Allogeneic Stem Cell Transplantation for Patients With Hematological Malignancies Using Multiple Unrelated Cord Blood Units
OBJECTIVES:
Primary
- To determine the survival at day 100 of patients with relapsed, refractory, or
poor-risk hematological malignancies treated with four different preparative regimens
followed by allogeneic hematopoietic stem cell transplantation (HSCT) using two
unrelated umbilical cord blood (UCB) units.
Secondary
- To determine the incidence and timing of neutrophil engraftment in patients treated
with these regimens.
- To determine the incidence and timing of platelet engraftment in patients treated with
these regimens.
- To determine the incidence and severity of acute and chronic graft-versus-host-disease
(GVHD) in patients treated with these regimens.
- To determine the survival at day 180 in patients treated with these regimens.
- To determine the disease-free survival in patients treated with these regimens.
- To determine the incidence of primary and secondary engraftment failure in patients
treated with these regimens.
- To determine the incidence of transplantation-related complications (e.g., infection,
veno-occlusive disease of the liver, or organ toxicity) in these patients.
- To determine the incidence of post-transplantation-related lymphoproliferative disease,
secondary myelodysplastic syndromes, or other secondary malignancies in these patients.
- To determine the incidence of relapse in patients treated with these regimens.
- To determine post-transplantation chimerism in patients treated with these regimens.
- To determine immune reconstitution in patients treated with these regimens.
OUTLINE: This is a multicenter study.
- Preparative regimens: Patients are assigned to 1 of 4 preparative regimens.
- Regimen 1 (for patients < 50 years of age and no contraindication to fractionated
total-body irradiation (FTBI): Patients undergo FTBI 2-3 times a day on days -9 to
-6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2
hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2.
- Regimen 2 (for patients < 50 years of age and unable to tolerate FTBI due to prior
dose-limiting radiotherapy or significant cardiotoxicity): Patients receive a test
dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on
days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on
days -5 to -2.
- Regimen 3* (for patients unable to tolerate regimen 1 or 2; no age exclusion):
Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV
over 2 hours on day -3 and undergo TBI (single dose) on day -2.
- Regimen 4* (for patients unable to tolerate regimen 1 or 2): Patients receive
fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2.
NOTE: *Treating physician decides the choice between regimen 3 and 4
- Umbilical cord blood (UCB) transplantation: Patients receive 2 combined units of UCB IV
on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or
later) and continuing until blood counts recover.
- Graft-versus-host-disease prophylaxis: Patients receive cyclosporine IV twice daily
beginning on day -1 followed by a taper according to institutional guidelines. Patients
also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until
day 27 (or as clinically indicated).
After completion of study therapy, patients are followed periodically.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival at day 100 after allogeneic hematopoietic stem cell transplantation (HSCT) from umbilical cord blood (UCB)
Day 100
No
Joseph Rosenthal, MD
Principal Investigator
Beckman Research Institute
United States: Institutional Review Board
02165
NCT00547196
August 2003
Name | Location |
---|---|
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Banner Good Samaritan Medical Center | Phoenix, Arizona 85006 |