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NCT00004228 · OUTCOME

Event-free Survival

Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma · Source last updated 2019-08-06

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

Measure
NUMBER
Unit
percentage of particpants
Interval / dispersion
95% Confidence Interval
Time frame
5 years

What was measured

Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.

Analysis population: There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.

Groups in this outcome

A0 (Localized Disease Stg I/II) Modified CCG BFM

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)

A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)

A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)

B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)

B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)

B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)

B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)

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

Analysis denominator · Participants

GroupSource count
A0 (Localized Disease Stg I/II) Modified CCG BFM56
A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens64
A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens61
B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy12
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens66
B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens63
B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment52

Reported measurements

Source class 1
Values in percentage of particpants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
A0 (Localized Disease Stg I/II) Modified CCG BFM88Not reported7695Not reported
A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens82Not reported7090Not reported
A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens80Not reported6789Not reported
B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy63Not reported2985Not reported
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens82Not reported7089Not reported
B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens84Not reported7291Not reported
B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment90Not reported7896Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Description
    A Cox model was used to assess evidence of a difference in event-free survival comparing regimens A1+A2 ("A: CCG BFM") to regimens B1+B2 ("B: NHL/BFM-95") while adjusting for the other intervention through stratification.
    group Ids
    1. OG001
    2. OG002
    3. OG003
    4. OG005
    5. OG006
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .97
    statistical Method
    Regression, Cox
  2. ci Num Sides
    TWO_SIDED
    group Description
    A Cox model was used to assess evidence of a difference in event-free survival comparing A1+B1 ("1: no intensification") to A2 +B2 ("2: intensification"), while adjusting for the other intervention through stratification.
    group Ids
    1. OG001
    2. OG002
    3. OG003
    4. OG005
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .63
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    A Cox model was used to assess evidence of a difference in event-free survival comparing regimens A1+A2 ("A: CCG BFM") to regimens B1+B2 ("B: NHL/BFM-95") while adjusting for the other intervention through stratification.
    group Ids
    1. OG001
    2. OG002
    3. OG003
    4. OG005
    5. OG006
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .97
    statistical Method
    Regression, Cox
  2. ci Num Sides
    TWO_SIDED
    group Description
    A Cox model was used to assess evidence of a difference in event-free survival comparing A1+B1 ("1: no intensification") to A2 +B2 ("2: intensification"), while adjusting for the other intervention through stratification.
    group Ids
    1. OG001
    2. OG002
    3. OG003
    4. OG005
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .63
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        76
        upper Limit
        95
        value
        88
      2. group Id
        OG001
        lower Limit
        70
        upper Limit
        90
        value
        82
      3. group Id
        OG002
        lower Limit
        67
        upper Limit
        89
        value
        80
      4. group Id
        OG003
        lower Limit
        29
        upper Limit
        85
        value
        63
      5. group Id
        OG004
        lower Limit
        70
        upper Limit
        89
        value
        82
      6. group Id
        OG005
        lower Limit
        72
        upper Limit
        91
        value
        84
      7. group Id
        OG006
        lower Limit
        78
        upper Limit
        96
        value
        90
denoms
  1. counts
    1. group Id
      OG000
      value
      56
    2. group Id
      OG001
      value
      64
    3. group Id
      OG002
      value
      61
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      66
    6. group Id
      OG005
      value
      63
    7. group Id
      OG006
      value
      52
    units
    Participants
description
Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.
dispersion Type
95% Confidence Interval
groups
  1. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
    id
    OG000
    title
    A0 (Localized Disease Stg I/II) Modified CCG BFM
  2. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
    id
    OG001
    title
    A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens
  3. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    id
    OG002
    title
    A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens
  4. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    id
    OG003
    title
    B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy
  5. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    id
    OG004
    title
    B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens
  6. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    id
    OG005
    title
    B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens
  7. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    id
    OG006
    title
    B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment
param Type
NUMBER
population Description
There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.
reporting Status
POSTED
time Frame
5 years
title
Event-free Survival
type
PRIMARY
unit Of Measure
percentage of particpants

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

Preserved source evidence · Not medical advice