnesota
Conditions: Myeloproliferative Disorders, Leukemia, Lymphoma, Myelodysplastic Syndromes
Interventions: anti-thymocyte globulin, cyclophosphamide, Fludarabine, mycophenolate mofetil, umbilical cord blood transplantation, total body irradiation, Sirolimus
First posted: 2006-03-22
Last updated: 2020-11-19
Results first posted: 2020-11-02

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Number of Participants Who Were Alive at 1 Year Post Transplant	1 Year	Overall Survival - Number of patients alive at 1 year post transplant
Primary	Number of Participants Who Were Alive at 2 Years Post Transplant	2 Years	Overall Survival - Number of patients alive at 2 years post transplant
Secondary	Number of Participants Who Were Dead at 6 Months After Study Completion	Month 6	Incidence of Non-relapse mortality - Number of Patients Dead at 6 Months after study completion
Secondary	Percentage of Donor Chimerism at 21 Days	21 days	Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Secondary	Percentage of Donor Chimerism at 100 Days	100 days	Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Secondary	Percentage of Donor Chimerism at 180 Days	180 Days	Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Secondary	Percentage of Donor Chimerism at 365 Days	365 days	Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis.
Secondary	Number of Participants With Neutrophil Engraftment	Day 42	Time to 1st 3 consecutive days with absolute neutrophil count (ANC) \> 5 x 10\^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence).
Secondary	Number of Participants With Platelet Engraftment	Day 180	Time to platelets \> 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment \>50,000 by day 100.
Secondary	Number of Participants With Acute Graft-versus-host Disease (GVHD)	Day 100	Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Were Alive at 1 Year Post Transplant	1 Year		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Who Were Alive at 2 Years Post Transplant	2 Years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Were Dead at 6 Months After Study Completion	Month 6		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Donor Chimerism at 21 Days	21 days	A total of 43 participants were not evaluable	percentage of donor cells	MEAN
SECONDARY	Percentage of Donor Chimerism at 100 Days	100 days	A total of 85 participants were not evaluable.	percentage of donor cells	MEAN
SECONDARY	Percentage of Donor Chimerism at 180 Days	180 Days	A total of 134 participants were not evaluable	percentage of donor cells	MEAN
SECONDARY	Percentage of Donor Chimerism at 365 Days	365 days	A total of 160 participants were not evaluable	percentage of donor cells	MEAN
SECONDARY	Number of Participants With Neutrophil Engraftment	Day 42	7 participants were not evaluable	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Platelet Engraftment	Day 180	13 participants were not evaluable	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Acute Graft-versus-host Disease (GVHD)	Day 100		Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group89

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

Outcome	Group	Value	Units
Number of Participants Who Were Alive at 1 Year Post Transplant	Arm 1-Previous Autologous Transplant	59	Participants
Number of Participants Who Were Alive at 1 Year Post Transplant	Arm 2 - No Prior Autologous Transplant	40	Participants
Number of Participants Who Were Alive at 1 Year Post Transplant	Arm 3 - Refractory Leukemia/Lymphoma	1	Participants
Number of Participants Who Were Alive at 1 Year Post Transplant	Arm 4: MT2006-01 Coenrolling Patients	26	Participants
Number of Participants Who Were Alive at 1 Year Post Transplant	Arm 5 - Previous Autologous Transplant	26	Participants
Number of Participants Who Were Alive at 1 Year Post Transplant	Arm 6 - No Prior Autologous Transplant	25	Participants
Number of Participants Who Were Alive at 2 Years Post Transplant	Arm 1-Previous Autologous Transplant	50	Participants
Number of Participants Who Were Alive at 2 Years Post Transplant	Arm 2 - No Prior Autologous Transplant	31	Participants
Number of Participants Who Were Alive at 2 Years Post Transplant	Arm 3 - Refractory Leukemia/Lymphoma	1	Participants
Number of Participants Who Were Alive at 2 Years Post Transplant	Arm 4: MT2006-01 Coenrolling Patients	20	Participants

1 to 10 of 89Source ClinicalTrials.gov

See all 89 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1-Previous Autologous Transplant	98
Overall Study	STARTED	Arm 2 - No Prior Autologous Transplant	71
Overall Study	STARTED	Arm 3 - Refractory Leukemia/Lymphoma	7
Overall Study	STARTED	Arm 4: MT2006-01 Coenrolling Patients	34
Overall Study	STARTED	Arm 5 - Previous Autologous Transplant	39
Overall Study	STARTED	Arm 6 - No Prior Autologous Transplant	35
Overall Study	COMPLETED	Arm 1-Previous Autologous Transplant	98
Overall Study	COMPLETED	Arm 2 - No Prior Autologous Transplant	71
Overall Study	COMPLETED	Arm 3 - Refractory Leukemia/Lymphoma	7
Overall Study	COMPLETED	Arm 4: MT2006-01 Coenrolling Patients	34

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events270

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	Acute kidney injury	Renal and urinary disorders	Arm 1-Previous Autologous Transplant	3	98	3
other	Acute kidney injury	Renal and urinary disorders	Arm 2 - No Prior Autologous Transplant	3	71	3
other	Acute kidney injury	Renal and urinary disorders	Arm 3 - Refractory Leukemia/Lymphoma	0	7	0
other	Acute kidney injury	Renal and urinary disorders	Arm 4: MT2006-01 Coenrolling Patients	2	34	3
other	Acute kidney injury	Renal and urinary disorders	Arm 5 - Previous Autologous Transplant	1	39	1
other	Acute kidney injury	Renal and urinary disorders	Arm 6 - No Prior Autologous Transplant	4	35	5
other	Anemia	Blood and lymphatic system disorders	Arm 1-Previous Autologous Transplant	1	98	1
other	Anemia	Blood and lymphatic system disorders	Arm 2 - No Prior Autologous Transplant	0	71	0
other	Anemia	Blood and lymphatic system disorders	Arm 3 - Refractory Leukemia/Lymphoma	0	7	0
other	Anemia	Blood and lymphatic system disorders	Arm 4: MT2006-01 Coenrolling Patients	2	34	2

1 to 10 of 270Source ClinicalTrials.gov

See all 270 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1-Previous Autologous Transplant	48	98
Total, all-cause mortality	Arm 2 - No Prior Autologous Transplant	40	71
Total, all-cause mortality	Arm 3 - Refractory Leukemia/Lymphoma	6	7
Total, all-cause mortality	Arm 4: MT2006-01 Coenrolling Patients	14	34
Total, all-cause mortality	Arm 5 - Previous Autologous Transplant	18	39
Total, all-cause mortality	Arm 6 - No Prior Autologous Transplant	12	35
Total, other adverse events	Arm 1-Previous Autologous Transplant	76	98
Total, other adverse events	Arm 2 - No Prior Autologous Transplant	54	71
Total, other adverse events	Arm 3 - Refractory Leukemia/Lymphoma	5	7
Total, other adverse events	Arm 4: MT2006-01 Coenrolling Patients	20	34

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18997171	DERIVED	PubMed
19167681	RESULT	PubMed
19179301	BACKGROUND	PubMed
21403127	DERIVED	PubMed
22430088	DERIVED	PubMed

Grants0

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.

None in this release.

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.

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/NCT00305682

GET https://conductscience.org/api/trials/v1/NCT00305682/results?page=2

API reference For AI assistants