Trial · NCT01445535
Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas
NCT01445535, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2020-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas. Trials, record NCT01445535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01445535
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas
- NCT number
- NCT01445535
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- T-Cell Peripheral Lymphoma, Gamma Delta Hepatosplenic T-Cell Lymphoma, Subcutaneous Panniculitis-Like T-Cell Lymphoma, NK T-Cell Lymphoma
- Interventions
- Rituximab, Etoposide, Siplizumab, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin
- First posted
- 2011-10-03
- Last updated
- 2021-11-03
- Results first posted
- 2020-08-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Serious and Non-serious Adverse Events | Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks. | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Primary | Maximum Tolerated Dose (MTD) of Siplizumab | First 30 days after treatment initiation. | A classic 3+3 dose-escalation design was used to assess the MTD of siplizumab in combination with dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). If 2 of 6 patients experienced a dose-limiting toxicity (DLT) at a particular dose level, the MTD has been exceeded. The preceding dose level will be the MTD, provided 6 patients have been entered at this level and no more than one has experienced a DLT. DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an Epstein Barr Virus (EBV)-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted EPOCH-R and grade 3 laboratory adverse events (AEs) were not considered to be DLTs. |
| Secondary | Number of Participants With a Response to Therapy | Response assessments were performed after the fourth and sixth cycle of therapy, at therapy completion, and every 3 months for year 1, four months for year 2, 6 months for years 3-5, and annually thereafter, up to 5 years. | Response was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete Remission was defined as the disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (for example lactate dehydrogenase (LDH)) definitely assignable to the lymphoma. Complete response unconfirmed was defined as a residual node greater than 1.5 cm, with a decrease by greater than 75 percent in the sum of the products of the perpendicular diameters (SPD) of all measured lymph nodes. Partial Response was defined as a ≥ 50% decreased in SPD of 6 largest dominant nodes or nodal masses. Relapsed disease was defined as the appearance of any new lesion or increase by ≥50% in the size of the previously identified sites. Progressive disease was defined as a ≥50% increase from nadir in the SPD. |
| Secondary | Overall Progression Free Survival (PFS) | On-study date until date of progression or last follow up, approximately 7 months. | Progression was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Progression is defined as ≥50% increase from nadir in the sum of the products of the perpendicular diameters (SPD) of any previously identified abnormal nodes for Partial Response's or non-responders. Progression-free survival (PFS) was determined from the on-study date until date of progression or last follow-up. The probability of PFS as a function of time was estimated by the Kaplan-Meier method. |
| Secondary | Overall Survival (OS) | On study date until date of death or last follow up, approximately 12 months. | Overall survival was determined from the on-study date until date of progression or last follow up. The probability of OS as a function of time was estimated by the Kaplan-Meier method. |
| Other | Number of Dose-Limiting Toxicities (DLT) | First 30 days after treatment initiation. | DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an EBV-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) and grade 3 laboratory AEs were not considered to be DLTs. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Serious and Non-serious Adverse Events | Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Maximum Tolerated Dose (MTD) of Siplizumab | First 30 days after treatment initiation. | mg/kg | NUMBER | |
| SECONDARY | Number of Participants With a Response to Therapy | Response assessments were performed after the fourth and sixth cycle of therapy, at therapy completion, and every 3 months for year 1, four months for year 2, 6 months for years 3-5, and annually thereafter, up to 5 years. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Progression Free Survival (PFS) | On-study date until date of progression or last follow up, approximately 7 months. | Data collected from participants receiving different dose levels were combined and analyzed as a single Arm/Group as pre-specified in the study protocol. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | On study date until date of death or last follow up, approximately 12 months. | Data collected from participants receiving different dose levels were combined and analyzed as a single Arm/Group as pre-specified in the study protocol. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Dose-Limiting Toxicities (DLT) | First 30 days after treatment initiation. | Dose Limiting Toxicities | NUMBER |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Serious and Non-serious Adverse Events | Cohort 1 - 3.4 mg/kg | 3 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events | Cohort 2 - 4.8 mg/kg | 3 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events | Cohort 3 - 8.5 mg/kg | 3 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events | Cohort 4 - 15 mg/kg | 5 | Participants | ||
| Maximum Tolerated Dose (MTD) of Siplizumab | All Participants | 15 | mg/kg | ||
| Number of Participants With a Response to Therapy | Cohort 1 - 3.4 mg/kg | Complete Remission | 1 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 2 - 4.8 mg/kg | Complete Remission | 2 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 3 - 8.5 mg/kg | Complete Remission | 1 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 4 - 15 mg/kg | Complete Remission | 4 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 1 - 3.4 mg/kg | Complete Response Unconfirmed | 0 | Participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 - 3.4 mg/kg | 3 | |
| Overall Study | STARTED | Cohort 2 - 4.8 mg/kg | 3 | |
| Overall Study | STARTED | Cohort 3 - 8.5 mg/kg | 3 | |
| Overall Study | STARTED | Cohort 4 - 15 mg/kg | 6 | |
| Overall Study | COMPLETED | Cohort 1 - 3.4 mg/kg | 2 | |
| Overall Study | COMPLETED | Cohort 2 - 4.8 mg/kg | 3 | |
| Overall Study | COMPLETED | Cohort 3 - 8.5 mg/kg | 2 | |
| Overall Study | COMPLETED | Cohort 4 - 15 mg/kg | 4 | |
| Overall Study | NOT COMPLETED | Cohort 1 - 3.4 mg/kg | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2 - 4.8 mg/kg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events400
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 | Alkaline phosphatase | Metabolism and nutrition disorders | Cohort 1 - 3.4 mg/kg | 1 | 3 | 1 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Cohort 2 - 4.8 mg/kg | 0 | 3 | 0 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Cohort 3 - 8.5 mg/kg | 0 | 3 | 0 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Cohort 4 - 15 mg/kg | 2 | 6 | 3 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Cohort 1 - 3.4 mg/kg | 1 | 3 | 2 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Cohort 2 - 4.8 mg/kg | 2 | 3 | 2 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Cohort 3 - 8.5 mg/kg | 2 | 3 | 2 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Cohort 4 - 15 mg/kg | 0 | 6 | 0 |
| other | Anorexia | Gastrointestinal disorders | Cohort 1 - 3.4 mg/kg | 1 | 3 | 2 |
| other | Anorexia | Gastrointestinal disorders | Cohort 2 - 4.8 mg/kg | 2 | 3 | 2 |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - 3.4 mg/kg | 2 | 3 |
| Total, all-cause mortality | Cohort 2 - 4.8 mg/kg | 3 | 3 |
| Total, all-cause mortality | Cohort 3 - 8.5 mg/kg | 3 | 3 |
| Total, all-cause mortality | Cohort 4 - 15 mg/kg | 4 | 6 |
| Total, other adverse events | Cohort 1 - 3.4 mg/kg | 3 | 3 |
| Total, other adverse events | Cohort 2 - 4.8 mg/kg | 3 | 3 |
| Total, other adverse events | Cohort 3 - 8.5 mg/kg | 3 | 3 |
| Total, other adverse events | Cohort 4 - 15 mg/kg | 5 | 6 |
| Total, serious adverse events | Cohort 1 - 3.4 mg/kg | 0 | 3 |
| Total, serious adverse events | Cohort 2 - 4.8 mg/kg | 2 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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/NCT01445535
GET https://conductscience.org/api/trials/v1/NCT01445535/results?page=2