Brief Summary

The main purpose of this study is to find out how well participants with relapsed or refractory ALL respond to treatment with an etoposide- and teniposide-based induction chemotherapy regimen and what the side effects are. Primary Objectives:

To estimate the response rate for patients with refractory or relapsed ALL.
To estimate the survival rate of patients with refractory or relapsed ALL treated with risk-directed therapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Nov 2003

Longer than P75 for phase_2

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.8 years study duration

Study Start

First participant enrolled

November 1, 2003

Completed

1.8 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed

15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed

8.3 years until next milestone

Results Posted

Study results publicly available

December 16, 2013

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed

Last Updated

July 28, 2017

Status Verified

June 1, 2017

Enrollment Period

12.8 years

First QC Date

September 1, 2005

Results QC Date

October 25, 2013

Last Update Submit

July 26, 2017

Conditions

Acute Lymphoblastic Leukemia Lymphoma, Lymphoblastic

Keywords

LeukemiaLymphoblasticAcuteLymphomaNon-Hodgkin's

Outcome Measures

Primary Outcomes (2)

Response Rate
The "response rate" is defined as the proportion of participants who attain morphological complete remission after the re-induction Block C, inclusive of all patients who begin re-induction. Morphological complete remission was defined as \<5% blasts in bone marrow by morphology.
End of re-induction Block C (approximately 1 month after the start of therapy)
Overall Survival (OS)
OS is measured from the start of on-study to the date of death or to the last date of follow-up. Measurement is determined by Kaplan-Meyer estimate. The probability of survival at 5 years after diagnosis is given.
2 years after last patient completes therapy (approximately 4 years after enrollment)

Other Outcomes (2)

Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)
End of Block Block C therapy (Day 46)
Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)
End of Block B therapy (Day 19)

Study Arms (1)

Treatment

OTHER

Participants receive chemotherapy, intrathecal chemotherapy, steroid therapy, hematopoietic stem cell transplant, and natural killer cell transplant as outlined in the Interventions section, including etoposide, cytarabine, vincristine, dexamethasone, methotrexate, teniposide, PEG-asparaginase, mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine, L-asparaginase, erwinia asparaginase.

Drug: Etoposide, cytarabine, vincristine, dexamethasoneDrug: methotrexate, teniposide, PEG-asparaginaseDrug: mitoxantrone, cyclophosphamide, mercaptopurine, vinblastineDrug: L-asparaginase, erwinia asparaginaseProcedure: chemotherapy, intrathecal chemotherapy, steroid therapyProcedure: Hematopoietic Stem Cell TransplantProcedure: Natural Killer (NK) Cell Transplant