Trial · NCT00067002

Randomized Double Cord Blood Transplant Study

NCT00067002, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2019-05-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized Double Cord Blood Transplant Study. Trials, record NCT00067002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00067002

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Trial

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

Title: Randomized Double Cord Blood Transplant Study
NCT number: NCT00067002
Status: Completed
Phases: Phase 2
Enrollment: 110 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Leukemia, Lymphocytic, Acute, Leukemia, Myelocytic, Acute, Leukemia, Myeloid, Chronic, Lymphoma, Non-Hodgkin
Interventions: Expanded allogeneic cord blood (CB), One Unmanipulated and One Expanded Cord Blood Unit, Rituxan, Melphalan, Thiotepa, Fludarabine, Cyclophosphamide, Mesna, Total body irradiation (TBI)
First posted: 2003-08-11
Last updated: 2019-05-01
Results first posted: 2019-05-01

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Time To Neutrophil Engraftment	First 100 days, evaluation and blood tests twice weekly	Engraftment is defined as a sustained ANC \> 0.5 x 10\^9/L for at least 3 consecutive days. Engraftment date is the first of the 3 days with sustained absolute neutrophil count (ANC) \>/= 0.5 x 10\^9/L.
Primary	Number of Participants With Engraftment	First 100 days, evaluation and blood tests twice weekly	Engraftment defined as a sustained absolute neutrophil count (ANC) \> 0.5 x 10\^9/L for at least 3 consecutive days. Engraftment Failure defined as ANC \<500/ul by day +42 and participant has no evidence of donor chimerism on bone marrow examination.
Secondary	Rate of Acute Graft Versus Host Disease (GVHD)	Review over first 100 days	Number of participants who display features of acute GVHD within 100 days of transplant.
Secondary	Rate of Chronic GVHD	Up to one year	Number of participants who present GVHD post-transplant and display features of chronic GVHD. Diagnostic and distinctive features of chronic GVHD are present. There are no features of acute GVHD.
Secondary	Number of Participants Severity of Acute GVHD by Treatment Arm	Following first 100 days, up to one year	The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. The stages of individual organ involvement is assessed using Glucksberg grade (I-IV) where Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time To Neutrophil Engraftment	First 100 days, evaluation and blood tests twice weekly		Days	MEDIAN
PRIMARY	Number of Participants With Engraftment	First 100 days, evaluation and blood tests twice weekly		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Rate of Acute Graft Versus Host Disease (GVHD)	Review over first 100 days	Acute GVHD percentage calculated using engrafted participants only (n=89; expanded 44; un-manipulated 45)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Rate of Chronic GVHD	Up to one year	Chronic GVHD percentage calculated using engrafted patients and alive after 100 days (n=77; expanded 40; unmanipulated 37)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Severity of Acute GVHD by Treatment Arm	Following first 100 days, up to one year	For the Acute GVHD the analysis was performed on patients with GVHD in the first 100 days.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Category	Value	Spread	Units
Time To Neutrophil Engraftment	Un-Manipulated CB Arm		17	Full Range 5 to 45	Days
Time To Neutrophil Engraftment	Expanded CB Arm		15	Full Range 4 to 43	Days
Number of Participants With Engraftment	Un-Manipulated CB Arm		45		Participants
Number of Participants With Engraftment	Expanded CB Arm		44		Participants
Rate of Acute Graft Versus Host Disease (GVHD)	Un-Manipulated CB Arm		29		Participants
Rate of Acute Graft Versus Host Disease (GVHD)	Expanded CB Arm		24		Participants
Rate of Chronic GVHD	Un-Manipulated CB Arm	Overall Chronic GVHD	16		Participants
Rate of Chronic GVHD	Expanded CB Arm	Overall Chronic GVHD	20		Participants
Rate of Chronic GVHD	Un-Manipulated CB Arm	Limited	10		Participants
Rate of Chronic GVHD	Expanded CB Arm	Limited	14		Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Double Cord Blood Transplant Group (Un-Manipulated)	52
Overall Study	STARTED	One Expanded Cord Blood Transplant Group (Expanded)	53
Overall Study	COMPLETED	Double Cord Blood Transplant Group (Un-Manipulated)	45
Overall Study	COMPLETED	One Expanded Cord Blood Transplant Group (Expanded)	44
Overall Study	NOT COMPLETED	Double Cord Blood Transplant Group (Un-Manipulated)	7
Overall Study	NOT COMPLETED	One Expanded Cord Blood Transplant Group (Expanded)	9

Source ClinicalTrials.gov

Adverse events402

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	Abdomen Distension	Gastrointestinal disorders	Un-Manipulated CB Arm	1	52	1
other	Abdomen Distension	Gastrointestinal disorders	Expanded CB Arm	0	53	0
other	Abdomen Pain	Gastrointestinal disorders	Un-Manipulated CB Arm	4	52	4
other	Abdomen Pain	Gastrointestinal disorders	Expanded CB Arm	5	53	5
other	Acne	Skin and subcutaneous tissue disorders	Un-Manipulated CB Arm	0	52	0
other	Acne	Skin and subcutaneous tissue disorders	Expanded CB Arm	1	53	1
other	Alkaline Phosphate Increase	Investigations	Un-Manipulated CB Arm	5	52	5
other	Alkaline Phosphate Increase	Investigations	Expanded CB Arm	2	53	2
other	Allergic Reaction	Immune system disorders	Un-Manipulated CB Arm	2	52	2
other	Allergic Reaction	Immune system disorders	Expanded CB Arm	5	53	5

1 to 10 of 402Source ClinicalTrials.gov

See all 402 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Un-Manipulated CB Arm
Total, all-cause mortality	Expanded CB Arm
Total, other adverse events	Un-Manipulated CB Arm	52	52
Total, other adverse events	Expanded CB Arm	53	53
Total, serious adverse events	Un-Manipulated CB Arm	9	52
Total, serious adverse events	Expanded CB Arm	4	53

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons3

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

Comparison	Source
Un-Manipulated CB Arm vs Expanded CB Arm: Rate of Acute Graft Versus Host Disease (GVHD)	Trial comparisons
Un-Manipulated CB Arm vs Expanded CB Arm: Number of Participants With Engraftment	Trial comparisons
Un-Manipulated CB Arm vs Expanded CB Arm: 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/NCT00067002

GET https://conductscience.org/api/trials/v1/NCT00067002/events?page=2

API reference For AI assistants