Trial · NCT03117751
Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma
NCT03117751, Phase 2, Phase 3, Active not recruiting, St. Jude Children's Research Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma. Trials, record NCT03117751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03117751
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma
- NCT number
- NCT03117751
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 790 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Acute Lymphoblastic Leukemia, Acute Lymphoblastic Lymphoma
- Interventions
Prednisone, Vincristine, Daunorubicin, Pegaspargase, Erwinase®, Cyclophosphamide, Cytarabine, Mercaptopurine, Dasatinib, Methotrexate, Blinatumomab, Ruxolitinib, Bortezomib, Dexamethasone, Doxorubicin, Etoposide, Clofarabine, Vorinostat, Idarubicin, Nelarabine, Thioguanine, Asparaginase Erwinia chrysanthemi (recombinant)-rywn, Calaspargase Pegol
- First posted
- 2017-04-18
- Last updated
- 2026-06-17
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free survival of ALL patients (EFS) | At 3.5 years after enrollment of the last participant | 5-year EFS: Kaplan-Meier estimates of EFS curve of ALL patients will be computed and compared historically with those of the St. Jude Children's Research Hospital's (SJCRH) TOTXVI study (NCT00549848). All eligible patients entered on the current TOT17 study will be included in these comparisons. Comparisons by log-rank tests will be made both un-stratified and stratified by risk groups. |
| Primary | Proportion of patients with CEP72TT genotype who develop two or more episodes of Grade 2 or higher neuropathy during Continuation | At 6 months after the last randomized patient completes Continuation Treatment (Week 120). | This will be a single-blind, stratified block randomized experiment. Although the investigators who evaluate neuropathy and neuropathic pain and the patients are blinded for treatment assignment, treating clinicians and pharmacy staff are not. Patients will be randomized at a 1:1 ratio into two treatment groups: 1.5 mg/m\^2 vs. 1 mg/m\^2 vincristine (VCR) dose. Randomization will be stratified by two factors known to significantly affect neuropathy during the Continuation phase, namely, Grade 2 or higher neuropathy prior to Continuation (none, 1 episode, 2 or more episodes) and race (black, others). The proportion of patients who develop two or more episodes of Grade 2 or higher neuropathy during Continuation Treatment will be compared between the two VCR dose groups, using a Z-test for two sample proportions. |
| Primary | Cumulative incidence of Grade 2 or higher neuropathy in patients with CEP72 CC or CT genotype | After the last randomized patient is followed for 1 year after Week 101 of Continuation therapy | This will be a single blind stratified block randomized experiment. The investigators who evaluate neuropathy and neuropathic pain and the patients are blinded for treatment assignment. Treating clinicians and pharmacy staff will not be blinded. Standard/high-risk patients will be randomized at a 1:1 ratio into two treatment groups at Week 49 of Continuation therapy: to vincristine + dexamethasone (VCR+DEX) pulses or to 6-mercaptopurine + methotrexate (6MP+MTX). The primary analysis will compare the cumulative incidence of the first episode of Grade 2 or higher neuropathy or neuropathic pain (the end point) by stratified Gray's test. Adverse events other than the endpoint rendering a patient drop out after Continuation Week 49 are regarded as competing events. |
| Secondary | 5-year overall survival (OS) of ALL patients compared to historical controls | 3.5 years after enrollment of the last patient | Kaplan-Meier estimates of OS curve of ALL patients will be computed and compared historically with those of the St. Jude Children's Research Hospital's (SJCRH) TOTXVI study (NCT00549848). All eligible patients entered on the current TOT17 study will be included in these comparisons. Comparisons by log-rank tests will be made both un-stratified and stratified by risk groups. |
| Secondary | EFS of LLy patients | 3.5 years after enrollment of the last patient | 5-year EFS: Kaplan-Meier estimates of EFS curve in patients with LLy will be computed. |
| Secondary | 5-year OS of LLy patients | 3.5 years after enrollment of the last patient | Kaplan-Meier estimates of OS curve in patients with LLy will be computed. |
| Secondary | The efficacy of blinatumomab in B-ALL patients | 3.5 years after enrollment of the last patient | Comparison with historical control by log-rank tests will be performed. |
| Secondary | Comparison of MRD measurements between flow cytometry and sequencing | From Day 8 through Day 42 after remission induction (At 6 months after enrollment of the 40^t^h evaluable patient) | For this comparison, 40 patients will be accrued for Day 8, Day 15 and Day 42 MRD, and primarily assess the correlation and concordance between the two methods at these time points if sufficient cells are available, and secondarily analyze for Day 22 and MRD levels obtained after remission induction. |
| Secondary | Log hazard ratio of the association of low level of MRD and treatment outcome | 3.5 years after enrollment of the last patient | The investigators will analyze the association of next-generation sequencing-determined MRD level (as a continuous variable) with the risk of relapses in bone marrow and possibly other sites (bone marrow or combined relapses). Fine-Gray regression model will be applied to estimate the hazard ratio of relapse as a function of the increase in MRD level. |
| Secondary | Comparison of bone marrow and peripheral blood MRD | From Day 15 through Day 42 of remission induction and end of therapy (At 6 months after enrollment of the last evaluable patient) | Parametric (linear) or non-parametric (if necessary) regression models will be fitted to analyze the relationship between the MRD levels in peripheral blood by sequencing methods and MRD levels in bone marrow (by sequencing or flow cytometry). The peripheral blood MRD level corresponding to 0.01% in bone marrow is then obtained by solving the (regression) equation for the peripheral blood MRD level. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42154791 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03117751
GET https://conductscience.org/api/trials/v1/NCT03117751/registered?page=2