Cancer Clinical Trial
Official title:
Conditioning for Graft Failure After Hematopoietic Stem Cell Transplantation
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.
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