Trial · NCT02112916
Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
NCT02112916, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2022-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma. Trials, record NCT02112916. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02112916
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
- NCT number
- NCT02112916
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 847 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adult T Acute Lymphoblastic Leukemia, Ann Arbor Stage II Adult Lymphoblastic Lymphoma, Ann Arbor Stage II Childhood Lymphoblastic Lymphoma, Ann Arbor Stage III Adult Lymphoblastic Lymphoma, Ann Arbor Stage III Childhood Lymphoblastic Lymphoma, Ann Arbor Stage IV Adult Lymphoblastic Lymphoma, Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma, Childhood T Acute Lymphoblastic Leukemia
- Interventions
Bortezomib, Cyclophosphamide, Cytarabine, Daunorubicin, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin, Doxorubicin Hydrochloride, Etoposide, Hydrocortisone Sodium Succinate, Ifosfamide, Leucovorin Calcium, Mercaptopurine, Methotrexate, Pegaspargase, Radiation Therapy, Thioguanine, Vincristine, Vincristine Sulfate
- First posted
- 2014-04-14
- Last updated
- 2026-10-21
- Results first posted
- 2022-02-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients | 3 years | EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups. |
| Secondary | Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase | 3 years from start of therapy by patient | Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
| Secondary | EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT) | 3 years | EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. |
| Secondary | Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) | 3 years | Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988 |
| Secondary | EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3 | 3 years | EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact. |
| Secondary | EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond | 3 years | EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients | 3 years | As pre-specified in the protocol, this analysis includes all eligible patients (T-ALL+T-LLy) enrolled on the study. Arms were combined for this analysis as pre-specified in the protocol. | Percentage of participants | NUMBER |
| SECONDARY | Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase | 3 years from start of therapy by patient | As pre-specified in the protocol, this analysis includes all eligible patients (T-ALL+T-LLy) enrolled on the study. | Percentage of participants | NUMBER |
| SECONDARY | EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT) | 3 years | T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 \[NCT00408005\] Low Risk definition). T-ALL on AALL0434 \[NCT00408005\] (who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1% | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) | 3 years | T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 \[NCT00408005\] Low Risk definition). T-ALL on AALL0434 \[NCT00408005\](who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1% | Percentage of participants | NUMBER |
| SECONDARY | EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3 | 3 years | VHR T-ALL patients who had EOC MRD \>= 0.1%, completed the three high-risk blocks of therapy, and had MRD assessment done after the three high-risk blocks. MRD was not performed in T-LLy patients at end of the VHR blocks. MRD is not used in T-LLy to measure disease response. This outcome measure was pre-specified to only be assessed in the T-ALL patients. | Percentage of participants | NUMBER |
| SECONDARY | EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond | 3 years | VHR T-LL patients who completed the three high-risk blocks of therapy. The T-LLy VHR patients are included in the table, but there were not enough patients to do any formal analysis, eg there was only one patient (n=1) on the study with T-LLy who had radiographic disease assessment after the intensification blocks. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients | Arm A (Combination Chemotherapy) | 81.7 | 95% Confidence Interval 77.0 to 86.4 | Percentage of participants | |
| Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients | Arm B (Combination Chemotherapy, Bortezomib) | 85.1 | 95% Confidence Interval 80.8 to 89.4 | Percentage of participants | |
| Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase | Total Patients | 78.0 | 95% Confidence Interval 75.2 to 80.9 | Percentage of participants | |
| EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT) | AALL1231 T-ALL Patients | 88.3 | 95% Confidence Interval 83.2 to 93.4 | Percentage of participants | |
| EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT) | AALL0434 T-ALL Patients | 88.8 | 95% Confidence Interval 86.3 to 91.4 | Percentage of participants | |
Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) | AALL1231 T-ALL Patients | Isolated CNS Relapse | 3.6 | 95% Confidence Interval 1.1 to 6.1 | Percentage of participants |
Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) | AALL0434 T-ALL Patients | Isolated CNS Relapse | 2.2 | 95% Confidence Interval 1.0 to 3.4 | Percentage of participants |
Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) | AALL1231 T-ALL Patients | Isolated Bone Marrow Relapse | 1.4 | 95% Confidence Interval 0 to 3.0 | Percentage of participants |
Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) | AALL0434 T-ALL Patients | Isolated Bone Marrow Relapse | 3.0 | 95% Confidence Interval 1.6 to 4.4 | Percentage of participants |
Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) | AALL1231 T-ALL Patients | Combined Bone Marrow Relapse | 1.3 | 95% Confidence Interval 0 to 2.9 | Percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Combination Chemotherapy): T-ALL | 312 | |
| Overall Study | STARTED | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | 315 | |
| Overall Study | STARTED | Arm A (Combination Chemotherapy): T-LLy | 111 | |
| Overall Study | STARTED | Arm B (Combination Chemotherapy, Bortezomib): T-LLy | 109 | |
| Overall Study | COMPLETED | Arm A (Combination Chemotherapy): T-ALL | 108 | |
| Overall Study | COMPLETED | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | 123 | |
| Overall Study | COMPLETED | Arm A (Combination Chemotherapy): T-LLy | 52 | |
| Overall Study | COMPLETED | Arm B (Combination Chemotherapy, Bortezomib): T-LLy | 62 | |
| Overall Study | NOT COMPLETED | Arm A (Combination Chemotherapy): T-ALL | 204 | |
| Overall Study | NOT COMPLETED | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | 192 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,508
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 | Anemia | Blood and lymphatic system disorders | Arm A (Combination Chemotherapy): T-ALL | 3 | 308 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | 3 | 307 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Arm A (Combination Chemotherapy): T-LLy | 1 | 108 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Combination Chemotherapy, Bortezomib): T-LLy | 1 | 101 | 1 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm A (Combination Chemotherapy): T-ALL | 2 | 308 | 2 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | 0 | 307 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm A (Combination Chemotherapy): T-LLy | 0 | 108 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm B (Combination Chemotherapy, Bortezomib): T-LLy | 0 | 101 | 0 |
| other | Bone marrow hypocellular | Blood and lymphatic system disorders | Arm A (Combination Chemotherapy): T-ALL | 1 | 308 | 1 |
| other | Bone marrow hypocellular | Blood and lymphatic system disorders | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | 0 | 307 | 0 |
1 to 10 of 1,508Source ClinicalTrials.gov
See all 1,508 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Combination Chemotherapy): T-ALL | 38 | 308 |
| Total, all-cause mortality | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | 38 | 307 |
| Total, all-cause mortality | Arm A (Combination Chemotherapy): T-LLy | 23 | 108 |
| Total, all-cause mortality | Arm B (Combination Chemotherapy, Bortezomib): T-LLy | 9 | 101 |
| Total, other adverse events | Arm A (Combination Chemotherapy): T-ALL | 231 | 308 |
| Total, other adverse events | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | 217 | 307 |
| Total, other adverse events | Arm A (Combination Chemotherapy): T-LLy | 86 | 108 |
| Total, other adverse events | Arm B (Combination Chemotherapy, Bortezomib): T-LLy | 74 | 101 |
| Total, serious adverse events | Arm A (Combination Chemotherapy): T-ALL | 56 | 308 |
| Total, serious adverse events | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | 153 | 307 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 | NIH RePORTER |
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/NCT02112916
GET https://conductscience.org/api/trials/v1/NCT02112916/events?page=2