Trial · NCT00069238
Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas
NCT00069238, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-01-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas. Trials, record NCT00069238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00069238
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas
- NCT number
- NCT00069238
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lymphoma, T-Cell, Lymphoma, Extranodal NK-T-Cell
- Interventions
- Alemtuzumab (Campath), EPOCH
- First posted
- 2003-09-18
- Last updated
- 2022-02-24
- Results first posted
- 2016-01-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Alemtuzumab | up to 2 cycles of therapy, approximately 42 days | MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously up to 2 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT). |
| Primary | Number of Participants With Adverse Events | 67 months and 9 days | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Secondary | Clinical Response | From date of onstudy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 67 months and 9 days. | Response was measured by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (Cru)is as per complete remission criterion except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response (PR) is ≥50% decrease in the SPD of 6 largest dominant nodes or nodal masses. Progressive disease (PD) is ≥50% increase from the nadir in the SPD of any previously identified abnormal node for PRS or non-responders. Stable disease (SD) is less than a PR but not progressive disease. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Alemtuzumab | up to 2 cycles of therapy, approximately 42 days | mg | NUMBER | |
| PRIMARY | Number of Participants With Adverse Events | 67 months and 9 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Response | From date of onstudy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 67 months and 9 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Alemtuzumab | All Participants | 30 | mg | ||
| Number of Participants With Adverse Events | All Participants | 31 | Participants | ||
| Clinical Response | All Participants | Complete Response | 17 | Participants | |
| Clinical Response | All Participants | Complete Response Unconfirmed | 0 | Participants | |
| Clinical Response | All Participants | Partial Response | 7 | Participants | |
| Clinical Response | All Participants | Progressive Disease | 2 | Participants | |
| Clinical Response | All Participants | Stable Disease | 1 | Participants | |
| Clinical Response | All Participants | Not Evaluable | 4 | Participants |
Source ClinicalTrials.gov
Participant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort 1 - Dose Level 1 (Weeks 1 - 18) | STARTED | Alemtuzumab 30 mg | 25 | |
| Cohort 1 - Dose Level 1 (Weeks 1 - 18) | STARTED | Alemtuzumab 60 mg | 0 | |
| Cohort 1 - Dose Level 1 (Weeks 1 - 18) | STARTED | Alemtuzumab 90 mg | 0 | |
| Cohort 1 - Dose Level 1 (Weeks 1 - 18) | COMPLETED | Alemtuzumab 30 mg | 16 | |
| Cohort 1 - Dose Level 1 (Weeks 1 - 18) | COMPLETED | Alemtuzumab 60 mg | 0 | |
| Cohort 1 - Dose Level 1 (Weeks 1 - 18) | COMPLETED | Alemtuzumab 90 mg | 0 | |
| Cohort 1 - Dose Level 1 (Weeks 1 - 18) | NOT COMPLETED | Alemtuzumab 30 mg | 9 | |
| Cohort 1 - Dose Level 1 (Weeks 1 - 18) | NOT COMPLETED | Alemtuzumab 60 mg | 0 | |
| Cohort 1 - Dose Level 1 (Weeks 1 - 18) | NOT COMPLETED | Alemtuzumab 90 mg | 0 | |
| Cohort 2 - Dose Level 2 (Weeks 1-18) | STARTED | Alemtuzumab 30 mg | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events183
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 | ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | All Participants | 7 | 31 | 11 |
| other | ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | All Participants | 9 | 31 | 11 |
| other | AUDITORY/EAR:: Otitis, middle ear (non-infectious) | Blood and lymphatic system disorders | All Participants | 1 | 31 | 1 |
| other | AUDITORY/EAR:: Tinnitus | Ear and labyrinth disorders | All Participants | 1 | 31 | 1 |
| other | BLOOD/BONE MARROW:: Bone marrow cellularity | Blood and lymphatic system disorders | All Participants | 4 | 31 | 4 |
| other | BLOOD/BONE MARROW:: Hemoglobin | Blood and lymphatic system disorders | All Participants | 29 | 31 | 101 |
| other | BLOOD/BONE MARROW:: Leukocytes (total white blood count (WBC)) | Blood and lymphatic system disorders | All Participants | 30 | 31 | 121 |
| other | BLOOD/BONE MARROW:: Lymphopenia | Blood and lymphatic system disorders | All Participants | 30 | 31 | 74 |
| other | BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | All Participants | 30 | 31 | 116 |
| other | BLOOD/BONE MARROW:: Platelets | Cardiac disorders | All Participants | 28 | 31 | 102 |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 23 | 31 |
| Total, other adverse events | All Participants | 31 | 31 |
| Total, serious adverse events | All Participants | 23 | 31 |
Source ClinicalTrials.gov
Papers4
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 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/NCT00069238
GET https://conductscience.org/api/trials/v1/NCT00069238/flow?page=2