NCT00054236

Combination Chemotherapy Followed By Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Severe Aplastic Anemia

Pilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic Anemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by umbilical cord blood transplantation in treating patients who have hematologic cancer or severe aplastic anemia.

Detailed description

OBJECTIVES: * Determine the incidence and severity of acute toxicity in patients with hematologic malignancies or severe aplastic anemia treated with a non-myeloablative conditioning regimen followed by umbilical cord blood transplantation. * Determine the incidence and severity of acute and chronic graft-versus-host-disease in patients treated with this regimen. * Determine the incidence of relapse, disease-free survival, and overall survival of patients treated with this regimen. * Determine the survival rate at 100 days post-transplantation in patients treated with this regimen. * Determine the incidence of regimen-related complications (infection, hepatic veno-occlusive disease, and interstitial pneumonitis) in patients treated with this regimen. * Determine the incidence of primary and secondary graft failure in patients treated with this regimen. * Determine the rates and kinetics of donor-derived lymphoid, myeloid, neutrophil, RBC, and platelet engraftment in patients treated with this regimen. OUTLINE: Patients receive a non-myeloablative conditioning regimen comprising fludarabine IV over 30 minutes on days -8 to -4, cyclophosphamide IV over 2 hours on days -3 to -2, and anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1. Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1. Patients undergo multiple unit umbilical cord blood transplantation on days 0-1. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover. Patients are followed monthly for 6 months; at 9, 12, 14, 16, 18, and 24 months; and then annually thereafter. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin	anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1
BIOLOGICAL	filgrastim	Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.
DRUG	cyclophosphamide	cyclophosphamide IV over 2 hours on days -3 to -2
DRUG	fludarabine phosphate	fludarabine IV over 30 minutes on days -8 to -4
PROCEDURE	umbilical cord blood transplantation	Patients undergo multiple unit umbilical cord blood transplantation on days 0-1.
DRUG	methylprednisolone	Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.

Timeline

• Start date: 2002-05-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2003-02-06
• Last updated: 2020-07-27

Locations

1 site across 1 country: United States