Trial Outcomes & Findings for Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies (NCT NCT01203722)

Race and Ethnicity were not collected from any participant.

Two immunosuppressive regimens with Fludarabine-Cytoxan-TBI conditioning will be studied in reduced-intensity, partially HLA mismatched allogeneic BMT from unrelated or non-first-degree related donors. Transplant regimen will be determined by acceptable rates of severe acute GVHD (\< 25%).

Two immunosuppressive regimens with Fludarabine-Cytoxan-TBI conditioning will be studied in reduced-intensity, partially HLA mismatched allogeneic BMT from unrelated or non-first-degree related donors. Transplant regimen will be determined by acceptable number of participants with transplant-related NRM.

Number of participants who do not have grade II-IV GVHD or evidence of graft failure will be assessed.

All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression.

All patients will be tracked from Day 0 to date of first observed disease progression, or death from any cause, or last patient evaluation. Patients will be followed on study to identify instances of death, progression or disease recurrence.

All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression.

All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression.

All patients will be tracked from Day 0 to date of first observed disease relapse or progression, or death from disease, or last patient evaluation. Patients who have not progressed or died by their last patient contact visit will be censored at the last date they were assessed and deemed free of relapse or progression.

All suspected cases of acute GVHD must be confirmed histologically by biopsy of an affected organ (skin, liver, or gastrointestinal tract). Date of symptom onset, date of biopsy confirmation of GVHD, maximum clinical grade, and dates and types of treatment will be recorded. Dates of symptom onset of grade II or higher GVHD and grade III-IV GVHD will be recorded.

All suspected cases of acute GVHD must be confirmed histologically by biopsy of an affected organ (skin, liver, or gastrointestinal tract). Date of symptom onset, date of biopsy confirmation of GVHD, maximum clinical grade, and dates and types of treatment will be recorded. Dates of symptom onset of grade II or higher GVHD and grade III-IV GVHD will be recorded.

All suspected cases of acute GVHD must be confirmed histologically by biopsy of an affected organ (skin, liver, or gastrointestinal tract). Date of symptom onset, date of biopsy confirmation of GVHD, maximum clinical grade, and dates and types of treatment will be recorded. Dates of symptom onset of grade II or higher GVHD and grade III-IV GVHD will be recorded.

Number of cases with less than 5% donor chimerism in blood and/or bone marrow on \~Day 30 or after and on all subsequent measurements, in the absence of documented bone marrow involvement by malignancy.

Number of cases who achieve a post nadir ANC greater or equal to 500/mm3 for three consecutive measurements on different days.

Number of cases who achieve a platelet count greater than 20,000/mm3 or greater than 50,000/mm3 with no platelet transfusions in the preceding seven days, as measured as maintained on at least three consecutive measurements on different days.

Number of cases who achieve either mixed donor chimerism is defined as greater than 5%, but less than 95%, donor or full donor chimerism is defined as \> 95% donor.

Number of cases who reach the end of the trial without severe acute (grade III-IV) GVHD, graft failure, or non-relapse mortality