Cancer

Title
A Randomized Study Comparing the Placebo or Study Drug Plus the Standard Medication that is Used to Prevent Moderate to Severe Chronic Graft Vs. Host Disease in Adult Participants with Acute Myeloid Leukemia, Acute Lymphoid Leukemia or Myelodysplastic Syndrome after Allogeneic Stem Cell Transplantation from Unrelated Donors.
Trial Number
203992111611
Number of Participants
250
Principal Investigator

Patrick Stiff

M.D.
Hematology/Oncology
Coleman Professor of Oncology
Eligibility

1. Participants designated to undergo allogeneic peripheral blood or bone marrow stem cell transplantation following the diagnosis of
one of the following primary diseases in early or intermediate
disease status:
- Acute myeloid leukemia (AML) at the following stages: 1st
remission, 2nd remission and 3rd or subsequent remission
- Acute lymphoid leukemia (ALL) at the following stages: 1st
remission, 2nd remission and 3rd or subsequent remission
- Myelodysplastic syndrome (MDS) (FAB classification
types RA, RARS, RAEB-1)
2. Patients with an unrelated HLA-A, -B, -C and -DRB1 matched
(all by high resolution typing) donor (8 out of 8 alleles).
3. Patients with a Karnofsky Performance Score (KPS) = 70%.

Purpose

The primary reason for this study is to test the effect of the study drug or placebo when combined with the standard preventive drugs for Graft Vs. Host Disease (GVHD).

Enrollment

(708) 327-2241

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