Trial · NCT00669877
Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma
NCT00669877, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2018-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma. Trials, record NCT00669877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00669877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma
- NCT number
- NCT00669877
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Burkitt's Lymphoma, Burkitt'S-like Lymphoma
- Interventions
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone, G-CSF, Cytarabine, Methotrexate
- First posted
- 2008-05-01
- Last updated
- 2018-05-16
- Results first posted
- 2018-05-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Remission Rate: Percentage of Participants With Complete Remission (CR) | After two 21-day courses, response to treatment checked for Complete Remission (CR) | Complete Remission (CR) was defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count ≥1.0 × 10\^9/L, a platelet count ≥100 × 10\^9/L, and no extramedullary disease. Complete recovery except platelets (CRp) was defined as for CR, except for recovery of platelet count to \<100 × 10\^9/L. Partial remission (PR) was defined as a bone marrow with \>5% and \<25% blasts with a granulocyte count of ≥1.0 × 109/L and a platelet count of ≥100 × 10\^9/L. Relapse was defined by recurrence of more than 5% lymphoblasts in the bone marrow aspirate or by the presence of extramedullary disease after achieving CR. |
| Other | Overall Response Rate: Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) | After two 21-day courses, response to treatment checked for Complete Remission (CR) | Complete Remission (CR) was defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count ≥1.0 × 10\^9/L, a platelet count ≥100 × 10\^9/L, and no extramedullary disease. Complete recovery except platelets (CRp) was defined as for CR, except for recovery of platelet count to \<100 × 10\^9/L. Partial remission (PR) was defined as a bone marrow with \>5% and \<25% blasts with a granulocyte count of ≥1.0 × 109/L and a platelet count of ≥100 × 10\^9/L. Relapse was defined by recurrence of more than 5% lymphoblasts in the bone marrow aspirate or by the presence of extramedullary disease after achieving CR. |
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 | Complete Remission Rate: Percentage of Participants With Complete Remission (CR) | After two 21-day courses, response to treatment checked for Complete Remission (CR) | Of fifty-six registered, nine participants entered the study with CR therefore were not evaluable for response. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Overall Response Rate: Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) | After two 21-day courses, response to treatment checked for Complete Remission (CR) | Of fifty-six registered, nine participants entered the study with CR therefore were not evaluable for response. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Remission Rate: Percentage of Participants With Complete Remission (CR) | Hyper-CVAD | 85 | percentage of participants | ||
| Overall Response Rate: Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) | Hyper-CVAD | 89 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hyper-CVAD | 56 | |
| Overall Study | COMPLETED | Hyper-CVAD | 52 | |
| Overall Study | NOT COMPLETED | Hyper-CVAD | 4 |
Source ClinicalTrials.gov
Adverse events45
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 | Bacterial Infection | Infections and infestations | Hyper-CVAD | 16 | 56 | |
| other | Fever, Unknown Origin | General disorders | Hyper-CVAD | 24 | 56 | |
| other | Pneumonia, Unknown Pathogen | Infections and infestations | Hyper-CVAD | 16 | 56 | |
| other | Bacterial Pneumonia | Infections and infestations | Hyper-CVAD | 4 | 56 | |
| other | Viral Infection | Infections and infestations | Hyper-CVAD | 4 | 56 | |
| other | Non-specified infections | Infections and infestations | Hyper-CVAD | 4 | 56 | |
| other | Hypokalemia | Metabolism and nutrition disorders | Hyper-CVAD | 1 | 56 | |
| other | Elevated Alkaline phosphatase (ALT) | Investigations | Hyper-CVAD | 1 | 56 | |
| other | Hemorrhage | General disorders | Hyper-CVAD | 1 | 56 | |
| other | Acute Renal Failure | Renal and urinary disorders | Hyper-CVAD | 1 | 56 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hyper-CVAD | ||
| Total, other adverse events | Hyper-CVAD | 47 | 56 |
| Total, serious adverse events | Hyper-CVAD | 27 | 56 |
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/NCT00669877
GET https://conductscience.org/api/trials/v1/NCT00669877/events?page=2