Trial · NCT00054665
PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma
NCT00054665, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2012-09-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma. Trials, record NCT00054665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00054665
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma
- NCT number
- NCT00054665
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- B-Cell Lymphoma
- Interventions
- PS-341, Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone, Filgrastim
- First posted
- 2003-02-06
- Last updated
- 2012-09-11
- Results first posted
- 2012-09-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response Rate | 18 weeks | Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease |
| Primary | Number of Participants With Adverse Events | 43 months | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
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 | Clinical Response Rate | 18 weeks | Participants | NUMBER | |
| PRIMARY | Number of Participants With Adverse Events | 43 months | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response Rate | Part A: PS-341 Alone | Partial response | 1 | Participants | |
| Clinical Response Rate | Part B: PS-341 & EPOCH | Partial response | 7 | Participants | |
| Clinical Response Rate | Part A: PS-341 Alone | Complete response | 0 | Participants | |
| Clinical Response Rate | Part B: PS-341 & EPOCH | Complete response | 8 | Participants | |
| Number of Participants With Adverse Events | Part A: PS-341 Alone | 23 | Participants | ||
| Number of Participants With Adverse Events | Part B: PS-341 & EPOCH | 44 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Part A: PS-341 Alone | 23 | |
| Part A | STARTED | Part B: PS-341 & EPOCH | 0 | |
| Part A | COMPLETED | Part A: PS-341 Alone | 23 | |
| Part A | COMPLETED | Part B: PS-341 & EPOCH | 0 | |
| Part A | NOT COMPLETED | Part A: PS-341 Alone | 0 | |
| Part A | NOT COMPLETED | Part B: PS-341 & EPOCH | 0 | |
| Part B | STARTED | Part A: PS-341 Alone | 0 | |
| Part B | STARTED | Part B: PS-341 & EPOCH | 44 | |
| Part B | COMPLETED | Part A: PS-341 Alone | 0 | |
| Part B | COMPLETED | Part B: PS-341 & EPOCH | 44 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events386
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 | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Part A: PS-341 Alone | 1 | 24 | 1 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Part B: PS-341 & EPOCH | 2 | 44 | 2 |
| other | Hemoglobin | Blood and lymphatic system disorders | Part A: PS-341 Alone | 5 | 24 | 5 |
| other | Hemoglobin | Blood and lymphatic system disorders | Part B: PS-341 & EPOCH | 26 | 44 | 40 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Part A: PS-341 Alone | 5 | 24 | 5 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Part B: PS-341 & EPOCH | 25 | 44 | 48 |
| other | Lymphopenia | Blood and lymphatic system disorders | Part A: PS-341 Alone | 6 | 24 | 8 |
| other | Lymphopenia | Blood and lymphatic system disorders | Part B: PS-341 & EPOCH | 14 | 44 | 22 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Part A: PS-341 Alone | 2 | 24 | 2 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Part B: PS-341 & EPOCH | 26 | 44 | 46 |
1 to 10 of 386Source ClinicalTrials.gov
See all 386 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: PS-341 Alone | ||
| Total, all-cause mortality | Part B: PS-341 & EPOCH | ||
| Total, other adverse events | Part A: PS-341 Alone | 24 | 24 |
| Total, other adverse events | Part B: PS-341 & EPOCH | 44 | 44 |
| Total, serious adverse events | Part A: PS-341 Alone | 21 | 24 |
| Total, serious adverse events | Part B: PS-341 & EPOCH | 40 | 44 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part A: PS-341 Alone vs Part B: PS-341 & EPOCH: Number of Participants With Adverse Events | Trial comparisons |
| Part A: PS-341 Alone vs Part B: PS-341 & EPOCH: 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/NCT00054665
GET https://conductscience.org/api/trials/v1/NCT00054665/events?page=2