Baseline characteristics

Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease · Source last updated 2017-05-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

1. counts

   1. group Id

      BG000

      value

      71

   units

   Participants

groups

1. description

   All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).

   id

   BG000

   title

   All Trial Participants

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            28

            upper Limit

            69

            value

            58

   dispersion Type

   FULL_RANGE

   param Type

   MEDIAN

   title

   Age, Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            31

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            40

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            1

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            0

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            9

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            60

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            0

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            1

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            71

      title

      United States

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

5. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            37

      title

      HLA-matched related donor (MRD)

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            34

      title

      MUD or HLA-mismatched grafts

   description

   Human leukocyte antigen (HLA) typing is used to match a recipient with a donor for bone marrow or cord blood transplant. Donor types are either HLA-matched related donor (MRD) or matched unrelated donor (MUD) or HLA-mismatched grafts.

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Donor Types

   unit Of Measure

   Participants

6. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            0

            upper Limit

            8

            value

            3

   description

   The Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) was developed to identify relevant comorbidities in the allogeneic stem cell transplantation population and to enable risk assessment before allogeneic transplant. Comorbidities are given a a weighted score of 1 to 3 if present. The total score can range from 0 to 29, with higher numbers indicating more/worse comorbidities. The HCT-CI scores were further collapsed into 3 risk groups: 0 (low risk), 1 to 2 (intermediate risk), and 3 or more (high risk).

   dispersion Type

   FULL_RANGE

   param Type

   MEDIAN

   title

   Comorbidity Index (CI)

   unit Of Measure

   units on a scale

7. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            9

      title

      Low

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            40

      title

      Intermediate

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            19

      title

      High

   4. categories

      1. measurements

         1. group Id

            BG000

            value

            1

      title

      Very High

   5. categories

      1. measurements

         1. group Id

            BG000

            value

            2

      title

      Undetermined

   description

   The DRI uses a combination of a ternary breakdown for disease type and a binary breakdown for remission status to assign patients to 1 of 4 risk categories that differ very significantly (statistically and clinically) with respect to overall survival (OS) and Progression free survival (PFS).

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Disease Risk Index (DRI)

   unit Of Measure

   Participants

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Preserved source evidence · Not medical advice