Trial · NCT00796068
Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant
NCT00796068, Phase 2, Completed, Fred Hutchinson Cancer Center; results first posted 2023-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant. Trials, record NCT00796068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00796068
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant
- NCT number
- NCT00796068
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 130 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Myelodysplastic Syndrome (MDS)
- Interventions
- Cyclosporine, Fludarabine Phosphate, Laboratory Biomarker Analysis, Mycophenolate Mofetil, Total-Body Irradiation, Treosulfan, Umbilical Cord Blood Transplantation
- First posted
- 2008-11-24
- Last updated
- 2023-02-17
- Results first posted
- 2023-02-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Graft Failure/Rejection | Up to 100 days | Patients will be considered primary graft failure provided they meet any criteria listed below, in the absence of documented disease persistence/recurrence or active bone marrow infection (ex. Cytomegalovirus (CMV)): i. Absence of 3 consecutive days with neutrophils \>500/u1 combined with host CD3+ peripheral blood chimerism ≥50% at day 42 ii. Absence of 3 consecutive days with neutrophils \>500/u1 under any circumstances at day 55 iii. Death after day 28 with neutrophil count \<100/u1 without any evidence of engraftment (\< 5% donor CD3+) iv. Primary autologous count recovery with \< 5% donor CD3+ peripheral blood chimerism at count recovery and without relapse |
| Primary | Number of Participants With Secondary Graft Failure | Up to 2 years | Secondary graft failure is defined as decline of neutrophil count to \<500/ul with loss of donor chimerism after day 55 |
| Primary | Number of Patients With Non-relapse Mortality (NRM) | At day -200 | Defined as death from any cause without sign of disease progression or relapse. Loss to follow up are censored, whereas disease relapse or progression are considered competing risks. |
| Secondary | Number of Participants Surviving by 1 Year | At 1 year | Overall survival was measured from the first day of CBT infusion until death from any cause. |
| Secondary | The Number of Participants Alive at Two-years Follow up. | Up to 2 years | Overall survival of participants after two-years of follow up. |
| Secondary | Non-relapse Mortality | Up to 2 years | Death of any cause other than relapse or disease progression was considered. |
| Secondary | Duration (Days) Until Participants Obtained Platelet Engraftment | At 6 months | Summarized using a range and median of measure in days until participants reached platelet engraftment. Platelet engraftment was defined as the first of 7 consecutive days when the platelet count exceeded 20 x 109/L (untransfused). |
| Secondary | Number of Participants With Acute Graft-versus-host Disease (GVHD) Grade II-IV by Day 100 | Day 100 | Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. Diagnosing and grading acute GVHD is based on clinical findings (the organ stage, response to treatment and whether GVHD was a major cause of death) and frequently varies between transplant centers and independent reviewers. |
| Secondary | Incidence of Acute or Chronic Graft-versus-host Disease (GVHD) | At 1 year | Overall GVHD is determined based on the organ stage, response to treatment and whether GVHD was a major cause of death. Chronic GVHD will be defined according to the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease. Described as mild, moderate, or severe as graded according to the attached Organ Scoring Sheet. Symptoms consistent with both chronic and acute GVHD occurring after day 100 will be considered overlap chronic GVHD syndrome. |
| Secondary | Incidence of Relapse or Disease Progression | Up to 2 years | Cumulative incidence estimates using non-relapse mortality as competitive event. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Graft Failure/Rejection | Up to 100 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Secondary Graft Failure | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Patients With Non-relapse Mortality (NRM) | At day -200 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Surviving by 1 Year | At 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number of Participants Alive at Two-years Follow up. | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Non-relapse Mortality | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration (Days) Until Participants Obtained Platelet Engraftment | At 6 months | days | MEDIAN | |
| SECONDARY | Number of Participants With Acute Graft-versus-host Disease (GVHD) Grade II-IV by Day 100 | Day 100 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Acute or Chronic Graft-versus-host Disease (GVHD) | At 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Relapse or Disease Progression | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Graft Failure/Rejection | Arm I (Low Risk for Graft Failure) | 2 | Participants | ||
| Number of Participants With Graft Failure/Rejection | Arm II (High Risk for Graft Failure) | 5 | Participants | ||
| Number of Participants With Secondary Graft Failure | Arm I (Low Risk for Graft Failure) | 0 | Participants | ||
| Number of Participants With Secondary Graft Failure | Arm II (High Risk for Graft Failure) | 0 | Participants | ||
| Number of Patients With Non-relapse Mortality (NRM) | Arm I (Low Risk for Graft Failure) | 7 | Participants | ||
| Number of Patients With Non-relapse Mortality (NRM) | Arm II (High Risk for Graft Failure) | 6 | Participants | ||
| Number of Participants Surviving by 1 Year | Arm I (Low Risk for Graft Failure) | 51 | Participants | ||
| Number of Participants Surviving by 1 Year | Arm II (High Risk for Graft Failure) | 47 | Participants | ||
| The Number of Participants Alive at Two-years Follow up. | Arm I (Low Risk for Graft Failure) | 50 | Participants | ||
| The Number of Participants Alive at Two-years Follow up. | Arm II (High Risk for Graft Failure) | 44 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Low Risk for Graft Failure) | 66 | |
| Overall Study | STARTED | Arm II (High Risk for Graft Failure) | 64 | |
| Overall Study | COMPLETED | Arm I (Low Risk for Graft Failure) | 66 | |
| Overall Study | COMPLETED | Arm II (High Risk for Graft Failure) | 64 | |
| Overall Study | NOT COMPLETED | Arm I (Low Risk for Graft Failure) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (High Risk for Graft Failure) | 0 |
Source ClinicalTrials.gov
Adverse events164
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 | Allergic Reaction | Immune system disorders | Arm I (Low Risk for Graft Failure) | 2 | 66 | 2 |
| other | Allergic Reaction | Immune system disorders | Arm II (High Risk for Graft Failure) | 1 | 64 | 1 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm I (Low Risk for Graft Failure) | 1 | 66 | 1 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm II (High Risk for Graft Failure) | 0 | 64 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | Arm I (Low Risk for Graft Failure) | 0 | 66 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | Arm II (High Risk for Graft Failure) | 1 | 64 | 1 |
| other | Atrial Flutter | Cardiac disorders | Arm I (Low Risk for Graft Failure) | 2 | 66 | 2 |
| other | Atrial Flutter | Cardiac disorders | Arm II (High Risk for Graft Failure) | 0 | 64 | |
| other | Sinus tachycardia | Cardiac disorders | Arm I (Low Risk for Graft Failure) | 1 | 66 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Arm II (High Risk for Graft Failure) | 0 | 64 | 0 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Low Risk for Graft Failure) | 16 | 66 |
| Total, all-cause mortality | Arm II (High Risk for Graft Failure) | 20 | 64 |
| Total, other adverse events | Arm I (Low Risk for Graft Failure) | 63 | 66 |
| Total, other adverse events | Arm II (High Risk for Graft Failure) | 59 | 64 |
| Total, serious adverse events | Arm I (Low Risk for Graft Failure) | 27 | 66 |
| Total, serious adverse events | Arm II (High Risk for Graft Failure) | 23 | 64 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32706891 | DERIVED |
Source PubMed
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 comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): Number of Participants With Graft Failure/Rejection | Trial comparisons |
| Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): Number of Participants Surviving by 1 Year | Trial comparisons |
| Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): Number of Patients With Non-relapse Mortality (NRM) | Trial comparisons |
| Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): Number of Participants Surviving up to 2 Years Without Disease Progression | Trial comparisons |
| Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): Non-relapse Mortality | Trial comparisons |
| Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): Incidence of Acute or Chronic Graft-versus-host Disease (GVHD) | Trial comparisons |
| Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): Incidence of Clinically Significant Infections | Trial comparisons |
| Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): Number of Participants With Secondary Graft Failure | Trial comparisons |
| Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): The Number of Participants Alive at Two-years Follow up. | Trial comparisons |
| Arm I (Low Risk for Graft Failure) vs Arm II (High Risk for Graft Failure): deaths from any cause | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
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/NCT00796068
GET https://conductscience.org/api/trials/v1/NCT00796068/results?page=2