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Brentuximab Vedotin

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brentuximab vedotin 0.3mg/kg, given IV on Days 7, 28, 49 \& 70

brentuximab vedotin 0.6mg/kg, given IV on Days 7, 28, 49 \& 70

brentuximab vedotin 1.2mg/kg, given IV on Days 7, 28, 49 \& 70

brentuximab vedotin 1.8mg/kg, given IV on Days 7, 28, 49 \& 70

The first 3 patients will not receive brentuximab vedotin.

brentuximab vedotin

Mark Schroeder, M.D.

This pilot clinical trial studies the safety and maximum tolerated dose of brentuximab vedotin when given with tacrolimus and methotrexate after unrelated allogeneic donor stem cell transplant in patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes. The addition of brentuximab vedotin to tacrolimus and methotrexate may result in a significant reduction of graft versus host disease in these patients.

Brentuximab Vedotin Prevention of (GVHD) After Unrelated Allogeneic Stem Cell Transplantation

A Pilot Study of Brentuximab Vedotin in the Prevention of Graft-Versus-Host Disease (GVHD) After Unrelated Allogeneic Stem Cell Transplantation

Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity; Hematologic DLT is defined as ANC \< 500/mm3 for three consecutive days beyond Day +21 that was determined by the investigator to be likely related to brentuximab vedotin.

Non-hematologic DLT is defined as any grade 3 or higher non-hematologic toxicity that was determined by the investigator to be possibly, probably, or definitely related to brentuximab vedotin, with the following specific exceptions:

* Grade 3 or 4 nausea, vomiting, diarrhea, mucositis, or fatigue thought to be associated with conditioning regimens
* Grade 3 rash will only be considered a DLT for patients who have received two weeks of supportive care treatment with no improvement.

Toxicities described and graded using CTCAE version 4.0; described by patient, type, and grade for each dose level; summarized by counts and percentage of patients in the corresponding categories

Proportion of all subjects who experience symptoms consistent with grade 2-4 acute GVHD; using the standard grading system adapted from the Glucksberg clinical stage and grade of acute GVHD

Proportion of all subjects who experience symptoms consistent with chronic GVHD; assessment will begin after Day 100 using the NIH consensus criteria for diagnosis and staging of chronic GVHD

Duration from the time of transplant to time of first progression, death, relapse after complete response, or the date the patient was last known to be in remission; estimated with Kaplan-Meier methods.

Duration from the time of transplant to death or last follow-up; estimated with Kaplan-Meier methods.

Defined as the percentage of patients dying from etiologies other than disease relapse; estimated with Kaplan-Meier methods.

Defined as the percentage of patients who have disease relapse; estimated with Kaplan-Meier methods.

Spots Global Cancer Trial Database for leukemia, lymphoblastic,acute