Trial · NCT03680092

Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation

NCT03680092, Phase 2, Completed, Dimitrios Tzachanis, MD PhD; results first posted 2024-10-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation. Trials, record NCT03680092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03680092

On this page

Trial

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

Title: Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation
NCT number: NCT03680092
Status: Completed
Phases: Phase 2
Enrollment: 43 participants, actual
Lead sponsor: Dimitrios Tzachanis, MD PhD
Conditions: GVHD, Hematologic Neoplasms
Interventions: Cyclophosphamide, abatacept, Methotrexate, Tacrolimus
First posted: 2018-09-21
Last updated: 2025-10-02
Results first posted: 2024-10-02

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Occurrence of Moderate and Severe Chronic GVHD at One Year Post Transplant	through study completion, an average of 1 year	The occurrence of moderate and severe chronic GVHD at one year post Chronic GVHD will be diagnosed and staged according to the previously published and widely accepted National Institutes of Health consensus criteria
Secondary	GVHD- and Relapse- Free Survival by One Year Post Transplant	through study completion, an average of 1 year	GVHD- and relapse- free survival will be defined as the absence of acute GVHD Grade III or IV or moderate or severe chronic GVHD or relapse or non-relapse mortality by one year post transplant. Acute GVHD will be diagnosed and graded according to Glucksberg criteria

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Occurrence of Moderate and Severe Chronic GVHD at One Year Post Transplant	through study completion, an average of 1 year		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	GVHD- and Relapse- Free Survival by One Year Post Transplant	through study completion, an average of 1 year		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Occurrence of Moderate and Severe Chronic GVHD at One Year Post Transplant	Cyclophosphamide and Abatacept	0	Participants
Occurrence of Moderate and Severe Chronic GVHD at One Year Post Transplant	Methotrexate and Tacrolimus	8	Participants
GVHD- and Relapse- Free Survival by One Year Post Transplant	Cyclophosphamide and Abatacept	15	Participants
GVHD- and Relapse- Free Survival by One Year Post Transplant	Methotrexate and Tacrolimus	4	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cyclophosphamide and Abatacept	28
Overall Study	STARTED	Methotrexate and Tacrolimus	15
Overall Study	COMPLETED	Cyclophosphamide and Abatacept	25
Overall Study	COMPLETED	Methotrexate and Tacrolimus	15
Overall Study	NOT COMPLETED	Cyclophosphamide and Abatacept	3
Overall Study	NOT COMPLETED	Methotrexate and Tacrolimus	0

Source ClinicalTrials.gov

Adverse events78

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	CMV Viremia	Infections and infestations	Cyclophosphamide and Abatacept	5	25	5
other	CMV Viremia	Infections and infestations	Methotrexate and Tacrolimus	4	15	6
other	oral mucositis	Gastrointestinal disorders	Cyclophosphamide and Abatacept	3	25	8
other	oral mucositis	Gastrointestinal disorders	Methotrexate and Tacrolimus	9	15	13
other	dry eyes	Eye disorders	Cyclophosphamide and Abatacept	2	25	2
other	dry eyes	Eye disorders	Methotrexate and Tacrolimus	0	15	0
other	Acute kidney injury	Renal and urinary disorders	Cyclophosphamide and Abatacept	0	25	0
other	Acute kidney injury	Renal and urinary disorders	Methotrexate and Tacrolimus	6	15	9
other	BK viremia	Infections and infestations	Cyclophosphamide and Abatacept	0	25	0
other	BK viremia	Infections and infestations	Methotrexate and Tacrolimus	2	15	2

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cyclophosphamide and Abatacept	2	25
Total, all-cause mortality	Methotrexate and Tacrolimus	3	15
Total, other adverse events	Cyclophosphamide and Abatacept	5	25
Total, other adverse events	Methotrexate and Tacrolimus	10	15
Total, serious adverse events	Cyclophosphamide and Abatacept	9	25
Total, serious adverse events	Methotrexate and Tacrolimus	13	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40554429	DERIVED

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 comparisons4

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

Comparison	Source
Cyclophosphamide and Abatacept vs Methotrexate and Tacrolimus: Occurrence of Moderate and Severe Chronic GVHD at One Year Post Transplant	Trial comparisons
Cyclophosphamide and Abatacept vs Methotrexate and Tacrolimus: GVHD- and Relapse- Free Survival by One Year Post Transplant	Trial comparisons
Cyclophosphamide and Abatacept vs Methotrexate and Tacrolimus: deaths from any cause	Trial comparisons
Cyclophosphamide and Abatacept vs Methotrexate and Tacrolimus: 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/NCT03680092

GET https://conductscience.org/api/trials/v1/NCT03680092/events?page=2

API reference For AI assistants