Trial · NCT00389818
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma
NCT00389818, Phase 2, Completed, AIDS Malignancy Consortium; results first posted 2012-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma. Trials, record NCT00389818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00389818
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma
- NCT number
- NCT00389818
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- AIDS Malignancy Consortium
- Conditions
- Lymphoma
- Interventions
filgrastim, pegfilgrastim, rituximab, sargramostim, cyclophosphamide, pegylated liposomal doxorubicin hydrochloride, prednisone, vincristine sulfate, immunohistochemistry staining method, laboratory biomarker analysis
- First posted
- 2006-10-19
- Last updated
- 2018-06-06
- Results first posted
- 2012-06-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI . | After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation | |
| Primary | Duration of Response | After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation | |
| Primary | Median Survival Time | After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation | |
| Primary | Rate of Bacterial, Fungal, and Opportunistic Infections | After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation | |
| Secondary | Relationship Between MDR-1 Expression and Response to Treatment | Baseline | |
| Secondary | Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue | Baseline, after cycles 4 and 6, 1 month after treatment discontinuation | |
| Secondary | Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time | After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation | |
| Secondary | Mortality and Cause of Death | At any time through the third year after treatment discontinuation | |
| Secondary | Event-free Survival at 1 Year | 1 year post-treatment |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI . | After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation | proportion of patients | NUMBER | |
| PRIMARY | Duration of Response | After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation | |||
| PRIMARY | Median Survival Time | After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation | |||
| PRIMARY | Rate of Bacterial, Fungal, and Opportunistic Infections | After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation | |||
| SECONDARY | Relationship Between MDR-1 Expression and Response to Treatment | Baseline | |||
| SECONDARY | Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue | Baseline, after cycles 4 and 6, 1 month after treatment discontinuation | |||
| SECONDARY | Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time | After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation | |||
| SECONDARY | Mortality and Cause of Death | At any time through the third year after treatment discontinuation | |||
| SECONDARY | Event-free Survival at 1 Year | 1 year post-treatment |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI . | DR-COP | 0.475 | 95% Confidence Interval 0.315 to 0.639 | proportion of patients |
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 | DR-COP | 43 | |
| Overall Study | COMPLETED | DR-COP | 40 | |
| Overall Study | NOT COMPLETED | DR-COP | 3 |
Source ClinicalTrials.gov
Adverse events103
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 | DR-COP | 13 | 40 | 19 |
| other | Abdominal pain | Gastrointestinal disorders | DR-COP | 5 | 40 | 6 |
| other | Nausea | Gastrointestinal disorders | DR-COP | 13 | 40 | 19 |
| other | Vomiting | Gastrointestinal disorders | DR-COP | 12 | 40 | 17 |
| other | Blood and lymphatic system disorders, other | Blood and lymphatic system disorders | DR-COP | 3 | 40 | 6 |
| other | Sinus tachycardia | Cardiac disorders | DR-COP | 2 | 40 | 2 |
| other | Ear and labyrinth disorders, other | Ear and labyrinth disorders | DR-COP | 2 | 40 | 2 |
| other | Constipation | Gastrointestinal disorders | DR-COP | 11 | 40 | 14 |
| other | Diarrhea | Gastrointestinal disorders | DR-COP | 7 | 40 | 8 |
| other | Dysphagia | Gastrointestinal disorders | DR-COP | 3 | 40 | 3 |
1 to 10 of 103Source ClinicalTrials.gov
See all 103 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DR-COP | ||
| Total, other adverse events | DR-COP | 38 | 40 |
| Total, serious adverse events | DR-COP | 26 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23169503 | RESULT |
Source PubMed
Grants1
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 |
|---|---|---|---|---|---|
| U01CA070019 | AMC OPERATIONS CENTER | LEE, JEANNETTE Y. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | NATIONAL CANCER INSTITUTE | 1995 to 2005 |
Source 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/NCT00389818
GET https://conductscience.org/api/trials/v1/NCT00389818/events?page=2