Acute Lymphocytic Leukemia, Acute Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Hodgkin's Disease, Lymphoma, Non-Hodgkin's, Mantle-Cell Lymphoma, Multiple Myeloma, Myelodysplasia, Myelofibrosis
Conditions
Brief summary
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease. This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative (mini transplant).
Interventions
DRUGCyclophosphamide
60mg/kg/day for two consecutive days (-7,-6).
DRUGFludarabine
25mg/m2/day for 5 consecutive days
DRUGCyclosporine
3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1.
DRUGMycophenolate mofetil
1000 mg will be administered through day +60 and then discontinued if there is no GVHD.
DRUGBasiliximab
20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.
Sponsors
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility requirements as outlined in the protocol * Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis.
Exclusion criteria
* Active CNS disease (the presence of leukemic blasts in the CSF) * Pregnancy or breast-feeding * SGOT \>3x upper limit of normal * Creatinine \>2 or creatinine clearance \<50cc/hr. * Fractional shortening by echocardiogram not within normal limits per institution * Pulmonary function: DLCO less that 50% of normal predicted, corrected for anemia * Prior allogeneic transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Acute Grade II-IV GVHD | until 30 days after stem cell transplant | Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's). | until 30 days after stem cell transplant | — |
| Number of Days for Absolute Neutrophil Count to Recover | From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion) | Average number of day per patient for absolute neutrophil count to recover(\> 500/mm3 for 3 consecutive days). |
| Time to Resolution of Cytopenias: Platelet Transfusion Independence | From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion) | Average number of days per patient for resolution of cytopenias. |
| Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria. | up to 2 years after stem cell transplant | Number of patients who died due to transplant related toxicities |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Basiliximab 20 mg All patients that received Basiliximab 20 mg monoclonal therapy | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Basiliximab 20 mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 52.80 years STANDARD_DEVIATION 11.29 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 4 / 10 |
Outcome results
Primary
Number of Patients With Acute Grade II-IV GVHD
Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.
Time frame: until 30 days after stem cell transplant
Population: All patient that received study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Basiliximab 20 mg | Number of Patients With Acute Grade II-IV GVHD | 10 participants |
Secondary
Number of Days for Absolute Neutrophil Count to Recover
Average number of day per patient for absolute neutrophil count to recover(\> 500/mm3 for 3 consecutive days).
Time frame: From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)
Population: ITT: All patient that received study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basiliximab 20 mg | Number of Days for Absolute Neutrophil Count to Recover | 14.00 days per patient | Standard Deviation 3.8 |
Secondary
Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
Time frame: until 30 days after stem cell transplant
Population: ITT population. All patient that received study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Basiliximab 20 mg | Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's). | 10 participants |
Secondary
Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.
Number of patients who died due to transplant related toxicities
Time frame: up to 2 years after stem cell transplant
Population: Intent To Treat: All patients that received study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Basiliximab 20 mg | Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria. | 10 participants |
Secondary
Time to Resolution of Cytopenias: Platelet Transfusion Independence
Average number of days per patient for resolution of cytopenias.
Time frame: From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)
Population: IIT: All patients that received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basiliximab 20 mg | Time to Resolution of Cytopenias: Platelet Transfusion Independence | 15.33 days per patient | Standard Deviation 3.54 |