Trial · NCT01380535

Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)

NCT01380535, Early phase 1, Completed, Mallinckrodt; results first posted 2019-10-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD). Trials, record NCT01380535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01380535

On this page

Trial

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

Title: Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)
NCT number: NCT01380535
Status: Completed
Phases: Early phase 1
Enrollment: 60 participants, actual
Lead sponsor: Mallinckrodt
Conditions: Chronic Graft Versus Host Disease
Interventions: ECP Methoxsalen, Standard of Care
First posted: 2011-06-27
Last updated: 2020-02-19
Other registries' IDs: eudract:2010-022780-35
Results first posted: 2019-10-29
Limitations and caveats: Long term follow-up (LTFU) safety data were provided to health authorities in safety reports; not the 28-week protocol.~LTFU pre-specified outcome measures previously entered in error were removed.

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants With an Overall Response at Week 28	Week 28	Participants with overall response included those with partial response or complete response, according to study staff who did not know which treatment they received (blinded assessment).

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With an Overall Response at Week 28	Week 28	Intention to treat population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With an Overall Response at Week 28	ECP Methoxsalen + SoC		20		Participants
Number of Participants With an Overall Response at Week 28	Standard of Care (SoC)		14		Participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ECP Methoxsalen + SoC	29
Overall Study	STARTED	Standard of Care (SoC)	31
Overall Study	Baseline Population	ECP Methoxsalen + SoC	29
Overall Study	Baseline Population	Standard of Care (SoC)	31
Overall Study	Safety Population	ECP Methoxsalen + SoC	28
Overall Study	Safety Population	Standard of Care (SoC)	28
Overall Study	Intent-to-treat Population	ECP Methoxsalen + SoC	29
Overall Study	Intent-to-treat Population	Standard of Care (SoC)	24
Overall Study	COMPLETED	ECP Methoxsalen + SoC	22
Overall Study	COMPLETED	Standard of Care (SoC)	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events148

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	Anaemia	Blood and lymphatic system disorders	ECP Methoxsalen + SoC	1	28
other	Anaemia	Blood and lymphatic system disorders	Standard of Care (SoC)	2	28
other	Thrombocytopenia	Blood and lymphatic system disorders	ECP Methoxsalen + SoC	2	28
other	Thrombocytopenia	Blood and lymphatic system disorders	Standard of Care (SoC)	4	28
other	Dry Eye	Eye disorders	ECP Methoxsalen + SoC	2	28
other	Dry Eye	Eye disorders	Standard of Care (SoC)	1	28
other	Abdominal Pain	Gastrointestinal disorders	ECP Methoxsalen + SoC	1	28
other	Abdominal Pain	Gastrointestinal disorders	Standard of Care (SoC)	2	28
other	Constipation	Gastrointestinal disorders	ECP Methoxsalen + SoC	1	28
other	Constipation	Gastrointestinal disorders	Standard of Care (SoC)	3	28

1 to 10 of 148Source ClinicalTrials.gov

See all 148 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ECP Methoxsalen + SoC	4	29
Total, all-cause mortality	Standard of Care (SoC)	0	31
Total, other adverse events	ECP Methoxsalen + SoC	26	28
Total, other adverse events	Standard of Care (SoC)	24	28
Total, serious adverse events	ECP Methoxsalen + SoC	8	28
Total, serious adverse events	Standard of Care (SoC)	9	28

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31332045	RESULT

Source 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 comparisons3

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

Comparison	Source
ECP Methoxsalen + SoC vs Standard of Care (SoC): Number of Participants With an Overall Response at Week 28	Trial comparisons
ECP Methoxsalen + SoC vs Standard of Care (SoC): deaths from any cause	Trial comparisons
ECP Methoxsalen + SoC vs Standard of Care (SoC): 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/NCT01380535

GET https://conductscience.org/api/trials/v1/NCT01380535/events?page=2

API reference For AI assistants