Trial · NCT00134004
Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
NCT00134004, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2015-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer. Trials, record NCT00134004. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00134004
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
- NCT number
- NCT00134004
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 210 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Interventions
- cyclophosphamide, fludarabine phosphate, mycophenolate mofetil, tacrolimus, allogeneic bone marrow transplantation, radiation therapy
- First posted
- 2005-08-24
- Last updated
- 2015-10-06
- Results first posted
- 2015-08-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Transplant-related Mortality | Cumulative incidence for the entire study, up to 11 years | Percentage of participants who die for any reason other than recurrence of disease. |
| Primary | Relapse Rate | Cumulative incidence for the entire study, up to 11 years | Percentage of participants who experience disease relapse. |
| Primary | Progression-free Survival | 2 years | Percentage of participants who do not experience disease relapse, disease progression, or death. |
| Secondary | Graft Failure Rate | Cumulative incidence for the entire study, up to 11 years | Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as \<5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure. |
| Secondary | Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation | 1 year | Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Transplant-related Mortality | Cumulative incidence for the entire study, up to 11 years | percentage of participants | NUMBER | |
| PRIMARY | Relapse Rate | Cumulative incidence for the entire study, up to 11 years | percentage of participants | NUMBER | |
| PRIMARY | Progression-free Survival | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Graft Failure Rate | Cumulative incidence for the entire study, up to 11 years | percentage of participants | NUMBER | |
| SECONDARY | Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation | 1 year | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Transplant-related Mortality | Mini-haplo BMT | 18 | percentage of participants | ||
| Relapse Rate | Mini-haplo BMT | 55 | percentage of participants | ||
| Progression-free Survival | Mini-haplo BMT | 34 | percentage of participants | ||
| Graft Failure Rate | Mini-haplo BMT | 13 | percentage of participants | ||
| Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation | Mini-haplo BMT | 9.5 | percentage of participants |
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 | Mini-haplo BMT | 210 | |
| Overall Study | COMPLETED | Mini-haplo BMT | 210 | |
| Overall Study | NOT COMPLETED | Mini-haplo BMT | 0 |
Source ClinicalTrials.gov
Adverse events21
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 | Pneumonia | Infections and infestations | Mini-haplo BMT | 11 | 210 | 11 |
| serious | Atrial fibrillation | Cardiac disorders | Mini-haplo BMT | 1 | 210 | 1 |
| serious | Acute kidney injury | Renal and urinary disorders | Mini-haplo BMT | 2 | 210 | 2 |
| serious | Altered mental status | Nervous system disorders | Mini-haplo BMT | 1 | 210 | 1 |
| serious | Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Mini-haplo BMT | 1 | 210 | 1 |
| serious | Ascites | Gastrointestinal disorders | Mini-haplo BMT | 1 | 210 | 1 |
| serious | Cholestasis | Gastrointestinal disorders | Mini-haplo BMT | 1 | 210 | 1 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Mini-haplo BMT | 1 | 210 | 1 |
| serious | Fungemia | Infections and infestations | Mini-haplo BMT | 3 | 210 | 3 |
| serious | GI bleed | Gastrointestinal disorders | Mini-haplo BMT | 2 | 210 | 2 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mini-haplo BMT | ||
| Total, other adverse events | Mini-haplo BMT | 11 | 210 |
| Total, serious adverse events | Mini-haplo BMT | 20 | 210 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA006973 | Regional Oncology Research Center | NELSON, WILLIAM GEORGE | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| P01CA015396 | Bone Marrow Transplantation in Human Disease | JONES, RICHARD J | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2016 | NIH RePORTER |
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/NCT00134004
GET https://conductscience.org/api/trials/v1/NCT00134004/events?page=2