Trial · NCT03333486
Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer
NCT03333486, Phase 2, Terminated, Roswell Park Cancer Institute; results first posted 2024-04-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer. Trials, record NCT03333486. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03333486
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer
- NCT number
- NCT03333486
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, Aplastic Anemia, B-Cell Non-Hodgkin Lymphoma, CD40 Ligand Deficiency, Chronic Granulomatous Disease, Chronic Leukemia in Remission, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Congenital Amegakaryocytic Thrombocytopenia, Congenital Neutropenia, Congenital Pure Red Cell Aplasia, Glanzmann Thrombasthenia, Immunodeficiency Syndrome, Myelodysplastic Syndrome, Myelofibrosis, Myeloproliferative Neoplasm, Paroxysmal Nocturnal Hemoglobinuria, Plasma Cell Myeloma, Polycythemia Vera, Recurrent Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome, Severe Aplastic Anemia, Shwachman-Diamond Syndrome, Sickle Cell Disease, T-Cell Non-Hodgkin Lymphoma, Thalassemia, Waldenstrom Macroglobulinemia, Wiskott-Aldrich Syndrome
- Interventions
- Cyclophosphamide, Fludarabine Phosphate, Laboratory Biomarker Analysis, Peripheral Blood Stem Cell Transplantation, Total-Body Irradiation
- First posted
- 2017-11-07
- Last updated
- 2025-07-04
- Results first posted
- 2024-04-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relapse Rate | At 1 year | The number of participants that relapse within 1 year. |
| Secondary | ANC Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment | At 1 year post-transplant | Absolute Neutrophil Count Engraftment rate was defined as the number of participants that received an engraftment within 1 year post-transplant and ANC \> 0.5x10\^9/L for three consecutive days, out of the total number of participants. The rate was computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. |
| Secondary | Platelet Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment | At 1 year post-transplant | Platelet Engraftment rate was defined as the number of participants that received an engraftment within 1 year post-transplant and the platelets \>= 20 x 10\^9/L after 7 consecutive days with no platelet transfusions, out of the total number of participants. The rate was computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. |
| Secondary | Proportion of Participants With Acute Graft Versus Host Disease (GVHD) | At 100 days post-transplant | Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. |
| Secondary | Proportion of Participants With Chronic Graft Versus Host Disease (GVHD) | At 1 year post-transplant | Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. |
| Secondary | Overall Survival | up to 5 years and 8 months | Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. Will be obtained using the product-limit based Kaplan-Meier method. |
| Secondary | Progression Free Survival | up to 5 years and 8 months | Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. Will be obtained using the product-limit based Kaplan-Meier method. |
| Secondary | Transplant Related Mortality | At 1 year post-transplant | Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. |
| Other | Immune Reconstitution | Up to 1 year | Will be assessed by bone marrow transplantation SOC immunophenotyping panel and by analysis of cytomegalovirus-specific immunity. |
| Other | Lymphoid Chimerism Expressed as a Percentage of Donor Cells | At 30 days | Mean lymphoid chimerism expressed as a percentage of donor cells |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relapse Rate | At 1 year | All treated and eligible patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | ANC Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment | At 1 year post-transplant | All treated and eligible patients | percentage of participants | NUMBER |
| SECONDARY | Platelet Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment | At 1 year post-transplant | All treated and eligible patients | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With Acute Graft Versus Host Disease (GVHD) | At 100 days post-transplant | All treated and eligible patients | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Chronic Graft Versus Host Disease (GVHD) | At 1 year post-transplant | All treated and eligible patients | proportion of participants | NUMBER |
| SECONDARY | Overall Survival | up to 5 years and 8 months | All treated and eligible patients | months | MEDIAN |
| SECONDARY | Progression Free Survival | up to 5 years and 8 months | All treated and eligible patients | months | MEDIAN |
| SECONDARY | Transplant Related Mortality | At 1 year post-transplant | All treated and eligible patients | proportion of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Immune Reconstitution | Up to 1 year | |||
| OTHER_PRE_SPECIFIED | Lymphoid Chimerism Expressed as a Percentage of Donor Cells | At 30 days | All treated and eligible patients. Samples were not obtained at day 100 for 8 subjects. | percentage of donor cells | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relapse Rate | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 14 | Participants | ||
| ANC Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 84 | 95% Confidence Interval 66.0 to 95.0 | percentage of participants | |
| Platelet Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 77 | 95% Confidence Interval 59 to 90 | percentage of participants | |
| Proportion of Participants With Acute Graft Versus Host Disease (GVHD) | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 0.3226 | 95% Confidence Interval 0.1668 to 0.5137 | proportion of participants | |
| Proportion of Participants With Chronic Graft Versus Host Disease (GVHD) | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 0.1935 | 95% Confidence Interval 0.0745 to 0.3747 | proportion of participants | |
| Overall Survival | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 15.7 | 95% Confidence Interval 7.1 to NA | months | |
| Progression Free Survival | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 15.7 | 95% Confidence Interval 5.5 to 49.5 | months | |
| Transplant Related Mortality | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 0.0323 | 95% Confidence Interval 0.0008 to 0.1670 | proportion of participants | |
| Lymphoid Chimerism Expressed as a Percentage of Donor Cells | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 99.85 | Standard Deviation 0.46 | percentage of donor cells | |
| Myeloid Chimerism Expressed as a Percentage of Donor Cells | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 99.93 | Standard Deviation 0.22 | percentage of donor cells |
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 | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 31 | |
| Overall Study | COMPLETED | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 29 | |
| Overall Study | NOT COMPLETED | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 2 |
Source ClinicalTrials.gov
Adverse events95
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 | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 14 | 31 | 15 |
| other | Atrial fibrillation | Cardiac disorders | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 1 | 31 | 1 |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 1 | 31 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 4 | 31 | 4 |
| other | Ascites | Gastrointestinal disorders | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 1 | 31 | 1 |
| other | Colitis | Gastrointestinal disorders | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 1 | 31 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 17 | 31 | 22 |
| other | Dry mouth | Gastrointestinal disorders | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 2 | 31 | 2 |
| other | Fecal incontinence | Gastrointestinal disorders | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 3 | 31 | 3 |
| other | Flatulence | Gastrointestinal disorders | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 1 | 31 | 1 |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 17 | 31 |
| Total, other adverse events | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 27 | 31 |
| Total, serious adverse events | Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT) | 8 | 31 |
Source ClinicalTrials.gov
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 |
|---|---|---|---|---|---|
| P30CA016056 | Roswell Park Cancer Center Support Grant | JOHNSON, CANDACE S | ROSWELL PARK CANCER INSTITUTE CORP | 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.
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/NCT03333486
GET https://conductscience.org/api/trials/v1/NCT03333486/events?page=2