NCT00003335

Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer

A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With High Risk Hematologic Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 54 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells. PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer.

Detailed description

OBJECTIVES: * Determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies who are undergoing high dose chemoradiotherapy followed by unrelated umbilical cord blood (UCB) transplantation. * Determine the incidence of graft-versus-host-disease in this setting. * Describe the incidence of recurrent disease in these patients post UCB transplant. * Describe the incidence of serious infections and secondary lymphoproliferative diseases following transplantation with UCB in these patients. * Determine specifically whether larger recipients can be durably engrafted with unrelated UCB, and determine whether nucleated cell or progenitor cell content of the graft is predictive of hematological engraftment. OUTLINE: Patients may undergo a back-up peripheral blood stem cell collection prior to treatment. Patients receive 9 fractions of total body irradiation (TBI) on days -9 to -5 followed by melphalan IV for three days on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV for three days on days -3 to -1. On day 0, patients receive umbilical cord blood infusion. If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5. Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months. Patients are followed at least monthly for 1 year, then every 6 months for the second year, and then annually thereafter. PROJECTED ACCRUAL: There will be a maximum of 48 patients accrued into this study over 4 years.

Conditions

• Graft Versus Host Disease
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin	antithymocyte globulin IV for three days on days -3 to -1
DRUG	busulfan	If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5.
DRUG	cyclosporine	Cyclosporine begin on day -2 and continue for 6 months.
DRUG	melphalan	melphalan IV for three days on days -4 to -2
DRUG	methylprednisolone	Methylprednisolone IV for three days on days -3 to -1. Methylprednisolone begin on day -2 and continue for 6 months.
PROCEDURE	umbilical cord blood transplantation	On day 0, patients receive umbilical cord blood infusion.
RADIATION	radiation therapy	9 fractions of total body irradiation (TBI) on days -9 to -5

Timeline

• Start date: 1998-01-01
• Primary completion: 2007-11-01
• Completion: 2012-01-01
• First posted: 2003-01-27
• Last updated: 2012-03-15

Locations

1 site across 1 country: United States