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NCT00873093 · OUTCOME

Event Free Survival

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
4 months after enrollment

What was measured

Percentage of patients who were event free at 4 months

Analysis population: The analysis on this primary outcome is limited to pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) per protocol section 9.2.1.

Groups in this outcome

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

Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.

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

Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.

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

Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.

T-cell ALL (Chemotherapy)

Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.

T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.

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 Yrs54
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs46
T-cell ALL (Chemotherapy)0
T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)0

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs68.5Not reportedNot reportedNot reportedNot reported
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs37.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        68.5
      2. group Id
        OG002
        value
        37.8
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      54
    3. group Id
      OG002
      value
      46
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    units
    Participants
description
Percentage of patients who were event free at 4 months
groups
  1. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    OG000
    title
    Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs
  2. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    OG001
    title
    Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs
  3. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    OG002
    title
    Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs
  4. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    OG003
    title
    T-cell ALL (Chemotherapy)
  5. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    OG004
    title
    T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
param Type
NUMBER
population Description
The analysis on this primary outcome is limited to pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) per protocol section 9.2.1.
reporting Status
POSTED
time Frame
4 months after enrollment
title
Event Free Survival
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice