Trial · NCT00496340
Phase II Trial of Pentostatin and Targeted Busulfan
NCT00496340, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2014-06-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Phase II Trial of Pentostatin and Targeted Busulfan. Trials, record NCT00496340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00496340
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial of Pentostatin and Targeted Busulfan
- NCT number
- NCT00496340
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Hematologic Malignancies
- Interventions
- Pentostatin, Busulfan, Rituximab, Allogeneic Hematopoietic Cell Transplant
- First posted
- 2007-07-04
- Last updated
- 2014-06-05
- Results first posted
- 2014-06-05
- Limitations and caveats
- Bone marrow chimerism data were available for only 38 patients at day +28 and for only 36 patients at day +100.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Greater Than or Equal to 50% Donor Chimerism | 28 days post-transplant | The primary endpoint was achievement of \>/= 50% donor chimerism in CD3+ peripheral blood lymphocytes by day +28 (± 7) after allogeneic hematopoietic cell transplantation (allo-HCT). |
| Secondary | Cumulative Incidence of Hematopoietic Cell Engraftment | 28 days post-transplant | Hematologic engraftment: defined as time to achieve an absolute neutrophil count (ANC) \>/= 500/µl for 3 consecutive days or a platelet count of \>/= 20,000//µl without the need for platelet support. |
| Secondary | Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28 | 28 days post-transplant | Median Percentage of Donor Cells in Study Population (Chimerism). |
| Secondary | Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100 | 100 days post-transplant | Median Percentage of Donor Cells in Study Population (Chimerism). |
| Secondary | Non-relapse Mortality Rate (NRM) | Up to 2 years post-transplant | The cumulative incidence of NRM after allo-HCT. |
| Secondary | Incidence of Infections | Up to 2 years post-transplant | Infections: Incidence of infections (opportunistic and non-opportunistic) following conditioning. |
| Secondary | Time to Incidence of Graft Versus Host Disease (GVHD) | Up to 2 years post-transplant | The median time from allo-HCT to the initiation of tacrolimus (TAC) taper. The median time to onset of acute GVHD (aGVHD). Clinical manifestations of acute GVHD include a classic maculopapular rash; persistent nausea and/or emesis; abdominal cramps with diarrhea; and a rising serum bilirubin concentration. |
| Secondary | Incidence of Graft Versus Host Disease (GVHD) | Up to 2 years post-transplant | By day +100, the cumulative incidence of GVHD, acute of grades 2-4, and 3-4. At 2 years, the cumulative incidence of chronic GVHD of any severity according to National Institutes of Health (NIH) consensus criteria. Diagnosis of chronic GVHD requires the presence of at least one diagnostic clinical sign of chronic GVHD or the presence of at least one distinctive manifestation confirmed by pertinent biopsy or other relevant tests in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD. At 2 years, the cumulative incidence of moderate/severe chronic GVHD. |
| Secondary | Percentage of Participants With Progression Free Survival (PFS) | 2 years post-transplant | PFS at 2 years post-transplant. PFS, defined as time from day of hematopoietic cell infusion to disease relapse. Relapsed disease: Disease was in complete remission post-transplant but returned (e.g., \>5% blast in bone marrow or any peripheral blasts). |
| Secondary | Percentage of Participants With Overall Survival (OS) | 2 years post-transplant | OS at 2 years post-transplant. OS, defined as time from day of hematopoietic cell infusion to death from any cause. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Greater Than or Equal to 50% Donor Chimerism | 28 days post-transplant | All participants | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Hematopoietic Cell Engraftment | 28 days post-transplant | All participants | percentage of participants | NUMBER |
| SECONDARY | Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28 | 28 days post-transplant | Participants with bone marrow chimerism data available at time of analysis. | percentage of cells | MEDIAN |
| SECONDARY | Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100 | 100 days post-transplant | Participants with bone marrow chimerism data available at time of analysis. | percentage of cells | MEDIAN |
| SECONDARY | Non-relapse Mortality Rate (NRM) | Up to 2 years post-transplant | All participants | percentage of participants | NUMBER |
| SECONDARY | Incidence of Infections | Up to 2 years post-transplant | All participants | participants | NUMBER |
| SECONDARY | Time to Incidence of Graft Versus Host Disease (GVHD) | Up to 2 years post-transplant | All participants | days | MEDIAN |
| SECONDARY | Incidence of Graft Versus Host Disease (GVHD) | Up to 2 years post-transplant | All participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Progression Free Survival (PFS) | 2 years post-transplant | All participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Survival (OS) | 2 years post-transplant | All participants | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Greater Than or Equal to 50% Donor Chimerism | Conditioning Followed by HCT | 100 | percentage of participants | ||
| Cumulative Incidence of Hematopoietic Cell Engraftment | Conditioning Followed by HCT | 97.6 | 95% Confidence Interval 90.6 to 100 | percentage of participants | |
| Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28 | Conditioning Followed by HCT | CD3+ | 87 | 95% Confidence Interval 61 to 100 | percentage of cells |
| Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28 | Conditioning Followed by HCT | CD33+ | 100 | 95% Confidence Interval 95 to 100 | percentage of cells |
| Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100 | Conditioning Followed by HCT | CD3+ | 96 | 95% Confidence Interval 64 to 100 | percentage of cells |
| Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100 | Conditioning Followed by HCT | CD33+ | 100 | 95% Confidence Interval 100 to 100 | percentage of cells |
| Non-relapse Mortality Rate (NRM) | Conditioning Followed by HCT | Day +100 | 2 | 95% Confidence Interval 0 to 9 | percentage of participants |
| Non-relapse Mortality Rate (NRM) | Conditioning Followed by HCT | 2 Years | 17 | 95% Confidence Interval 7 to 30 | percentage of participants |
| Incidence of Infections | Conditioning Followed by HCT | Cytomegalovirus (CMV) Reactivation | 17 | participants | |
| Incidence of Infections | Conditioning Followed by HCT | Epstein-Barr virus (EBV) Reactivation | 3 | participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Conditioning Followed by HCT | 42 | |
| Overall Study | COMPLETED | Conditioning Followed by HCT | 42 | |
| Overall Study | NOT COMPLETED | Conditioning Followed by HCT | 0 |
Source ClinicalTrials.gov
Adverse events47
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 |
|---|---|---|---|---|---|---|
| serious | Blood/Bone Marrow - Other, Complications with GVHD | Blood and lymphatic system disorders | Conditioning Followed by HCT | 1 | 42 | |
| serious | Cardiac General - Other, Cardiac arrest | Cardiac disorders | Conditioning Followed by HCT | 1 | 42 | |
| serious | Pericardial effusion (non-malignant) | Cardiac disorders | Conditioning Followed by HCT | 1 | 42 | |
| serious | Coagulation - Other, Right jugular vein occlusion | Blood and lymphatic system disorders | Conditioning Followed by HCT | 2 | 42 | |
| serious | Thrombotic microangiopathy | Blood and lymphatic system disorders | Conditioning Followed by HCT | 2 | 42 | |
| serious | Fever (in the absence of neutropenia) | General disorders | Conditioning Followed by HCT | 1 | 42 | |
| serious | Death not associated with CTCAE term - Death NOS | General disorders | Conditioning Followed by HCT | 5 | 42 | |
| serious | Dermatology/Skin - Other, Shingles reactivation | Skin and subcutaneous tissue disorders | Conditioning Followed by HCT | 1 | 42 | |
| serious | Pruritus/itching | Skin and subcutaneous tissue disorders | Conditioning Followed by HCT | 1 | 42 | |
| serious | Pancreatic endocrine: glucose intolerance | Endocrine disorders | Conditioning Followed by HCT | 1 | 42 |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Conditioning Followed by HCT | ||
| Total, other adverse events | Conditioning Followed by HCT | 0 | 42 |
| Total, serious adverse events | Conditioning Followed by HCT | 25 | 42 |
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/NCT00496340
GET https://conductscience.org/api/trials/v1/NCT00496340/results?page=2