Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

Tracking Information
First Submitted Date ICMJE	September 11, 2009
First Posted Date ICMJE	September 14, 2009
Results First Submitted Date	January 28, 2016
Results First Posted Date	February 26, 2016
Last Update Posted Date	February 26, 2016
Study Start Date ICMJE	September 2009
Actual Primary Completion Date	October 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 28, 2016)	Grade 3-4 Acute GVHD Rate [ Time Frame: Transplant (Day 0) up to 1 year ]; The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD
Original Primary Outcome Measures ICMJE; (submitted: September 11, 2009)	Assess the incidence grade 3-4 aGVHD; Compare the incidence of grade 3-4 aGVHD with those of a recently completed clinical trial cohort [ Time Frame: Pre-Transplant thru 1 year post transplant ]
Change History	Complete list of historical versions of study NCT00975975 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 28, 2016)	Time to Neutrophil Engraftment [ Time Frame: Transplant (Day 0) up to 1 year ]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 to Platelet Engraftment [ Time Frame: Transplant (Day 0) up to 1 year ]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.
Original Secondary Outcome Measures ICMJE; (submitted: September 11, 2009)	To test the hypothesis that donor cell engraftment is associated with an expansion of donor-derived natural killer cells in the immediate post-transplant period [ Time Frame: Pre-transplant thru 1 year post-transplant ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
Official Title ICMJE	Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent GVHD After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
Brief Summary	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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Myelodysplasia; Non-Hodgkin's Lymphoma; Hodgkin's Disease; Multiple Myeloma; Myelofibrosis; Anemia, Aplastic; Hemoglobinuria, Paroxysmal
Intervention ICMJE	Drug: Basiliximab; Basiliximab given 1 time on Day +7 or Day +9.; Other Name: Simulect
Study Arms	Experimental: Basiliximab; 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.; Intervention: Drug: Basiliximab
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 15, 2012)	17
Original Estimated Enrollment ICMJE; (submitted: September 11, 2009)	10
Actual Study Completion Date	November 2013
Actual Primary Completion Date	October 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Acute myelogenous leukemia: Second or subsequent remission; patient over 18 yrs of age. Relapsed after autologous HC transplant, over 18 years of age. First remission, Philadelphia chromosome + over age 18. Secondary AML, in first or subsequent remissions.; Acute lymphocytic leukemia: Philadelphia chromosome + over the age of 50, first or subsequent remission. Relapse following Autologous HC transplantation, ages over 50. Second or subsequent remission over the age of 50; Chronic myelogenous leukemia: First or second chronic phase over the age of 18. Accelerated phase over the age of 18. Must have failed or been intolerant to a standard tyrosine kinase inhibitor.; Chronic lymphocytic leukemia: Failed nucleoside-based therapy, ages >18.; Myelodysplasia: All-risk categories, age greater than 18.; Non-Hodgkin's Lymphoma, less than 76 years of age Relapsed diffuse aggressive NHL (intermediate and high grade) that fails to achieve CR or PR to conventional salvage chemotherapy. Aggressive NHL includes diffuse large B cell lymphoma, diffuse mixed small and large cell lymphoma, follicular lymphoma for grade 3 (follicular large cell lymphoma), T or B cell lymphoblastic lymphoma, diffuse small noncleaved (Burkett's or Burkett-like ) lymphoma, mantle cell lymphoma, peripheral T cell lymphoma, anaplastic large cell lymphoma, and other diffuse aggressive lymphomas that are not otherwise classifiable Aggressive NHL that has relapsed following autologous HCT. Patients that respond to additional treatment for post-transplant relapse are eligible. Aggressive NHL that does not achieve CR or PR with primary chemotherapy (i.e., primary induction failure). Low-grade lymphoma refractory to standard therapy, including the following: small cell lymphocytic lymphoma, follicular lymphoma of grades 1 and 2 (follicular small cleaved and follicular mixed small and large cell lymphoma) marginal cell lymphoma, splenic lymphoma), lymphoplasmacytic lymphoma and other lymphomas not otherwise classifiable.; Patients with low-grade lymphoma must have experienced progressive disease after receiving three or more of the following regimens: alkylator-based therapy (cyclophosphamide/ vincristine/ prednisone) chlorambucil, monoclonal antibody based therapy (e.g., rituximab, Campath-1H, radiolabelled CD20+ antibodies); nucleoside analog-based therapy (e.g., fludarabine, cladribine).); Patients with marginal zone lymphoma or gastric MALT type associated with Helicobacter pylori infection must have progressed after receiving appropriate antibiotic therapy as well as three or more regimens as described above; Mantle cell, ages 18-75.; Hodgkin's Disease, ages 18-75. Relapsed or refractory disease after autologous transplant.; Multiple Myeloma, ages 18-75 Recurrent disease after two medical therapies Relapse following autologous transplant; Myelofibrosis, age greater than 18 years; 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: Absolute granulocyte count <500/mm3 Corrected reticulocyte count <1% Untransfused platelet count <20,000/mm3 on at least 2 occasions Hemoglobin <9 g/dL (adults) or < 8 g/dL (children) on at least 2 occasions; Paroxysmal nocturnal hemoglobinuria; age greater than 18 years. Renal function: creatinine greater than 2.5; Donor Requirement: Must have a fully HLA-matched (10 of 10 Antigen matched) 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.; Inability to give informed consent.; AST, ALT, total bilirubin >3x upper limit of normal.; Creatinine > 2 or creatinine clearance < 50mL/hr. If patient has a creatinine of > 2 or creatinine clearance < 50mL/hr and it is due to the disease process then the patient will not be excluded based on this.; Fractional shortening by echocardiogram not within normal limits per institution or LVEF of < 40 %.; Pulmonary function: DLCO not within institutional normal limits or DLCO less than 45% of normal predicted, corrected for anemia; Prior allogeneic transplant.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00975975
Other Study ID Numbers ICMJE	0908-04; IUCRO-0256
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Indiana University ( Indiana University School of Medicine )
Study Sponsor ICMJE	Indiana University School of Medicine
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Robert Nelson, MD Indiana University School of Medicine
PRS Account	Indiana University
Verification Date	January 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP