Trial · NCT02133924
Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease
NCT02133924, Phase 2, Completed, John Levine; results first posted 2022-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease. Trials, record NCT02133924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02133924
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease
- NCT number
- NCT02133924
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- John Levine
- Conditions
- Acute Graft Versus Host Disease
- Interventions
- natalizumab, steroids
- First posted
- 2014-05-08
- Last updated
- 2022-10-21
- Results first posted
- 2022-10-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Response (CR) | Day 28 | The primary endpoint for this clinical study is the proportion of complete response, CR (that is, the percent of patients with skin, liver, and GI GVHD - all stage 0) at day 28 of study treatment. Stage 0 = no rash, total bilirubin \<2 mg/dl, diarrhea \<500 ml/d |
| Secondary | Number of Participants With Overall Survival (OS) | 1 year | Number of participants with overall survival at 1 year |
| Secondary | Number of Participants With Non-Relapse Mortality (NRM) | 6 months and 1 year | Number of participants with Non-Relapse Mortality (NRM) at 6 months and 1 year |
| Secondary | Number of Participants With SR GVHD | 1 year | Number of participants with steroid-refractory (SR) GVHD to express cumulative incidence of treatment-refractory GVHD (defined as absence of CR or PR on day 28 of treatment or who receive additional immunosuppression prior to day 28) |
| Secondary | Time to Discontinuation of Steroid Therapy | up to 365 days | Time in days to discontinuation of steroid therapy. |
| Secondary | Number of Participants Who Received Additional GVHD Therapies | 1 year | Number of participants who received additional GVHD therapies (defined as the initiation of a new acute GVHD therapy, regardless of duration) |
| Secondary | Number of Serious Infections | 6 months | Number of serious infections (defined as score 3 by the Blood and Marrow Transplant Clinical Trials Network) |
| Secondary | Number of Participants With Overall Response Rate (CR + PR) | Day 28 | Overall response rate (CR + PR) at day 28. Partial Response (PR) is defined as improvement in one or more organs involved with GVHD symptoms without progression in others. For a response to be scored as PR on day 28, the patient must be in PR on day 28 and have had no intervening non-study therapy for acute GVHD. |
Source ClinicalTrials.gov
Outcomes8
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 Complete Response (CR) | Day 28 | one participant data inevaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Survival (OS) | 1 year | one participant data inevaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Non-Relapse Mortality (NRM) | 6 months and 1 year | one participant data inevaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With SR GVHD | 1 year | one participant data inevaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Discontinuation of Steroid Therapy | up to 365 days | one participant data inevaluable | days | MEDIAN |
| SECONDARY | Number of Participants Who Received Additional GVHD Therapies | 1 year | one participant data inevaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Serious Infections | 6 months | one participant data inevaluable | events | NUMBER |
| SECONDARY | Number of Participants With Overall Response Rate (CR + PR) | Day 28 | one participant data inevaluable | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
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 Complete Response (CR) | Participants With High Risk Acute Graft-Versus-Host Disease | 34 | Participants | ||
| Number of Participants With Overall Survival (OS) | Participants With High Risk Acute Graft-Versus-Host Disease | 37 | Participants | ||
| Number of Participants With Non-Relapse Mortality (NRM) | Participants With High Risk Acute Graft-Versus-Host Disease | 6 months | 25 | Participants | |
| Number of Participants With Non-Relapse Mortality (NRM) | Participants With High Risk Acute Graft-Versus-Host Disease | 1 year | 28 | Participants | |
| Number of Participants With SR GVHD | Participants With High Risk Acute Graft-Versus-Host Disease | 30 | Participants | ||
| Time to Discontinuation of Steroid Therapy | Participants With High Risk Acute Graft-Versus-Host Disease | 108 | Full Range 30 to 365 | days | |
| Number of Participants Who Received Additional GVHD Therapies | Participants With High Risk Acute Graft-Versus-Host Disease | 33 | Participants | ||
| Number of Serious Infections | Participants With High Risk Acute Graft-Versus-Host Disease | 52 | events | ||
| Number of Participants With Overall Response Rate (CR + PR) | Participants With High Risk Acute Graft-Versus-Host Disease | 45 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With High Risk Acute Graft-Versus-Host Disease | 76 | |
| Overall Study | COMPLETED | Participants With High Risk Acute Graft-Versus-Host Disease | 34 | |
| Overall Study | NOT COMPLETED | Participants With High Risk Acute Graft-Versus-Host Disease | 42 |
Source ClinicalTrials.gov
Adverse events76
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 | Anemia | Blood and lymphatic system disorders | Participants With High Risk Acute Graft-Versus-Host Disease | 11 | 75 | |
| other | Anxiety | Psychiatric disorders | Participants With High Risk Acute Graft-Versus-Host Disease | 1 | 75 | |
| other | Hypertension | Vascular disorders | Participants With High Risk Acute Graft-Versus-Host Disease | 3 | 75 | |
| other | Delirium | Psychiatric disorders | Participants With High Risk Acute Graft-Versus-Host Disease | 1 | 75 | |
| other | Edema | General disorders | Participants With High Risk Acute Graft-Versus-Host Disease | 6 | 75 | |
| other | GI Hemorrhage | Gastrointestinal disorders | Participants With High Risk Acute Graft-Versus-Host Disease | 3 | 75 | |
| other | GVHD | Immune system disorders | Participants With High Risk Acute Graft-Versus-Host Disease | 2 | 75 | |
| other | Hematuria | Renal and urinary disorders | Participants With High Risk Acute Graft-Versus-Host Disease | 1 | 75 | |
| other | Hemolytic Anemia | Blood and lymphatic system disorders | Participants With High Risk Acute Graft-Versus-Host Disease | 1 | 75 | |
| other | Blood Bilirubin Increased | Investigations | Participants With High Risk Acute Graft-Versus-Host Disease | 4 | 75 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With High Risk Acute Graft-Versus-Host Disease | 38 | 75 |
| Total, other adverse events | Participants With High Risk Acute Graft-Versus-Host Disease | 32 | 75 |
| Total, serious adverse events | Participants With High Risk Acute Graft-Versus-Host Disease | 51 | 75 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37235690 | 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 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.
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/NCT02133924
GET https://conductscience.org/api/trials/v1/NCT02133924/events?page=2