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Recruiting NCT06477549

BeFluBu vs FluBuRux Conditioning in Haploidentical HCT

Phase II Interventional Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Biphenotypic Acute Leukemia Lymphoblastic Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bendamustine Hydrochloride, Ruxolitinib.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Biphenotypic Acute Leukemia, Lymphoblastic Lymphoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Trial of Benadamustine Versus Ruxolitinib With Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation

Overview

Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning intensity and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 7-20% of graft failures in different diseases. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of diseases. In two previously completed trials of addition of either bendamustine and ruxolitinib to conditioning we observed low rates of primary graft failure with both approaches. The study is the direct randomized comparisons of these two approaches with the primary aim of reducing composite events of primary graft failure, relapse and non-relapse mortality. The stratas for the study are Disease Risk Index (DRI) and the age of the haploidentical donor (\<35 vs ≥35).

Interventions

  • Drug Bendamustine Hydrochloride
    Days -7 through -6: Bendamustine 90 mg/m2 iv x 2 days
  • Drug Ruxolitinib
    Days -7 through -2: ruxolitinib 5 mg tid per os

Primary outcome measures

  • Event-free survival [Time frame: 2 years]
Secondary outcome measures (9)
  • Cumulative incidence of primary and secondary graft failure [Time frame: 365 days]
  • Incidence of HSCT-associated adverse events (safety and toxicity) [Time frame: 125 days]
  • Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence [Time frame: 100 days]
  • Cumulative incidence of acute GVHD grade II-IV [Time frame: 125 days]
  • Incidence of moderate and severe chronic GVHD [Time frame: 2 years]
  • Non-relapse mortality analysis [Time frame: 2 years]
  • Overall survival analysis [Time frame: 2 years]
  • GVHD-relapse-free survival analysis [Time frame: 2 years]
  • Relapse cumulative incidence analysis [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Patients must have an indication for allogeneic hematopoietic stem cell transplantation with myeloablative conditioning for malignant disease
  • Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, mixed lineage acute leukemia, lymphoblastic lymphoma, chronic myeloid leukemia, myelodysplastic syndromes, myeloprolipherative neoplasm
  • Age ≥18
  • Malignant disease in hematologic response: <5% of clonal blasts in the bone marrow and no clonal blasts in peripheral blood.
  • Patients with 5-9/10 HLA-matched related donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.
  • Peripheral blood stem cells or bone marrow as a graft source

Exclusion criteria

  • Titer of anti-donor anti-HLA antibodies ≥ 5000 at the time of inclusion
  • Moderate or severe cardiac disease: ejection fraction <50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, myocardial infarction within 3 months before inclusion
  • Stroke within 3 months of inclusion, unless related to the underlying malignancy
  • Severe decrease in pulmonary function: FEV1 <50% or DLCO<50% of predicted or respiratory distress or need for oxygen support;
  • Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits
  • Creatinine clearance < 40 mL/min
  • Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP> 70 mg/L
  • Requirement for vasopressor support at the time of enrollment
  • Karnofsky index <70%
  • Pregnancy
  • Somatic or psychiatric disorder making the patient unable to sign informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • RM Gorbacheva Research Institute — Saint Petersburg

Identifiers

NCT: NCT06477549 · 14/24-n

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗