Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)

Related Clinical Trial
Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe) HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat First in Human Study of KO-539 in Relapsed or Refractory Acute Myeloid Leukemia Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS Use of T-allo10 in Hematopoietic Stem Cell Transplantation (HSCT) for Blood Disorders Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting A Study of SNDX-5613 in R/R Leukemias Including Those With an MLLr/KMT2A Gene Rearrangement or NPM1 Mutation Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia Management of Mixed-Phenotype Acute Leukemia in the East of France Vincristine, Doxorubicin, And Dexamethasone + Ixazomib in Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

Brief Title

Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)

Official Title

Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)

Brief Summary

      Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning 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 10-20% of graft failures. Fludarabine and busulfan conditioning is the most
      commonly used approach for a variety of disease. Furthermore combination of fludarabine and
      bendamustine was sufficient to facilitate engraftment in patients with chronic lymphocytic
      leukemia and lymphomas. The aim of the study is to evaluate whether addition of bendamustine
      to fladarabine and busulfan conditioning reduces the risk of primary graft failure after
      haploidentical allograft.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

- Incidence of primary and secondary graft failure

Secondary Outcome

 - Incidence of HSCT-associated adverse events (safety and toxicity)

Condition

Leukemia, Acute Lymphoblastic

Intervention

Fludarabine

Study Arms / Comparison Groups

 FluBuBe
Description:  Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days; Days -7 through -6: Bendamustine 130 mg/m2 iv x 2 days; Days -5 through -3: Busulfan 1 mg/kg po qid x 3 days; Days +3 through +4: Cyclophosphamide 50 mg/kg iv x 2 days; Days +5 through +35: Mycophenolate mofetil 45 mg/kg/day, maximum 3 g/day, iv or po x 30 days; Days +5 through +150: Tacrolimus 0.03 mg/kg/day with further correction by concentration

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

January 21, 2021

Completion Date

December 31, 2024

Primary Completion Date

December 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have an indication for allogeneic hematopoietic stem cell
             transplantation with myeloablative conditioning for malignant disease

          -  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

          -  No second malignancies requiring treatment

          -  No severe concurrent illness

        Exclusion Criteria:

          -  Titer of anti-HLA antibodies ≥ 5000 at the time of inclusion

          -  Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50%

          -  Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted

          -  Respiratory distress >grade I

          -  Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper
             normal limits, creatinine >2 upper normal limits

          -  Creatinine clearance < 60 mL/min

          -  Uncontrolled bacterial or fungal infection at the time of enrollment

          -  Requirement for vasopressor support at the time of enrollment

          -  Karnofsky index <30%

          -  Pregnancy

          -  Somatic or psychiatric disorder making the patient unable to sign informed consent
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, +79217961951, [email protected]

Location Countries

Russian Federation

Location Countries

Russian Federation

Administrative Informations


NCT ID

NCT04942730

Organization ID

06/21-n


Responsible Party

Principal Investigator

Study Sponsor

St. Petersburg State Pavlov Medical University


Study Sponsor

, , 


Verification Date

June 2021