Percentage of GI Toxicity From the Preparatory Regimen and the GVHD Prophylaxis in Stem Cell Transplantation (SCT) Patients Who Are Treated With Pasireotide
| Group | Value (Participants) |
|---|---|
| Pasireotide + Preparatory Regimen | 21 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to evaluate if the drug, Pasireotide, is safe and effective in reducing the gastrointestinal side effects of the drugs received to prepare for allogeneic stem cell transplant. The study will also evaluate if Pasireotide is effective in reducing acute and chronic Graft-versus-Host-Disease (GvHD) after transplant.
Experimental
Pasireotide + Preparatory Regimen
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
Outcomes the sponsor listed as primary.
Percentage of GI Toxicity From the Preparatory Regimen and the GVHD Prophylaxis in Stem Cell Transplantation (SCT) Patients Who Are Treated With Pasireotide
Time frame · 30 Days
Number of participants who experience grades III-IV GI toxicity
Percentage of Acute GVHD
Time frame · 100 days
Number of participants who experience acute GVHD
Maximum Severity of Acute GVHD Compared to Historical Controls
Time frame · 100 days
Assess maximum severity of acute GVHD scored as stage 1 (least severe) through stage 4 (most severe) using BMT CTN, 2013 standards
Incidence of Chronic GVHD Compared to Historical Controls
Time frame · 1 year
Measure the number of participants who experience chronic GVHD
Maximum Severity of Chronic GVHD Compared to Historical Controls
Time frame · 1 year
Assess maximum severity of chronic GVHD scored as none, mild, moderate or severe using 2014 NIH Consensus Criteria
Overall Survival Compared to Historical Controls
Time frame · 1 year
Rate of overall survival of participants at one year post transplant
Disease Free Survival Compared to Historical Controls
Time frame · 1 year
Rate of disease free survival of participants at one year post transplant
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Pasireotide + Preparatory Regimen | 21 |
| Group | Value (Participants) |
|---|---|
| Pasireotide + Preparatory Regimen | 15 |
| Group | Value (units on a scale) |
|---|---|
| Pasireotide + Preparatory Regimen | 2 |
| Group | Value (Participants) |
|---|---|
| Pasireotide + Preparatory Regimen | 16 |
| Historical Controls | 22 |
| Group | Value (Participants) |
|---|---|
| Pasireotide + Preparatory Regimen | 8 |
| Historical Controls | 11 |
| Group | Value (percentage of participants) |
|---|---|
| Pasireotide + Preparatory Regimen | 63 |
| Historical Controls | 82 |
| Group | Value (percentage of participants) |
|---|---|
| Pasireotide + Preparatory Regimen | 40 |
| Historical Controls | 78 |
| Group | Value |
|---|
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Pasireotide + Preparatory RegimenEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant. | 1 / 26 | 8 / 26 | 26 / 26 |
| Historical ControlsContemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome \[MDS\]/myeloproliferative neoplasm \[MPN\]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell \[PBPC\], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only). | 0 / 0 | 0 / 0 | 0 / 0 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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