Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
Completed
National Cancer Institute (NCI)
Phase 3
2002-04-01
RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in
preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing
cytomegalovirus in patients undergoing stem cell transplantation.
PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in
preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.
Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
Completed
Fred Hutchinson Cancer Research Center
Phase 3
2002-04-01
RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in
preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing
cytomegalovirus in patients undergoing stem cell transplantation.
PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in
preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.
Busulfan Plus Cyclophosphamide vs Fludarabine as a Conditioning Regimen
Completed
Cooperative Study Group A for Hematology
Phase 3
2002-05-01
1. At the same time of registration, patients will be randomized to one of the two
conditioning therapy groups; Arm I (intravenous busulfan plus cyclophosphamide; BuCy) or
Arm II (intravenous busulfan plus fludarabine; BuFlu).
2. Randomization will be a stratified permuted-block design. 2.1The patients will be
stratified into standard risk vs. high risk group, and related vs. unrelated donor.
Standard risk group will be defined as follows: patients with acute leukemia in first
remission, CML in chronic phase, and MDS (RA or RARS categories). High risk group will
be defined as follows: patients with acute leukemia in relapse or in second or
subsequent remission, CML in accelerated or blastic phase, and MDS (CMMoL or RAEB
categories).
2.2.Pre-assigned block size is 8.
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