NCT01408563

Reduced Intensity Double Umbilical Cord Blood Transplantation

A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.

Detailed description

Subjects will receive their transplants as in-patients. * IV-Catheter * one or two IV catheters will be placed on the day of hospital admission * Conditioning * Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2) * Melphalan IV (day -1) * Total body radiation on day 0 (same day as transplant) * Immunosuppressive Therapy * Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant. Given IV as in-patient, orally as out-patient * Infusion of Cord Blood units * 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be provided

Conditions

• Non-Hodgkin's Lymphoma
• Hodgkin's Lymphoma
• Multiple Myeloma
• Chronic Lymphocytic Leukemia
• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Fludarabine	30 mg/m2/day IV x 6 days
DRUG	Melphalan	100 mg/m2/day IV x 1 day
RADIATION	Total Body Radiation	200 cGy on Day 0
BIOLOGICAL	Cord Blood	2 cord blood units IV

Timeline

• Start date: 2011-12-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2011-08-03
• Last updated: 2019-01-23
• Results posted: 2018-11-21

Locations

3 sites across 1 country: United States