Trial · NCT00337987
A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma
NCT00337987, Phase 2, Completed, Yale University; results first posted 2015-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma. Trials, record NCT00337987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00337987
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma
- NCT number
- NCT00337987
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Peripheral T-Cell Lymphoma
- Interventions
- Ontak, CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy
- First posted
- 2006-06-20
- Last updated
- 2015-02-27
- Results first posted
- 2015-02-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients That Achieved a Complete Response or a Partial Response (PR) | After 4 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 |
| Primary | Number of Patients That Achieved a Complete Response (CR) | After 4 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 |
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 | Number of Patients That Achieved a Complete Response or a Partial Response (PR) | After 4 years | participants | NUMBER | |
| PRIMARY | Number of Patients That Achieved a Complete Response (CR) | After 4 years | 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 |
|---|---|---|---|---|---|
| Number of Patients That Achieved a Complete Response or a Partial Response (PR) | Denileukin Diftitox/CHOP Administration | 32 | participants | ||
| Number of Patients That Achieved a Complete Response (CR) | Denileukin Diftitox/CHOP Administration | 27 | 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 | Denileukin Diftitox/CHOP Administration | 49 | |
| Overall Study | COMPLETED | Denileukin Diftitox/CHOP Administration | 49 | |
| Overall Study | NOT COMPLETED | Denileukin Diftitox/CHOP Administration | 0 |
Source ClinicalTrials.gov
Adverse events33
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 | Denileukin Diftitox/CHOP Administration | 20 | 49 | |
| other | Leukocytopenia | Blood and lymphatic system disorders | Denileukin Diftitox/CHOP Administration | 17 | 49 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Denileukin Diftitox/CHOP Administration | 15 | 49 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Denileukin Diftitox/CHOP Administration | 14 | 49 | |
| other | Neutropenia | Blood and lymphatic system disorders | Denileukin Diftitox/CHOP Administration | 13 | 49 | |
| other | Fatigue | General disorders | Denileukin Diftitox/CHOP Administration | 31 | 49 | |
| other | Nausea | Gastrointestinal disorders | Denileukin Diftitox/CHOP Administration | 23 | 49 | |
| other | Neuropathy, sensory | Musculoskeletal and connective tissue disorders | Denileukin Diftitox/CHOP Administration | 20 | 49 | |
| other | Alanine Aminotransferase (ALT) Elevated | Blood and lymphatic system disorders | Denileukin Diftitox/CHOP Administration | 17 | 49 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | Denileukin Diftitox/CHOP Administration | 17 | 49 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Denileukin Diftitox/CHOP Administration | ||
| Total, other adverse events | Denileukin Diftitox/CHOP Administration | 42 | 49 |
| Total, serious adverse events | Denileukin Diftitox/CHOP Administration | 25 | 49 |
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/NCT00337987
GET https://conductscience.org/api/trials/v1/NCT00337987/events?page=2