Trial · NCT00981799
Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL
NCT00981799, Phase 1, Phase 2, Terminated, Therapeutic Advances in Childhood Leukemia Consortium; results first posted 2020-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL. Trials, record NCT00981799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00981799
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL
- NCT number
- NCT00981799
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
- Conditions
- Relapsed T-Cell Acute Lymphoblastic Leukemia, Relapsed T-Cell Lymphoblastic Lymphoma
- Interventions
- Nelarabine, Etoposide, Cyclophosphamide, Methotrexate, Filgrastim
- First posted
- 2009-09-22
- Last updated
- 2020-10-01
- Results first posted
- 2020-10-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. | 6 months | Patients will be evaluated based on Dose Level and total courses taken at each dose level and for presence of dose limiting toxicities. Not all patients enrolled at each dose level has been assessed to be evaluable for DLTs. Only those that have met criteria for being evaluable for DLT will be counted in the Overall Number of Participants Analyzed. |
| Secondary | To Determine the Complete Remission Rate After 1 and 2 Courses of This Therapy in Children With T-ALL and Bone Marrow Relapse or T-LL. | 1-3 months | Patients will be evaluated at each dose level and for assessment of response to treatment. Not all patients enrolled at each dose level has been assessed to be evaluable for response. Only those that have met criteria for being evaluable for response will be counted in the Overall Number of Participants Analyzed. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. | 6 months | There are 0 patients for Dose Level 0 as no patients met the criteria to be enrolled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Determine the Complete Remission Rate After 1 and 2 Courses of This Therapy in Children With T-ALL and Bone Marrow Relapse or T-LL. | 1-3 months | No patients met the criteria to be enrolled at Dose Level 0. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. | Nelarabine Dose Level 1 | # of patients with DLT | 0 | Participants | |
| To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. | Nelarabine Dose Level 2 | # of patients with DLT | 1 | Participants | |
| To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. | Nelarabine Dose Level 3 | # of patients with DLT | 2 | Participants | |
| To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. | Nelarabine Dose Level 0 | # of patients with DLT | 0 | Participants | |
| To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. | Nelarabine Dose Level 1 | # of patients without DLT | 5 | Participants | |
| To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. | Nelarabine Dose Level 2 | # of patients without DLT | 5 | Participants | |
| To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. | Nelarabine Dose Level 3 | # of patients without DLT | 8 | Participants | |
| To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. | Nelarabine Dose Level 0 | # of patients without DLT | 0 | Participants | |
| To Determine the Complete Remission Rate After 1 and 2 Courses of This Therapy in Children With T-ALL and Bone Marrow Relapse or T-LL. | Nelarabine Dose Level 1 | # of patients not with complete remission | 3 | Participants | |
| To Determine the Complete Remission Rate After 1 and 2 Courses of This Therapy in Children With T-ALL and Bone Marrow Relapse or T-LL. | Nelarabine Dose Level 2 | # of patients not with complete remission | 4 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nelarabine Dose Level 1 | 6 | |
| Overall Study | STARTED | Nelarabine Dose Level 2 | 7 | |
| Overall Study | STARTED | Nelarabine Dose Level 3 | 10 | |
| Overall Study | STARTED | Nelarabine Dose Level 0 | 0 | |
| Overall Study | COMPLETED | Nelarabine Dose Level 1 | 5 | |
| Overall Study | COMPLETED | Nelarabine Dose Level 2 | 6 | |
| Overall Study | COMPLETED | Nelarabine Dose Level 3 | 10 | |
| Overall Study | COMPLETED | Nelarabine Dose Level 0 | 0 | |
| Overall Study | NOT COMPLETED | Nelarabine Dose Level 1 | 1 | |
| Overall Study | NOT COMPLETED | Nelarabine Dose Level 2 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events292
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 | Alanine aminotransferase increased | Investigations | Nelarabine Dose Level 1 | 1 | 6 | 1 |
| other | Alanine aminotransferase increased | Investigations | Nelarabine Dose Level 2 | 0 | 7 | 0 |
| other | Alanine aminotransferase increased | Investigations | Nelarabine Dose Level 3 | 2 | 10 | 4 |
| other | Alanine aminotransferase increased | Investigations | Nelarabine Dose Level 0 | 0 | ||
| other | Back pain | Musculoskeletal and connective tissue disorders | Nelarabine Dose Level 1 | 1 | 6 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Nelarabine Dose Level 2 | 0 | 7 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Nelarabine Dose Level 3 | 0 | 10 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Nelarabine Dose Level 0 | 0 | ||
| other | Epistaxis | Ear and labyrinth disorders | Nelarabine Dose Level 1 | 1 | 6 | 1 |
| other | Epistaxis | Ear and labyrinth disorders | Nelarabine Dose Level 2 | 0 | 7 | 0 |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nelarabine Dose Level 1 | 4 | 6 |
| Total, all-cause mortality | Nelarabine Dose Level 2 | 7 | 7 |
| Total, all-cause mortality | Nelarabine Dose Level 3 | 8 | 10 |
| Total, all-cause mortality | Nelarabine Dose Level 0 | 0 | 0 |
| Total, other adverse events | Nelarabine Dose Level 1 | 6 | 6 |
| Total, other adverse events | Nelarabine Dose Level 2 | 7 | 7 |
| Total, other adverse events | Nelarabine Dose Level 3 | 10 | 10 |
| Total, other adverse events | Nelarabine Dose Level 0 | 0 | 0 |
| Total, serious adverse events | Nelarabine Dose Level 1 | 1 | 6 |
| Total, serious adverse events | Nelarabine Dose Level 2 | 5 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT00981799
GET https://conductscience.org/api/trials/v1/NCT00981799/events?page=2