Baseline characteristics

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2021-06-14

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

      5377

   units

   Participants

groups

1. description

   All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study. cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT vincristine sulfate: Given IV

   id

   BG000

   title

   Group 0 Induction Therapy

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            5377

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            0

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            0

         title

         >=65 years

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Age, Categorical

   unit Of Measure

   Participants

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            2.10

            value

            4.45

   dispersion Type

   STANDARD_DEVIATION

   param Type

   MEAN

   title

   Age, Continuous

   unit Of Measure

   years

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            2489

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            2888

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            1097

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            4038

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            242

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Ethnicity (NIH/OMB)

   unit Of Measure

   Participants

5. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            36

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            253

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            24

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            326

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            4046

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            0

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            692

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

6. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            5377

      title

      United States

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

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Preserved source evidence · Not medical advice