NCT00873093 · OUTCOME

Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2

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: End of Block 2 (Day 36 of Block 2) of re-induction therapy

What was measured

Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 2.

Analysis population: The MRD analysis is limited to eligible and evaluable pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3.

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

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

T-cell ALL (Chemotherapy)

T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

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

Analysis denominator · Participants

Group	Source count
Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs	0
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs	30
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs	19
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
Group	Value	Spread	Lower	Upper	Comment
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs	66.7	Not reported	Not reported	Not reported	Not reported
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs	42.1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG001
value
66.7
group Id
OG002
value
42.1

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
30
group Id
OG002
value
19
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants

description

Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 2.

groups

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
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
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
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)
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 MRD analysis is limited to eligible and evaluable pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3.

reporting Status

POSTED

time Frame

End of Block 2 (Day 36 of Block 2) of re-induction therapy

title

Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice