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Crohn's Allogeneic Transplant Study
Phase 2 trial testing Allogeneic Bone Marrow Transplantation in Crohn Disease in 2 participants. Terminated before completion.
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 17 July 2012 |
| Primary completion | 3 February 2019 |
| Estimated completion | 30 October 2019 |
| Sites | 1 location across United States |
Fred Hutchinson Cancer Center — full company profile →
Adults 18 to 60, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Defined as alive and free of active CD. Described graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 1 |
The incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each patient.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 1 |
Evaluated using a standardized tool for evaluating CD (CDAI).
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 0 |
Described graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 1 |
The grading of acute and chronic GVHD will follow previously published guidelines but will also include capture of symptoms and characterization of alternative causes. The highest level of organ abnormalities, the etiologies contributing to the abnormalities and biopsy results pertaining to GVHD will be identified. Since both GVHD and CD involve the gastrointestinal tract, all diagnostic biopsies of these organs will be reviewed by pathologists experienced in the diagnosis of GVHD and IBD, respectively.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 1 |
Includes the administration of any therapy (drugs, biologics, or any other treatments) clearly given as immunomodulatory therapy for underlying CD.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 0 |
Engraftment is defined as achieving \> 5% donor peripheral blood CD3 T cell chimerism by day 84 after HCT. Primary graft failure is defined as a donor peripheral blood CD3 T cell chimerism peak of \< 5% by Day 84 post-HCT. Secondary graft failure is defined as documented engraftment followed by loss of the graft with donor peripheral blood CD3 T cell chimerism \< 5% as demonstrated by a chimerism assay.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 0 |
Characterized by the event rates as functions of all patients enrolled and at risk of the event, with exact confidence intervals.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 0 |
Characterized by the rates of reportable events as functions of all patients enrolled and at risk of the event, with exact confidence intervals. With the exception of adverse events (AEs) that are universal and expected following conditioning therapy, all reportable AEs will be tabulated for each patient from the time that the subject starts mobilization of hematopoietic cells until day +365 after transplant.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 1 |
A stopping rule will be imposed for TRM occurring within one year of transplant. The study will be stopped if at any point there is moderately strong evidence that the rate of TRM exceeds 10%. Moderately strong evidence will be taken to mean that the lower bound of a one-sided 80% confidence interval for the true rate of TRM is above 10%.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Allogeneic BMT) | 1 |
Time frame: Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Allogeneic BMT) |
|---|---|---|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Treatment (Allogeneic BMT) |
|---|---|---|
| thromboembolotic event | Vascular disorders | — |
| CMV Reactivation | Infections and infestations | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Femoral neck stress fracture | Injury, poisoning and procedural complications | — |
| metapneumovirus pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Small intestinal obstruction | Gastrointestinal disorders | — |
| Hypertension | Vascular disorders | — |
| Respiratoroy failure | Respiratory, thoracic and mediastinal disorders | — |
| acute kidney injury | Renal and urinary disorders | — |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | — |
| GI bleed/dirrhea | Gastrointestinal disorders | — |
Most-reported serious reactions: Respiratory Failure.
Data from ClinicalTrials.gov NCT01570348 adverse events section.
This phase II trial studies how well giving a donor bone marrow transplant (BMT) works in treating patients with refractory Crohn's Disease. We will select patients with severe Crohn's Disease and active inflammation despite the best medical and surgical treatments. These patients must be healthy enough to undergo a transplantation procedure. They cannot have an active infection, and their heart, lungs, kidneys, and liver cannot be failing. The transplant procedure starts with chemotherapy and a small dose of radiation, to weaken a patient's immune system so that it will accept bone marrow cells from another person. After that other person's bone marrow cells are given to the patient, immune suppressive medicines are given to prevent the new cells from being rejected and to stop those cells from damaging the patient. After the new donor cells start to work, blood counts will rise and the new immune system will start to grow. During this time, there is a risk of infection. Antibiotics and anti-viral drugs will be given to prevent infection. When the new donor cells are well-established, immune suppressive medicines are discontinued. We will examine parts of the intestine that were inflamed before the start of the transplant procedure, to be sure the Crohn's Disease has disappeared after the transplant. Patients will be formally evaluated for Crohn's activity at around 100 days after transplant, and yearly after that for 5 years.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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