Acute Lymphoblastic Leukemia treatment protocol for children and adolescent

Acute Lymphoblastic Leukemia treatment protocol for children and adolescent GBTLI ALL-2009 - GBTLI ALL-2009: GBTLI ALL-2009

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-6pmfz8

Enrollment

Unknown

Registered

2016-03-11

Start date

2010-01-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia of children and adolescent patients

Interventions

After Phase Delayed Consolidation , random draw will be held for two groups of Maintenance Therapy: Intermittent maintenance therapy with 6 -MP (100 mg / m2 / day x 10 , with 11 days rest) associated

Drug

D03.438.733.631.192.500

Eligibility

Age

0 Days to 18 Years

Inclusion criteria

Inclusion criteria: Will be eligible for this study all patients aged < 18 years (up to 17.99 years ) diagnosed with previously untreated ALL, with emphasis on no steroid use. The requisites for proper leukemia diagnostic profile are: cytomorphological analysis, cytochemistry, immunephenotyping spinal fluid profile, cytogenetics and molecular biology All patients and their legal representatives should be informed about the investigative nature of this study and must sign and provide free and informed consent in accordance with institutional and federal recommendations.

Exclusion criteria

Exclusion criteria: Without Informed Consent Term. ALL patient aged > 18 years. Prior use of corticosteroids. Not confirmed the ALL diagnosis, after Central review.

Design outcomes

Primary

Measure	Time frame
Expected outcome: the leukemia-free survival in the group of children with escalated dose of methotrexate during the maintenance phase will be higher than that for the group of children with the fixed dose of methotrexate. The two groups will be randomized prior to the start of the maintenance phase. The leukemia-free survival curves will be estimated by the Kaplan-Meier method, with standard deviation proposed by Greenwood, and compared using the log-rank test. The starting point of observation will be the date of the bone marrow examination in which the morphologic remission of leukemia was observed, ie, percentage of blasts less than 5%. The final observation points will be the recurrence of leukemia in any organ, death in continuous remission, second malignancy or last child consultation date, this being in continuous remission. The Cox regression model will be used for regression equation adjustment to other prognostic factors. It is expected that, by comparing the two groups, there will be a difference in the leukemia-free survival curves between 5% and 10%.	—

Measure

Time frame

Expected outcome: the leukemia-free survival in the group of children with escalated dose of methotrexate during the maintenance phase will be higher than that for the group of children with the fixed dose of methotrexate. The two groups will be randomized prior to the start of the maintenance phase. The leukemia-free survival curves will be estimated by the Kaplan-Meier method, with standard deviation proposed by Greenwood, and compared using the log-rank test. The starting point of observation will be the date of the bone marrow examination in which the morphologic remission of leukemia was observed, ie, percentage of blasts less than 5%. The final observation points will be the recurrence of leukemia in any organ, death in continuous remission, second malignancy or last child consultation date, this being in continuous remission. The Cox regression model will be used for regression equation adjustment to other prognostic factors. It is expected that, by comparing the two groups, there will be a difference in the leukemia-free survival curves between 5% and 10%.

—

Secondary

Measure	Time frame
Expected outcome: the cumulative incidence of leukemic relapse for the group of children with the escalated dose of methotrexate during the maintenance phase will be inferior than that for the group with fixed dose of methotrexate. The curves of cumulative incidence of leukemic relapse will be estimated with adjustments for competing risks of other events, such as death in remission or second malignancy and will be compared by the Gray's test. The starting point of observation will be the date of the bone marrow examination in which the morphologic remission of leukemia was observed, ie, percentage of blasts less than 5%. The end point of observation will be leukemic relapse in any organ or the last child consultation date, this being in continuous remission. Death in continuous remission or diagnosis of a second malignancy will be considered competing events. The Fine-Gray regression model will be used for regression equation adjustment to other prognostic factors. It is expected that, by comparing the two groups, there will be a difference in the cumulative incidence curves of leukemic relapse between 5% and 10%.	—

Measure

Time frame

Expected outcome: the cumulative incidence of leukemic relapse for the group of children with the escalated dose of methotrexate during the maintenance phase will be inferior than that for the group with fixed dose of methotrexate. The curves of cumulative incidence of leukemic relapse will be estimated with adjustments for competing risks of other events, such as death in remission or second malignancy and will be compared by the Gray's test. The starting point of observation will be the date of the bone marrow examination in which the morphologic remission of leukemia was observed, ie, percentage of blasts less than 5%. The end point of observation will be leukemic relapse in any organ or the last child consultation date, this being in continuous remission. Death in continuous remission or diagnosis of a second malignancy will be considered competing events. The Fine-Gray regression model will be used for regression equation adjustment to other prognostic factors. It is expected that, by comparing the two groups, there will be a difference in the cumulative incidence curves of leukemic relapse between 5% and 10%.

—

Countries

Brazil

Contacts

Public ContactSilvia Brandalise

Centro Infantil Boldrini

silvia@boldrini.org.br+55(19) 3787-5000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)