NCT00096135 · OUTCOME

Event-free Survival

Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes · Source last updated 2017-03-21

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: 3 years

What was measured

Monitoring of efficacy results will be performed in comparison with historical results.

Analysis population: The CNS-treatment cohort includes 126 patients with 120 CNS pre-B, 2 CNS+ITR pre-B and 4 T-AL. The primary analysis was restricted to CNS pre-B and ITR pre-B patients, respectively. Both CNS+ITR and T-ALL patients had to be excluded from the primary analysis. That is how we came to 120 in the CNS-treatment cohort for outcome analysis.

Groups in this outcome

CNS Patients - Treatment (Combination Chemotherapy)

All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.

Testicular Relapse Patients (Combination Chemotherapy)

All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.

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
CNS Patients - Treatment (Combination Chemotherapy)	120
Testicular Relapse Patients (Combination Chemotherapy)	40

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CNS Patients - Treatment (Combination Chemotherapy)	64.9	Not reported	Not reported	Not reported	Not reported
Testicular Relapse Patients (Combination Chemotherapy)	70	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
64.9
group Id
OG001
value
70

denoms

counts
group Id
OG000
value
120
group Id
OG001
value
40
units
Participants

description

Monitoring of efficacy results will be performed in comparison with historical results.

groups

description
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
id
OG000
title
CNS Patients - Treatment (Combination Chemotherapy)
description
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
id
OG001
title
Testicular Relapse Patients (Combination Chemotherapy)

param Type

NUMBER

population Description

The CNS-treatment cohort includes 126 patients with 120 CNS pre-B, 2 CNS+ITR pre-B and 4 T-AL. The primary analysis was restricted to CNS pre-B and ITR pre-B patients, respectively. Both CNS+ITR and T-ALL patients had to be excluded from the primary analysis. That is how we came to 120 in the CNS-treatment cohort for outcome analysis.

reporting Status

POSTED

time Frame

3 years

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