RATIONALE: Antithymocyte globulin, clofarabine, and rituximab may stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with clofarabine and rituximab works in treating patients after an unsuccessful stem cell transplant.
OBJECTIVES: Primary * To determine the rate of sustained donor engraftment at 42 days and survival at 100 days post transplantation in patients treated with anti-thymocyte globulin, clofarabine, and rituximab. Secondary * To determine incidence of treatment-related mortality at day 100 post transplantation. * To determine incidence of neutrophil recovery by day 42 post transplantation. * To determine survival at day 100 and 1 year post transplantation. * To determine the proportion of patients with chimerism at day 28 post transplantation. * To determine incidence and severity of grades II-IV acute graft-vs-host disease by day 100 post transplantation. OUTLINE: * Conditioning regimen: Patients receive rituximab intravenously (IV) on day -7, anti-thymocyte globulin IV over 4-6 hours on days -6 to -4, and clofarabine IV over 1 hour on days -4 to -2. * Hematopoietic stem cell transplantation (HSCT): Patients undergo HSCT on day 0. Patients may receive umbilical cord blood, peripheral blood stem cells, or bone marrow from unrelated or related donors. * Graft-vs-host disease (GVHD) prophylaxis: Patients receive oral cyclosporine twice daily or cyclosporine IV every 8 hours beginning on day -3 and continuing for 100 or 180 days post transplantation followed by a taper; mycophenolate mofetil IV every 8 hours beginning on day -3 and continuing for 30 days (or 7 days after engraftment with no evidence of GVHD); and filgrastim (G-CSF) IV once daily beginning on day 1 and continuing until blood counts recover. After completion of study therapy, patients are followed on days 100, 180, and 360.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
administer 3 mg/kg intravenously (IV) over 4 hours on days -6, -5 and -4.
administered 375 mg/m\^2 intravenously (IV) in 1 mg/mL normal saline on day -7.
administered 30 mg/m\^2 intravenously (IV) over 1 hour on Days -4, -3, and -2.
administered on Day 0 per institutional guidelines.
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Rate of Sustained Donor Engraftment
Rate of Sustained Donor Engraftment is defined as the percent of paticipants with an absolute neutrophile count (ANC) of 500 or more without a subsequent graft rejection.
Time frame: Day 42 post transplantation
Survival at 100 Days Post Transplant
Percent of patients alive from beginning of study to Day 100 post transplantation
Time frame: Day 100 post transplantation
Treatment-related Death
Percent of patients who died related to the treatment in this study.
Time frame: Day 100 post transplantation
Time to Primary Neutrophil Engraftment
Time to primary neutrophil engraftment is defined as the percent of patients with an absolute neutrophil count (ANC) of 500 or more neutrophils in a cubic millimeter of blood.
Time frame: Day 42 post transplantation
Survival
Percent of patients alive from beginning of study to one year post transplantation
Time frame: One year post transplantation
Chimerism
Occurrence of genetically distinct cell types in a single organism
Time frame: Day 28 post transplantation
Acute Graft-vs-host Disease
Percent of patients with Acute Graft-vs-host Disease - a process where T-cells present in the donor's bone marrow at the time of transplant identify the transplant patient as "non-self' and attack the patient's skin, liver, stomach, and/or intestines.
Time frame: Day 30-100
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