Trial · NCT00506129
Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
NCT00506129, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma. Trials, record NCT00506129. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00506129
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
- NCT number
- NCT00506129
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Lymphoma, Disorder Related to Bone Marrow Transplantation
- Interventions
- Fludarabine, Melphalan, Allogeneic Transplant, Thymoglobulin
- First posted
- 2007-07-25
- Last updated
- 2020-12-29
- Results first posted
- 2020-12-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) | Response assessed pre-transplant and 100 days post transplant with follow up at 1 year. | Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( \> 90% to \< 100%); only traces of disease remains; 2) Significant improvement ( \> 75% to \< 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( \> 50% to \< 75%); 4) Some improvement ( \> 25% to \< 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+\<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by \> 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one. |
| Secondary | Average Overall Survival (OS) Length | Baseline to disease progression, followed up to 5 years post transplant | OS was defined as the time from transplantation to the date of death from any cause or last follow up, measured in days. |
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 | Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) | Response assessed pre-transplant and 100 days post transplant with follow up at 1 year. | participants | NUMBER | |
| SECONDARY | Average Overall Survival (OS) Length | Baseline to disease progression, followed up to 5 years post transplant | Baseline to disease progression, followed up to 5 years post transplant (assess at 100 days, every 3 months for 2 years, then once a year for at least 3 years) | Days | MEAN |
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 |
|---|---|---|---|---|---|
| Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) | Fludarabine + Melphalan With PBPC | Complete Response (CR) Converted Post Transplant | 19 | participants | |
| Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) | Fludarabine + Melphalan With PBPC | CR Prior to Transplant | 6 | participants | |
| Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) | Fludarabine + Melphalan With PBPC | Partial Response (PR) | 0 | participants | |
| Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) | Fludarabine + Melphalan With PBPC | Stable Disease (SD) | 0 | participants | |
| Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) | Fludarabine + Melphalan With PBPC | Progressive Disease (PD) | 16 | participants | |
| Average Overall Survival (OS) Length | Fludarabine + Melphalan With PBPC | 1207 | Full Range 17 to 1825 | Days |
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 | Fludarabine + Melphalan With PBPC | 33 | |
| Overall Study | COMPLETED | Fludarabine + Melphalan With PBPC | 11 | |
| Overall Study | NOT COMPLETED | Fludarabine + Melphalan With PBPC | 22 |
Source ClinicalTrials.gov
Adverse events51
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 | Primary graft failure with autologous reconstitution | Cardiac disorders | Fludarabine + Melphalan With PBPC | 1 | 33 | 1 |
| other | Cardiac Edema | Cardiac disorders | Fludarabine + Melphalan With PBPC | 6 | 33 | 6 |
| other | Cardiac Function | Cardiac disorders | Fludarabine + Melphalan With PBPC | 1 | 33 | 1 |
| other | Hypertension | Vascular disorders | Fludarabine + Melphalan With PBPC | 7 | 33 | 7 |
| other | Congestive heart failure | Cardiac disorders | Fludarabine + Melphalan With PBPC | 1 | 33 | 1 |
| other | Chest pain | Cardiac disorders | Fludarabine + Melphalan With PBPC | 1 | 33 | 1 |
| other | pericarditis | Cardiac disorders | Fludarabine + Melphalan With PBPC | 1 | 33 | 1 |
| other | tachycardia | Cardiac disorders | Fludarabine + Melphalan With PBPC | 2 | 33 | 2 |
| other | fever | General disorders | Fludarabine + Melphalan With PBPC | 8 | 33 | 8 |
| other | fatigue | General disorders | Fludarabine + Melphalan With PBPC | 5 | 33 | 5 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fludarabine + Melphalan With PBPC | ||
| Total, other adverse events | Fludarabine + Melphalan With PBPC | 33 | 33 |
| Total, serious adverse events | Fludarabine + Melphalan With PBPC | 0 | 33 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26416896 | DERIVED |
Source PubMed
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/NCT00506129
GET https://conductscience.org/api/trials/v1/NCT00506129/events?page=2