Trial · NCT00896493
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
NCT00896493, Phase 2, Completed, Stanford University; results first posted 2023-05-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma. Trials, record NCT00896493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00896493
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
- NCT number
- NCT00896493
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Mycoses, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous, Bone Marrow Transplant Failure, Lymphoma, Non-Hodgkin, Cutaneous T-cell Lymphoma
- Interventions
- anti-thymocyte globulin, cyclosporine, Lymphoid radiation
- First posted
- 2009-05-11
- Last updated
- 2023-05-11
- Results first posted
- 2023-05-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) at 180 Days | 180 days | Progression-Free Survival (PFS; time to disease progression or death from any cause) assessed at 180 days (Kaplan-Meier estimate). Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Number of Participants With Acute Graft-versus-host Disease (GVHD) | 6 months | Cumulative incidence at 6 months. GvHD was assessed using the 2015 NIH consensus criteria. |
| Secondary | Number of Participants With Chronic Graft-versus-host Disease (GVHD) | 2 years | Cumulative incidence at 6 months (any grade). GvHD was assessed using the 2015 NIH consensus criteria. |
| Secondary | Overall Survival (OS) | 2 years | Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate). |
| Secondary | Overall Survival (OS) | 5 years | Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate). |
| Secondary | Mortality | Up to 5 years | Total count of non-relapsed mortality and mortality from relapsed disease. |
| Secondary | Treatment Related Mortality | Up to 5 years | |
| Secondary | Event Free Survival (EFS) | 2 years | Event-free survival (EFS) is the time measurement between the day of allogeneic transplant and the first documented recurrence or death from any cause (Kaplan-Meier estimate). |
| Secondary | Event Free Survival (EFS) | 5 years | Event-free survival (EFS) is the time measurement between the day of allogeneic transplant and the first documented recurrence or death from any cause (Kaplan-Meier estimate). |
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 | Progression-Free Survival (PFS) at 180 Days | 180 days | Participants who completed assigned treatment | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Acute Graft-versus-host Disease (GVHD) | 6 months | Participants who completed assigned treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Chronic Graft-versus-host Disease (GVHD) | 2 years | Participants who completed assigned treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | 2 years | Participants who completed assigned treatment | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | 5 years | Participants who completed assigned treatment | percentage of participants | NUMBER |
| SECONDARY | Mortality | Up to 5 years | Participants who completed assigned treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Related Mortality | Up to 5 years | Participants who completed assigned treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Event Free Survival (EFS) | 2 years | Participants who completed assigned treatment | percentage of participants | NUMBER |
| SECONDARY | Event Free Survival (EFS) | 5 years | Participants who completed assigned treatment | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) at 180 Days | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 73 | 95% Confidence Interval 55 to 85 | percentage of participants | |
| Number of Participants With Acute Graft-versus-host Disease (GVHD) | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | Any Grade | 9 | Participants | |
| Number of Participants With Acute Graft-versus-host Disease (GVHD) | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | Grade II-IV | 5 | Participants | |
| Number of Participants With Chronic Graft-versus-host Disease (GVHD) | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 9 | Participants | ||
| Overall Survival (OS) | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 68 | 95% Confidence Interval 50 to 81 | percentage of participants | |
| Overall Survival (OS) | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 56 | 95% Confidence Interval 38 to 71 | percentage of participants | |
| Mortality | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | Non-relaped, treatment related | 5 | Participants | |
| Mortality | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | Non-relaped, not treatment related | 1 | Participants | |
| Mortality | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | Disease relapse | 15 | Participants | |
| Treatment Related Mortality | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | Acute GVHD | 1 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 38 | |
| Overall Study | Completed Assigned Treatment | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 35 | |
| Overall Study | COMPLETED | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 35 | |
| Overall Study | NOT COMPLETED | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 3 |
Source ClinicalTrials.gov
Adverse events22
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 | Serum sickness | Injury, poisoning and procedural complications | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 3 | 38 | |
| other | Disease Relapse | General disorders | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 20 | 38 | |
| other | Secondary Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 2 | 38 | |
| other | Anemia | Blood and lymphatic system disorders | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 16 | 38 | |
| other | Neutropenia | Blood and lymphatic system disorders | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 6 | 38 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 2 | 38 | |
| other | Neutropenic fever | Infections and infestations | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 3 | 38 | |
| other | Infection, non-specified | Infections and infestations | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 4 | 38 | |
| other | Vaginal bleeding | Reproductive system and breast disorders | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 1 | 38 | |
| other | Post transplant lymphoproliferative disorder (PTLD) | Infections and infestations | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 2 | 38 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 21 | 38 |
| Total, other adverse events | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 20 | 38 |
| Total, serious adverse events | Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin | 7 | 38 |
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/NCT00896493
GET https://conductscience.org/api/trials/v1/NCT00896493/events?page=2