Trial · NCT01005576

Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia

NCT01005576, Phase 2, Completed, Washington University School of Medicine; results first posted 2017-10-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia. Trials, record NCT01005576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01005576

On this page

Trial

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

Title: Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia
NCT number: NCT01005576
Status: Completed
Phases: Phase 2
Enrollment: 21 participants, actual
Lead sponsor: Washington University School of Medicine
Conditions: Severe Thalassemia
Interventions: Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan
First posted: 2009-11-02
Last updated: 2017-12-13
Results first posted: 2017-10-20

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame
Primary	Primary Objective: Event-free Survival at 1 Year.	1 year
Secondary	Development of Graft Versus Host Disease (GVHD)	2 years
Secondary	Median Time to ANC Engraftment	100 days
Secondary	Median Time to Platelet Engraftment	100 days
Secondary	Incidence of Disease Recurrence	2 years

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	Primary Objective: Event-free Survival at 1 Year.	1 year		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Development of Graft Versus Host Disease (GVHD)	2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Time to ANC Engraftment	100 days		days	MEDIAN
SECONDARY	Median Time to Platelet Engraftment	100 days	3 participants did not engraft platelets	days	MEDIAN
SECONDARY	Incidence of Disease Recurrence	2 years		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Spread	Units
Primary Objective: Event-free Survival at 1 Year.	Conditioning Regimen		17		Participants
Development of Graft Versus Host Disease (GVHD)	Conditioning Regimen	Participants who developed any GVHD	12		Participants
Development of Graft Versus Host Disease (GVHD)	Conditioning Regimen	Participants who did not develop any GVHD	9		Participants
Median Time to ANC Engraftment	Conditioning Regimen		14	Full Range 10 to 46	days
Median Time to Platelet Engraftment	Conditioning Regimen		27.5	Full Range 18 to 234	days
Incidence of Disease Recurrence	Conditioning Regimen		1		Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Conditioning Regimen	21
Overall Study	COMPLETED	Conditioning Regimen	21
Overall Study	NOT COMPLETED	Conditioning Regimen	0

Source ClinicalTrials.gov

Adverse events13

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
other	CMV reactivation	Infections and infestations	Conditioning Regimen	14	21
other	Veno Occlusive Disease	Hepatobiliary disorders	Conditioning Regimen	1	21
other	Hyperbilirubinemia	Investigations	Conditioning Regimen	1	21
other	Hypercalcemia	Investigations	Conditioning Regimen	1	21
other	Acute Kidney Injury	Renal and urinary disorders	Conditioning Regimen	1	21
other	Infection (other than CMV)	Infections and infestations	Conditioning Regimen	21	21
serious	Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	Conditioning Regimen	4	21
serious	Pain	General disorders	Conditioning Regimen	1	21
serious	Graft rejection	General disorders	Conditioning Regimen	1	21
serious	Edema	General disorders	Conditioning Regimen	1	21

1 to 10 of 13Source ClinicalTrials.gov

See all 13 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Conditioning Regimen	4	21
Total, other adverse events	Conditioning Regimen	21	21
Total, serious adverse events	Conditioning Regimen	10	21

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 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/NCT01005576

GET https://conductscience.org/api/trials/v1/NCT01005576/registered

API reference For AI assistants