Trial · NCT00453388

Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Fanconi Anemia

NCT00453388, Phase 2, Completed, Fred Hutchinson Cancer Center; results first posted 2017-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Fanconi Anemia. Trials, record NCT00453388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00453388

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Fanconi Anemia
NCT number: NCT00453388
Status: Completed
Phases: Phase 2
Enrollment: 6 participants, actual
Lead sponsor: Fred Hutchinson Cancer Center
Conditions: Acute Myeloid Leukemia in Remission, de Novo Myelodysplastic Syndrome, Fanconi Anemia, Previously Treated Myelodysplastic Syndrome
Interventions: Allogeneic Bone Marrow Transplantation, Cyclophosphamide, Cyclosporine, Fludarabine Phosphate, Laboratory Biomarker Analysis, Mycophenolate Mofetil, Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation, Total-Body Irradiation
First posted: 2007-03-28
Last updated: 2020-01-29
Results first posted: 2017-05-24

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 Patients Who Engraft at Each Dose of TBI Used	Up to Day 200	Number of subjects who engrafted. Engraftment defined as greater than 95% donor chimerism.
Primary	Incidence of Grades III-IV Acute GVHD	Up to Day 100	Number of subjects who developed maximum grade acute graft-vs-host disease aGVHD Stages Skin: 1. \- a maculopapular eruption involving \< 25% BSA 2. \- a maculopapular eruption involving 25 - 50% BSA 3. \- generalized erythroderma 4. \- generalized erythroderma with bullous formation and often with desquamation Liver: 1. \- bilirubin 2.0 - 3.0 mg/100 mL 2. \- bilirubin 3 - 5.9 mg/100 mL 3. \- bilirubin 6 - 14.9 mg/100 mL 4. \- bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
Secondary	Incidence of Transplant-related Mortality	Up to Day 200	Number of subjects who expired due to transplant-related mortality
Secondary	Incidence of Adverse Events	Up to Day 100	Number of subjects who developed reportable AEs, assessed using adapted version of the Common Toxicity Criteria

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 Patients Who Engraft at Each Dose of TBI Used	Up to Day 200	No subjects meeting the criteria for Arms I or IV were enrolled.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Incidence of Grades III-IV Acute GVHD	Up to Day 100	No subjects meeting the criteria for Arms I or IV were enrolled.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Transplant-related Mortality	Up to Day 200	No subjects meeting the criteria for Arms I or IV were enrolled.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Adverse Events	Up to Day 100	No subjects meeting the criteria for Arms I or IV were enrolled.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Patients Who Engraft at Each Dose of TBI Used	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	5	Participants
Number of Patients Who Engraft at Each Dose of TBI Used	Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	1	Participants
Incidence of Grades III-IV Acute GVHD	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	1	Participants
Incidence of Grades III-IV Acute GVHD	Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	Participants
Incidence of Transplant-related Mortality	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	1	Participants
Incidence of Transplant-related Mortality	Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	Participants
Incidence of Adverse Events	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	3	Participants
Incidence of Adverse Events	Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0
Overall Study	STARTED	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	5
Overall Study	STARTED	Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	1
Overall Study	STARTED	Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	0
Overall Study	COMPLETED	Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0
Overall Study	COMPLETED	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	5
Overall Study	COMPLETED	Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	1
Overall Study	COMPLETED	Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	0
Overall Study	NOT COMPLETED	Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0
Overall Study	NOT COMPLETED	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events28

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	Mucositis	Gastrointestinal disorders	Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	0	0
other	Mucositis	Gastrointestinal disorders	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	2	5	2
other	Mucositis	Gastrointestinal disorders	Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	1	0
other	Mucositis	Gastrointestinal disorders	Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	0	0
other	elevated bilitrubin	Hepatobiliary disorders	Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	0	0
other	elevated bilitrubin	Hepatobiliary disorders	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	2	5	3
other	elevated bilitrubin	Hepatobiliary disorders	Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	1	0
other	elevated bilitrubin	Hepatobiliary disorders	Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	0	0	0
other	pulmonary hemorrage	Respiratory, thoracic and mediastinal disorders	Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	0	0
other	pulmonary hemorrage	Respiratory, thoracic and mediastinal disorders	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	1	5	1

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	0
Total, all-cause mortality	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	2	5
Total, all-cause mortality	Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	1
Total, all-cause mortality	Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	0	0
Total, other adverse events	Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	0
Total, other adverse events	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	3	5
Total, other adverse events	Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	1
Total, other adverse events	Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	0	0
Total, serious adverse events	Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)	0	0
Total, serious adverse events	Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)	2	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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
P30CA015704	Cancer Center Support Grant	LYNCH, THOMAS JAMES	FRED HUTCHINSON CANCER CENTER	NATIONAL CANCER INSTITUTE	1985 to 2025

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00453388

GET https://conductscience.org/api/trials/v1/NCT00453388/events?page=2

API reference For AI assistants