Trial · NCT02518750
Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma
NCT02518750, Phase 2, Terminated, St. Jude Children's Research Hospital; results first posted 2019-04-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma. Trials, record NCT02518750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02518750
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma
- NCT number
- NCT02518750
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Acute Lymphoblastic Leukemia, Lymphoma, Non-Hodgkin's, Leukemia, T-Cell, Leukemia, B-Cell
- Interventions
Dexamethasone, Panobinostat, Liposomal vincristine, Mitoxantrone, Peg-asparaginase, Bortezomib, Intrathecal Triples, High-dose methotrexate, 6-Mercaptopurine, High-dose cytarabine, Nelarabine, Cyclophosphamide, Etoposide, Clofarabine
- First posted
- 2015-08-10
- Last updated
- 2019-04-03
- Results first posted
- 2019-04-03
- Limitations and caveats
- Given the very small enrollment number, no statistical analyses was performed.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Remission (CR) Rate | At the end of each remission re-induction block C (approximately 13 weeks after start of therapy) | All participants who start re-induction Block A therapy are considered evaluable. Any patient who at any time point achieves CR and goes to transplant is considered as a success; or any patient who successfully reaches the end of block C and achieves/remains in CR is considered a success; all other cases are considered as failure. |
| Secondary | Block A Minimal Residual Disease (MRD) | At the end of Block A therapy (approximately 5 weeks after start of therapy) | MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates. |
| Secondary | Block B Minimal Residual Disease (MRD) | At the end of Block B therapy (approximately 10 weeks after start of therapy) | MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates. |
| Secondary | Block C Minimal Residual Disease (MRD) | At the end of Block C therapy (approximately 13 weeks after start of therapy) | MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates. |
| Secondary | Proportion of Relevant Toxicities | At the completion of therapy (up to approximately 5 months after the start of therapy) | The toxicities of liposomal vincristine (VSLI) when used in combination with chemotherapy will be evaluated. Proportions (probabilities) of relevant toxicities will be estimated with point and interval estimates. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Remission (CR) Rate | At the end of each remission re-induction block C (approximately 13 weeks after start of therapy) | Given the very small enrollment number, no statistical analyses was performed. | ||
| SECONDARY | Block A Minimal Residual Disease (MRD) | At the end of Block A therapy (approximately 5 weeks after start of therapy) | Given the very small enrollment number, no statistical analyses was performed. | ||
| SECONDARY | Block B Minimal Residual Disease (MRD) | At the end of Block B therapy (approximately 10 weeks after start of therapy) | No participant received Block B therapy. | ||
| SECONDARY | Block C Minimal Residual Disease (MRD) | At the end of Block C therapy (approximately 13 weeks after start of therapy) | No participant received Block C therapy. | ||
| SECONDARY | Proportion of Relevant Toxicities | At the completion of therapy (up to approximately 5 months after the start of therapy) | Given the very small enrollment number, no statistical analyses was performed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study Paticipants | 3 | |
| Overall Study | COMPLETED | Study Paticipants | 1 | |
| Overall Study | NOT COMPLETED | Study Paticipants | 2 |
Source ClinicalTrials.gov
Adverse events19
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypokalemia | Metabolism and nutrition disorders | Study Participants | 2 | 3 | 9 |
| other | Hypernatremia | Metabolism and nutrition disorders | Study Participants | 1 | 3 | 5 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Study Participants | 2 | 3 | 4 |
| other | Hypocalcemia | Metabolism and nutrition disorders | Study Participants | 2 | 3 | 3 |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Study Participants | 1 | 3 | 3 |
| other | Headache | Nervous system disorders | Study Participants | 1 | 3 | 3 |
| other | Sepsis | Infections and infestations | Study Participants | 2 | 3 | 2 |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Study Participants | 1 | 3 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Study Participants | 1 | 3 | 1 |
| other | Nausea | Gastrointestinal disorders | Study Participants | 1 | 3 | 1 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study Participants | 3 | 3 |
| Total, other adverse events | Study Participants | 2 | 3 |
| Total, serious adverse events | Study Participants | 2 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02518750
GET https://conductscience.org/api/trials/v1/NCT02518750/registered