NCT00617929

Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant

Conditioning for Graft Failure After Hematopoietic Stem Cell Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin	administer 3 mg/kg intravenously (IV) over 4 hours on days -6, -5 and -4.
BIOLOGICAL	rituximab	administered 375 mg/m\^2 intravenously (IV) in 1 mg/mL normal saline on day -7.
DRUG	clofarabine	administered 30 mg/m\^2 intravenously (IV) over 1 hour on Days -4, -3, and -2.
PROCEDURE	stem cell transplantation	administered on Day 0 per institutional guidelines.

Timeline

• Start date: 2008-01-01
• Primary completion: 2014-10-01
• Completion: 2015-10-01
• First posted: 2008-02-18
• Last updated: 2017-12-28
• Results posted: 2017-01-20

Locations

1 site across 1 country: United States