Trial · NCT00948090
PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
NCT00948090, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2014-07-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients. Trials, record NCT00948090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00948090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
- NCT number
- NCT00948090
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 207 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Lymphoma
- Interventions
- IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)
- First posted
- 2009-07-29
- Last updated
- 2014-07-31
- Results first posted
- 2014-07-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Progression Events in 2 Years. | 2 years | The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease. |
| Secondary | Number of Death Events in 2 Years. | 2 years | The time of overall survival was defined as the time from transplantation to death of all causes. |
| Secondary | Number of Transplant-related Death Events Until Day 100. | Day 100 | Transplant-related mortality was defined as death due to any cause other than disease relapse/progression up until Day 100. |
| Secondary | Overall Response Rate | Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination) | The overall response status is complete response and not complete response (partial remission, primary refractory/primary induction failure, stable disease, progressive disease, and relapse) at Baseline and each of the scheduled follow-up time points. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Progression Events in 2 Years. | 2 years | Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the Intent-to-treat (ITT) data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set. | Event | NUMBER |
| SECONDARY | Number of Death Events in 2 Years. | 2 years | Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set. | Deaths | NUMBER |
| SECONDARY | Number of Transplant-related Death Events Until Day 100. | Day 100 | Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set. | Transplant-related death | NUMBER |
| SECONDARY | Overall Response Rate | Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination) | Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Progression Events in 2 Years. | Hodgkin's Lymphoma (≤ 65 Years) | 41 | Event | ||
| Number of Progression Events in 2 Years. | Hodgkin's Lymphoma (> 65 Years) | 1 | Event | ||
| Number of Progression Events in 2 Years. | Non-Hodgkin's Lymphoma (≤ 65 Years) | 46 | Event | ||
| Number of Progression Events in 2 Years. | Non-Hodgkin's Lymphoma (> 65 Years) | 8 | Event | ||
| Number of Death Events in 2 Years. | Hodgkin's Lymphoma (≤ 65 Years) | 13 | Deaths | ||
| Number of Death Events in 2 Years. | Hodgkin's Lymphoma (> 65 Years) | 1 | Deaths | ||
| Number of Death Events in 2 Years. | Non-Hodgkin's Lymphoma (≤ 65 Years) | 28 | Deaths | ||
| Number of Death Events in 2 Years. | Non-Hodgkin's Lymphoma (> 65 Years) | 6 | Deaths | ||
| Number of Transplant-related Death Events Until Day 100. | Hodgkin's Lymphoma (≤ 65 Years) | 1 | Transplant-related death | ||
| Number of Transplant-related Death Events Until Day 100. | Hodgkin's Lymphoma (> 65 Years) | 1 | Transplant-related death |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hodgkin's Lymphoma (≤ 65 Years) | 65 | |
| Overall Study | STARTED | Hodgkin's Lymphoma (> 65 Years) | 1 | |
| Overall Study | STARTED | Non-Hodgkin's Lymphoma (≤ 65 Years) | 123 | |
| Overall Study | STARTED | Non-Hodgkin's Lymphoma (> 65 Years) | 18 | |
| Overall Study | COMPLETED | Hodgkin's Lymphoma (≤ 65 Years) | 22 | |
| Overall Study | COMPLETED | Hodgkin's Lymphoma (> 65 Years) | 0 | |
| Overall Study | COMPLETED | Non-Hodgkin's Lymphoma (≤ 65 Years) | 67 | |
| Overall Study | COMPLETED | Non-Hodgkin's Lymphoma (> 65 Years) | 7 | |
| Overall Study | NOT COMPLETED | Hodgkin's Lymphoma (≤ 65 Years) | 43 | |
| Overall Study | NOT COMPLETED | Hodgkin's Lymphoma (> 65 Years) | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events205
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 | Anaemia | Blood and lymphatic system disorders | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 22 | 207 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 129 | 207 | |
| other | Neutropenia | Blood and lymphatic system disorders | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 23 | 207 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 27 | 207 | |
| other | Atrial fibrillation | Cardiac disorders | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 12 | 207 | |
| other | Sinus tachycardia | Cardiac disorders | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 12 | 207 | |
| other | Tachycardia | Cardiac disorders | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 39 | 207 | |
| other | Dry eye | Eye disorders | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 12 | 207 | |
| other | Abdominal distension | Gastrointestinal disorders | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 19 | 207 | |
| other | Abdominal pain | Gastrointestinal disorders | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 61 | 207 |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | ||
| Total, other adverse events | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 190 | 207 |
| Total, serious adverse events | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | 90 | 207 |
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/NCT00948090
GET https://conductscience.org/api/trials/v1/NCT00948090/results?page=2