Trial · NCT06477549
BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
NCT06477549, Phase 2, Recruiting, St. Petersburg State Pavlov Medical University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BeFluBu vs FluBuRux Conditioning in Haploidentical HCT. Trials, record NCT06477549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06477549
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
- NCT number
- NCT06477549
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 220 participants, estimated
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Biphenotypic Acute Leukemia, Lymphoblastic Lymphoma, Myeloproliferative Neoplasm, Myelodysplastic Syndromes
- Interventions
- Bendamustine Hydrochloride, Ruxolitinib
- First posted
- 2024-06-27
- Last updated
- 2024-06-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free survival | 2 years | Measure: Kaplan-Meier estimate of either relapse, primary or secondary graft failure or death from all causes |
| Secondary | Cumulative incidence of primary and secondary graft failure | 365 days | Cumulative primary and secondary graft failure, competing risk is death and relapse |
| Secondary | Incidence of HSCT-associated adverse events (safety and toxicity) | 125 days | Toxicity assessment is based on presence of NCI CTC AE 5.0 event grades 3-5. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2020. Transplant-associated microangiopathy incidence assessment is based on Harmonization criteria by Schoettler et al. All toxicity measurements will be aggregated as severity scores |
| Secondary | Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence | 100 days | proportion of patients, requiring systemic treatment for bacterial, viral and fungal disease |
| Secondary | Cumulative incidence of acute GVHD grade II-IV | 125 days | Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure |
| Secondary | Incidence of moderate and severe chronic GVHD | 2 years | Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria, competing risk is death, relapse and primary graft failure |
| Secondary | Non-relapse mortality analysis | 2 years | Cumulative incidence of patients with mortality without hematological relapse of malignancy |
| Secondary | Overall survival analysis | 2 years | Measure: Kaplan-Meier estimate of death from all causes |
| Secondary | GVHD-relapse-free survival analysis | 2 years | Measure: Kaplan-Meier estimate of death, acute GVHD grade III-IV, severe chronic GVHD or relapse |
| Secondary | Relapse cumulative incidence analysis | 2 years | Cumulative incidence of patients with relapse, competing risk is non-relapse mortality |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT06477549
GET https://conductscience.org/api/trials/v1/NCT06477549/registered