Trial · NCT01979536
Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma
NCT01979536, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-07-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma. Trials, record NCT01979536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01979536
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma
- NCT number
- NCT01979536
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 137 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Anaplastic Large Cell Lymphoma, ALK-Positive, Ann Arbor Stage II Noncutaneous Childhood Anaplastic Large Cell Lymphoma, Ann Arbor Stage III Noncutaneous Childhood Anaplastic Large Cell Lymphoma, Ann Arbor Stage IV Noncutaneous Childhood Anaplastic Large Cell Lymphoma
- Interventions
- Brentuximab Vedotin, Crizotinib, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin Hydrochloride, Etoposide, Ifosfamide, Methotrexate
- First posted
- 2013-11-08
- Last updated
- 2024-04-30
- Results first posted
- 2022-07-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of Grade 3+ Non-hematologic Adverse Events | Up to 60 months | Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be summarized by individual toxicity counts separated by arm. |
| Primary | Event Free Survival (EFS) | Time from study entry until progressive disease, relapse, or death, assessed up to 2 years | The Kaplan-Meier method will be used to estimate the 2-year EFS for each of the treatment regimens. |
| Secondary | Prognostic Significance of Minimal Residual Disease | Baseline up to progressive disease, relapse, or death, assessed up to 2 years | Analyzed by estimating the 2-year EFS of negative MRD and positive MRD by arm. Minimal disease was performed using serial assessments of the t(2;5)(p23;q35) NPM-ALK fusion transcript using quantitative RT-PCR. Quantitative RT-PCR was performed by extracting total RNA from peripheral blood specimens. Peripheral blood samples were obtained at baseline, on day 1 of cycle 1, and on day 1 of cycle 2. The normalized copy numbers (NCN) were expressed as copy numbers of NPM-ALK per 104 copies of ABL. Minimal disease (MDD) was defined as \>10 NCN at baseline. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence of Grade 3+ Non-hematologic Adverse Events | Up to 60 months | 1 Arm BV patient who did not receive at least one dose of brentuximab vedotin and 3 Arm CZ patients who did not receive at least one dose of crizotinib are excluded from these analyses. | Percentage of patients | NUMBER |
| PRIMARY | Event Free Survival (EFS) | Time from study entry until progressive disease, relapse, or death, assessed up to 2 years | 1 Arm CZ patient who did not start treatment is excluded from analyses of EFS. | Percentage of patients | NUMBER |
| SECONDARY | Prognostic Significance of Minimal Residual Disease | Baseline up to progressive disease, relapse, or death, assessed up to 2 years | 11 Arm BV patients without adequate MDD baseline data, 1 Arm CZ patient who did not start treatment, and 11 Arm CZ patients without adequate MDD baseline data are excluded from these analyses. | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of Grade 3+ Non-hematologic Adverse Events | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 80.6 | 95% Confidence Interval 69.1 to 89.2 | Percentage of patients | |
| Occurrence of Grade 3+ Non-hematologic Adverse Events | Arm CZ (Crizotinib, Combination Chemotherapy) | 87.9 | 95% Confidence Interval 77.5 to 94.6 | Percentage of patients | |
| Event Free Survival (EFS) | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 78.8 | 95% Confidence Interval 67.2 to 87.1 | Percentage of patients | |
| Event Free Survival (EFS) | Arm CZ (Crizotinib, Combination Chemotherapy) | 76.8 | 95% Confidence Interval 68.5 to 88.1 | Percentage of patients | |
| Prognostic Significance of Minimal Residual Disease | MRD Negative Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 89 | 95% Confidence Interval 73.1 to 95.7 | Percentage of patients | |
| Prognostic Significance of Minimal Residual Disease | MRD Positive Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 52.6 | 95% Confidence Interval 28.7 to 71.9 | Percentage of patients | |
| Prognostic Significance of Minimal Residual Disease | MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy) | 85.6 | 95% Confidence Interval 68.6 to 93.8 | Percentage of patients | |
| Prognostic Significance of Minimal Residual Disease | MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy) | 58.1 | 95% Confidence Interval 33.4 to 76.4 | Percentage of patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 68 | |
| Overall Study | STARTED | Arm CZ (Crizotinib, Combination Chemotherapy) | 69 | |
| Overall Study | COMPLETED | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 66 | |
| Overall Study | COMPLETED | Arm CZ (Crizotinib, Combination Chemotherapy) | 61 | |
| Overall Study | NOT COMPLETED | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 2 | |
| Overall Study | NOT COMPLETED | Arm CZ (Crizotinib, Combination Chemotherapy) | 8 |
Source ClinicalTrials.gov
Adverse events282
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 BV (Brentuximab Vedotin, Combination Chemotherapy) | 22 | 68 | |
| other | Anemia | Blood and lymphatic system disorders | Arm CZ (Crizotinib, Combination Chemotherapy) | 27 | 68 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 0 | 68 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm CZ (Crizotinib, Combination Chemotherapy) | 1 | 68 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 30 | 68 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm CZ (Crizotinib, Combination Chemotherapy) | 30 | 68 | |
| other | Periorbital edema | Eye disorders | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 0 | 68 | |
| other | Periorbital edema | Eye disorders | Arm CZ (Crizotinib, Combination Chemotherapy) | 1 | 68 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 0 | 68 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm CZ (Crizotinib, Combination Chemotherapy) | 2 | 68 |
1 to 10 of 282Source ClinicalTrials.gov
See all 282 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 3 | 68 |
| Total, all-cause mortality | Arm CZ (Crizotinib, Combination Chemotherapy) | 3 | 68 |
| Total, other adverse events | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 57 | 68 |
| Total, other adverse events | Arm CZ (Crizotinib, Combination Chemotherapy) | 55 | 68 |
| Total, serious adverse events | Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 24 | 68 |
| Total, serious adverse events | Arm CZ (Crizotinib, Combination Chemotherapy) | 41 | 68 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm BV (Brentuximab Vedotin, Combination Chemotherapy) vs Arm CZ (Crizotinib, Combination Chemotherapy): deaths from any cause | Trial comparisons |
| Arm BV (Brentuximab Vedotin, Combination Chemotherapy) vs Arm CZ (Crizotinib, Combination Chemotherapy): serious adverse events | Trial comparisons |
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/NCT01979536
GET https://conductscience.org/api/trials/v1/NCT01979536/events?page=2