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NCT00873093 · OUTCOME

Plasma Concentration-time Profiles

Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma · Source last updated 2017-01-27

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to day 8 of block 2

What was measured

Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).

Analysis population: These were for correlative biology studies and the data were not collected in COG database.

Groups in this outcome

Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \& 29 Block 2: Days 1 \& 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \& 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \& 11 Block 2: Days 1, 4 \& 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \& 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \& 29 Block 2: Days 1 \& 22 etopo

Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 \& 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \& 29 Block 2: Days 1 \& 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \& 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \& 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \& 11 Block 2: Days 1, 4 \& 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \& 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \& 29 Block 2: Days 1 \& 22 etopo

Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 \& 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \& 29 Block 2: Days 1 \& 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \& 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \& 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \& 11 Block 2: Days 1, 4 \& 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \& 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \& 29 Block 2: Days 1 \& 22 etopo

T-cell ALL (Chemotherapy)

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 \& 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \& 29 Block 2: Days 1 \& 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \& 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \& 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \& 11 Block 2: Days 1, 4 \& 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \& 22 methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \& 29 Block 2: Days 1 \& 22 etopo

T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 \& 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \& 29 Block 2: Days 1 \& 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \& 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \& 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \& 11 Block 2: Days 1, 4 \& 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \& 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \& 29 Block 2: Days 1 \& 22 etopo

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs0
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs0
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs0
T-cell ALL (Chemotherapy)0
T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    units
    Participants
description
Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).
groups
  1. description
    Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \& 29 Block 2: Days 1 \& 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \& 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \& 11 Block 2: Days 1, 4 \& 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \& 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \& 29 Block 2: Days 1 \& 22 etopo
    id
    OG000
    title
    Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs
  2. description
    Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 \& 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \& 29 Block 2: Days 1 \& 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \& 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \& 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \& 11 Block 2: Days 1, 4 \& 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \& 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \& 29 Block 2: Days 1 \& 22 etopo
    id
    OG001
    title
    Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs
  3. description
    Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 \& 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \& 29 Block 2: Days 1 \& 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \& 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \& 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \& 11 Block 2: Days 1, 4 \& 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \& 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \& 29 Block 2: Days 1 \& 22 etopo
    id
    OG002
    title
    Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs
  4. description
    Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 \& 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \& 29 Block 2: Days 1 \& 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \& 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \& 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \& 11 Block 2: Days 1, 4 \& 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \& 22 methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \& 29 Block 2: Days 1 \& 22 etopo
    id
    OG003
    title
    T-cell ALL (Chemotherapy)
  5. description
    Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 \& 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \& 29 Block 2: Days 1 \& 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \& 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \& 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \& 11 Block 2: Days 1, 4 \& 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \& 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \& 29 Block 2: Days 1 \& 22 etopo
    id
    OG004
    title
    T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
population Description
These were for correlative biology studies and the data were not collected in COG database.
reporting Status
POSTED
time Frame
Up to day 8 of block 2
title
Plasma Concentration-time Profiles
type
OTHER_PRE_SPECIFIED

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice