A Phase 2 interventional study of Basiliximab in Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia and Chronic Myelogenous Leukemia, sponsored by Indiana University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-26.
Sponsored by Indiana University School of Medicine · Phase 2, Interventional, and Treatment
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues.
This study is for patients with a blood condition or myelodysplasia (bone marrow disease) which has either not responded to treatment or is not treatable by conventional/routine medical treatments. Bone marrow transplantation is a medical treatment that involves giving high doses of chemotherapy followed by the transplantation of the blood-forming and immune cells from a relative or from a "matched" unrelated person through the National Marrow Donor Program, in an attempt to cure disease in the recipient (the person receiving the donated cells). Nonmyeloablative (bone-marrow preservation) bone marrow transplantation is a relatively new technique in which lower than usual doses of chemotherapy are given before transplantation, in hopes of reducing adverse side effects of the chemotherapy in transplant patients. Nonmyeloablative bone marrow transplantation has several advantages which doctors have determined are beneficial for this condition.
This research is being done because the complication of graft-versus-host disease can be bad for a person and there is no completely safe and effective way to prevent this complication. We know that cyclosporine helps but would like to know if the addition of basiliximab, given with cyclosporine, will decrease the incidence and/or severity of graft-versus-host disease after a transplant known as nonmyeloablative or "mini" transplant.
5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 17 is below the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.
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Acute myelogenous leukemia:
Acute lymphocytic leukemia:
Chronic myelogenous leukemia:
Chronic lymphocytic leukemia:
Myelodysplasia:
Non-Hodgkin's Lymphoma, less than 76 years of age
Low-grade lymphoma refractory to standard therapy, including the following:
Patients with low-grade lymphoma must have experienced progressive disease after receiving three or more of the following regimens:
Hodgkin's Disease, ages 18-75.
Multiple Myeloma, ages 18-75
Severe aplastic anemia (refractory to immunosuppressive therapy); age greater than 18 years
Patients with aplastic anemia must have marrow cellularity ≤ 10% plus 2 of the following:
Paroxysmal nocturnal hemoglobinuria; age greater than 18 years.
Donor Requirement:
Exclusion Criteria:
Basiliximab will be given by IV on Day +7 post transplant for recipients of matched unrelated cells. Basiliximab will be given by IV on Day +9 post transplant for recipients of matched related cells.
Drug: Basiliximab
Basiliximab given 1 time on Day +7 or Day +9.
Also known as: Simulect
Grade 3-4 Acute GVHD Rate
The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD
Time frame: Transplant (Day 0) up to 1 year
Time to Neutrophil Engraftment
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Time frame: Transplant (Day 0) up to 1 year
Time to Platelet Engraftment
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Time frame: Transplant (Day 0) up to 1 year
This protocol has 17 patients. The study was stopped prior to 20 due to the meeting of a stopping rule of 5 or more deaths within the first 15 patients. An additional patient was enrolled after the stopping rule was met. This patient was followed for safety/AE but is not included in the analysis of the efficacy measures, as recommended by the IRB.
| Milestone | Overall |
|---|---|
| Started | 17 |
| Completed | 11 |
| Not completed | 6 |
| Withdrew: Death | 6 |
The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD
| percentage of participants | Overall |
|---|---|
| Grade 3-4 Acute GVHD Rate | 29.4 (10.3 to 56.0) |
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
| days | Overall |
|---|---|
| Time to Neutrophil Engraftment | 13.5 (10.0 to 14.0) |
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
| days | Overall |
|---|---|
| Time to Platelet Engraftment | 12.0 (8.0 to 18.0) |
Collected over From transplant until the end of the study, for up to 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall | — | 7/17 (41.2%) | 17/17 (100%) |
| Event | Overall |
|---|---|
| INFECTION - OTHERInfections and infestations | 4/17 |
| DIARRHEAGastrointestinal disorders | 2/17 |
| PAIN - ABDOMEN NOSGastrointestinal disorders | 2/17 |
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)General disorders | 2/17 |
| INFECTION WITH UNKNOWN ANC - BLOODInfections and infestations | 2/17 |
| CREATININEInvestigations | 2/17 |
| HYPOXIARespiratory, thoracic and mediastinal disorders | 2/17 |
| CARDIAC ARRHYTHMIA - OTHERCardiac disorders | 1/17 |
| CONDUCTION ABNORMALITY/ATRIOVENTRICULAR HEART BLOCK - ASYSTOLECardiac disorders | 1/17 |
| GASTROINTESTINAL - OTHERGastrointestinal disorders | 1/17 |
| Event | Overall |
|---|---|
| DIARRHEAGastrointestinal disorders | 14/17 |
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)General disorders | 14/17 |
| BILIRUBIN (HYPERBILIRUBINEMIA)Hepatobiliary disorders | 14/17 |
| INFECTION - OTHERInfections and infestations | 14/17 |
| ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)Investigations | 14/17 |
| AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)Investigations | 14/17 |
| CREATININEInvestigations | 14/17 |
| EDEMA: LIMBMetabolism and nutrition disorders | 14/17 |
| ALKALINE PHOSPHATASEInvestigations | 12/17 |
| DYSPNEA (SHORTNESS OF BREATH)Respiratory, thoracic and mediastinal disorders | 12/17 |
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 59.1 ± 7.05 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 8 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | Overall |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Indiana University School of Medicine