Trial · NCT00290498
Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger
NCT00290498, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-06-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger. Trials, record NCT00290498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00290498
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger
- NCT number
- NCT00290498
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Lymphoma
- Interventions
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone, Methotrexate, Cytarabine, Prednisone
- First posted
- 2006-02-13
- Last updated
- 2020-06-02
- Results first posted
- 2020-06-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate R-HCVAD vs. R-CHOP | 3 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Progression Free Survival (Rate) | 3 years post-therapy | Progression free survival (PFS) for three years following therapy with Rituxan-HCVAD alternating with Rituximab with high -dose methotrexate/ara-C and standard R-CHOP in patients with newly diagnosed B-cell aggressive non-Hodgkin's lymphomas younger than 60 years old and with adjusted IPI 2 or higher adverse prognostic features. |
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 | Response Rate R-HCVAD vs. R-CHOP | 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival (Rate) | 3 years post-therapy | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate R-HCVAD vs. R-CHOP | R-HCVAD | Complete Remission | 40 | Participants | |
| Response Rate R-HCVAD vs. R-CHOP | R-CHOP | Complete Remission | 7 | Participants | |
| Response Rate R-HCVAD vs. R-CHOP | R-HCVAD | Inevaluable | 2 | Participants | |
| Response Rate R-HCVAD vs. R-CHOP | R-CHOP | Inevaluable | 1 | Participants | |
| Response Rate R-HCVAD vs. R-CHOP | R-HCVAD | Progressive Disease | 1 | Participants | |
| Response Rate R-HCVAD vs. R-CHOP | R-CHOP | Progressive Disease | 1 | Participants | |
| Response Rate R-HCVAD vs. R-CHOP | R-HCVAD | Partial Remission | 4 | Participants | |
| Response Rate R-HCVAD vs. R-CHOP | R-CHOP | Partial Remission | 0 | Participants | |
| Response Rate R-HCVAD vs. R-CHOP | R-HCVAD | Complete Remission Unconfirmed | 2 | Participants | |
| Response Rate R-HCVAD vs. R-CHOP | R-CHOP | Complete Remission Unconfirmed | 1 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | R-HCVAD-MA | 49 | |
| Overall Study | STARTED | R-CHOP | 10 | |
| Overall Study | COMPLETED | R-HCVAD-MA | 41 | |
| Overall Study | COMPLETED | R-CHOP | 10 | |
| Overall Study | NOT COMPLETED | R-HCVAD-MA | 8 | |
| Overall Study | NOT COMPLETED | R-CHOP | 0 |
Source ClinicalTrials.gov
Adverse events346
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 | Neutrophils | Blood and lymphatic system disorders | RHCVAD | 46 | 49 | |
| other | Neutrophils | Blood and lymphatic system disorders | RCHOP | 4 | 10 | |
| other | Platelets | Blood and lymphatic system disorders | RHCVAD | 39 | 49 | |
| other | Platelets | Blood and lymphatic system disorders | RCHOP | 3 | 10 | |
| other | Febrile Neutropenia | Infections and infestations | RHCVAD | 25 | 49 | |
| other | Febrile Neutropenia | Infections and infestations | RCHOP | 2 | 10 | |
| other | Infection | Infections and infestations | RHCVAD | 33 | 49 | |
| other | Infection | Infections and infestations | RCHOP | 5 | 10 | |
| other | Thrombosis/Embolism | Vascular disorders | RHCVAD | 12 | 49 | |
| other | Thrombosis/Embolism | Vascular disorders | RCHOP | 1 | 10 |
1 to 10 of 346Source ClinicalTrials.gov
See all 346 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RHCVAD | 4 | 49 |
| Total, all-cause mortality | RCHOP | 0 | 10 |
| Total, other adverse events | RHCVAD | 46 | 49 |
| Total, other adverse events | RCHOP | 8 | 10 |
| Total, serious adverse events | RHCVAD | 49 | 49 |
| Total, serious adverse events | RCHOP | 7 | 10 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| R-HCVAD/MA vs R-CHOP: Progression Free Survival (Rate) | Trial comparisons |
| RHCVAD vs RCHOP: deaths from any cause | Trial comparisons |
| RHCVAD vs RCHOP: 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/NCT00290498
GET https://conductscience.org/api/trials/v1/NCT00290498/events?page=2