Trial · NCT02993783
A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
NCT02993783, Phase 2, Terminated, Millennium Pharmaceuticals, Inc.; results first posted 2019-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT). Trials, record NCT02993783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02993783
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
- NCT number
- NCT02993783
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation
- Interventions
- Vedolizumab
- First posted
- 2016-12-15
- Last updated
- 2019-05-24
- Other registries' IDs
- eudract:2016-002985-30
- Results first posted
- 2019-05-24
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Overall Response (Partial Response [PR]+Very Good Partial Response [VGPR]+Complete Response [CR]) at Day 28 | Day 28 | CR is defined as the resolution of all signs and symptoms of acute graft-versus-host-disease (GvHD). VGPR is defined as resolution of the signs and symptoms of the GvHD: 1) Skin: no rash, or residual erythematous rash involving \<25% of the body surface, without bullae (excluding residual faint erythema and hyperpigmentation). 2) Liver: total serum bilirubin concentration \<2 mg/dL or \<25% of baseline at enrollment. 3) Gut: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of 1 GvHD stage in 1 or more organs without progression in any organ. |
| Primary | Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28 | From first dose up to Day 28 | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. |
| Secondary | Percentage of Participants Who Died in the Absence of Primary Malignancy Relapse After Allo-HSCT at Month 6 | Month 6 | |
| Secondary | Percentage of Participants With Acute GvHD Complete Response (CR) at Day 28 | Day 28 | CR is defined as the resolution of all signs and symptoms of acute GvHD. |
| Secondary | Percentage of Participants With Intestinal Overall Response at Day 28 | Day 28 | Symptoms of acute intestinal GvHD were measured using the BMT CTN-modified International Bone Marrow Transplant Registry Database (IBMTR) index. Intestinal overall response is either CR, VGPR or PR for intestine only. CR is defined as the resolution of all signs and symptoms of GvHD. VGPR is defined as resolution of the majority of signs and symptoms of intestinal GvHD: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of intestinal GvHD by at least 1 stage. |
| Secondary | Kaplan-Meier Estimate of Percentage of Participants Achieving Survival at Months 6 and 12 | Months 6 and 12 | The Kaplan-Meier estimate reports the percentage of participants surviving at Months 6 and 12. |
| Secondary | Percentage of Participants Alive Without GvHD or Primary Malignancy Relapse at Months 6 and 12 | Months 6 and 12 | |
| Secondary | Total Dose of Steroids Administered | From first dose of study drug up to Months 6 and 12 | Total Steroids administered in mg/kg/day of methylprednisolone or equivalent |
| Secondary | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | From first dose of study drug to 18 weeks after last dose (Up to Week 32) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. |
| Secondary | Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Week 32 | From first dose of study drug to 18 weeks after last dose (Up to Week 32) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Overall Response (Partial Response [PR]+Very Good Partial Response [VGPR]+Complete Response [CR]) at Day 28 | Day 28 | Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28 | From first dose up to Day 28 | SAS included all participants who received any amount of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Died in the Absence of Primary Malignancy Relapse After Allo-HSCT at Month 6 | Month 6 | Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Acute GvHD Complete Response (CR) at Day 28 | Day 28 | Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Intestinal Overall Response at Day 28 | Day 28 | Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Percentage of Participants Achieving Survival at Months 6 and 12 | Months 6 and 12 | Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive Without GvHD or Primary Malignancy Relapse at Months 6 and 12 | Months 6 and 12 | Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Total Dose of Steroids Administered | From first dose of study drug up to Months 6 and 12 | Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment. | mg/kg/day | MEAN |
| SECONDARY | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | From first dose of study drug to 18 weeks after last dose (Up to Week 32) | SAS included all participants who received any amount of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Week 32 | From first dose of study drug to 18 weeks after last dose (Up to Week 32) | SAS included all participants who received any amount of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group118
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Overall Response (Partial Response [PR]+Very Good Partial Response [VGPR]+Complete Response [CR]) at Day 28 | Vedolizumab 300 mg | 50.0 | 95% Confidence Interval 15.7 to 84.3 | percentage of participants | |
| Percentage of Participants With Overall Response (Partial Response [PR]+Very Good Partial Response [VGPR]+Complete Response [CR]) at Day 28 | Vedolizumab 600 mg | 22.2 | 95% Confidence Interval 2.8 to 60.0 | percentage of participants | |
| Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28 | Vedolizumab 300 mg | 3 | Participants | ||
| Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28 | Vedolizumab 600 mg | 4 | Participants | ||
| Percentage of Participants Who Died in the Absence of Primary Malignancy Relapse After Allo-HSCT at Month 6 | Vedolizumab 300 mg | 50.0 | 95% Confidence Interval 15.7 to 84.3 | percentage of participants | |
| Percentage of Participants Who Died in the Absence of Primary Malignancy Relapse After Allo-HSCT at Month 6 | Vedolizumab 600 mg | 88.9 | 95% Confidence Interval 68.4 to 100.0 | percentage of participants | |
| Percentage of Participants With Acute GvHD Complete Response (CR) at Day 28 | Vedolizumab 300 mg | 12.5 | 95% Confidence Interval 0.3 to 52.7 | percentage of participants | |
| Percentage of Participants With Acute GvHD Complete Response (CR) at Day 28 | Vedolizumab 600 mg | 0 | 95% Confidence Interval 0 to 0 | percentage of participants | |
| Percentage of Participants With Intestinal Overall Response at Day 28 | Vedolizumab 300 mg | 62.5 | 95% Confidence Interval 24.5 to 91.5 | percentage of participants | |
| Percentage of Participants With Intestinal Overall Response at Day 28 | Vedolizumab 600 mg | 33.3 | 95% Confidence Interval 7.5 to 70.1 | percentage of participants |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vedolizumab 300 mg | 8 | |
| Overall Study | STARTED | Vedolizumab 600 mg | 9 | |
| Overall Study | COMPLETED | Vedolizumab 300 mg | 2 | |
| Overall Study | COMPLETED | Vedolizumab 600 mg | 0 | |
| Overall Study | NOT COMPLETED | Vedolizumab 300 mg | 6 | |
| Overall Study | NOT COMPLETED | Vedolizumab 600 mg | 9 |
Source ClinicalTrials.gov
Adverse events406
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 | Anaemia | Blood and lymphatic system disorders | Vedolizumab 300 mg | 4 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Vedolizumab 600 mg | 3 | 9 | |
| other | Neutropenia | Blood and lymphatic system disorders | Vedolizumab 300 mg | 1 | 8 | |
| other | Neutropenia | Blood and lymphatic system disorders | Vedolizumab 600 mg | 3 | 9 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Vedolizumab 300 mg | 2 | 8 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Vedolizumab 600 mg | 1 | 9 | |
| other | Aplasia pure red cell | Blood and lymphatic system disorders | Vedolizumab 300 mg | 1 | 8 | |
| other | Aplasia pure red cell | Blood and lymphatic system disorders | Vedolizumab 600 mg | 0 | 9 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Vedolizumab 300 mg | 0 | 8 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Vedolizumab 600 mg | 1 | 9 |
1 to 10 of 406Source ClinicalTrials.gov
See all 406 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vedolizumab 300 mg | 4 | 8 |
| Total, all-cause mortality | Vedolizumab 600 mg | 9 | 9 |
| Total, other adverse events | Vedolizumab 300 mg | 8 | 8 |
| Total, other adverse events | Vedolizumab 600 mg | 9 | 9 |
| Total, serious adverse events | Vedolizumab 300 mg | 6 | 8 |
| Total, serious adverse events | Vedolizumab 600 mg | 9 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34108672 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vedolizumab 300 mg vs Vedolizumab 600 mg: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| Vedolizumab 300 mg vs Vedolizumab 600 mg: Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Week 32 | Trial comparisons |
| Vedolizumab 300 mg vs Vedolizumab 600 mg: Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28 | Trial comparisons |
| Vedolizumab 300 mg vs Vedolizumab 600 mg: deaths from any cause | Trial comparisons |
| Vedolizumab 300 mg vs Vedolizumab 600 mg: 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.
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.
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