Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies (PTBCy)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    50
  • sponsor
    St. Petersburg State Pavlov Medical University
Updated on 19 April 2022
chronic myeloid leukemia
myeloid leukemia
blast crisis
cyclophosphamide
hla-a
myelodysplastic syndromes
cell transplantation
leukemia
blast cells

Summary

Prognosis of patients undergoing salvage allogeneic stem cell transplantation for refractory leukemia or other refractory myeloid malignanies is poor. One of the approaches to augment graft-versus-leukemia effect the use of post-transplantation bendamustine in graft-versus-host disease prophylaxis. Despite high frequency of responses and durable remissions after this approach majority of patients develop a serious complication - cytokine release syndrome, which can be life-threatening in some patients. On the other hand post-transplantation cyclophocphamide was reported to abort cytokine release syndrome that sometimes occurs after graft transfusion in patients after haploidentical graft transfusion. The aim of this study is to evaluate if the combination of post-transplantation bendamustine (PTB) and post-transplantation cyclophosphamide (PTCY) facilitates comparable graft-versus leukemia effect to PTB, but with better safety profile and reduced incidence of severe cytokine release syndrome.

Details
Condition Myeloid Leukemia, Acute, Chronic Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm
Treatment bendamustine hydrochloride, Cyclophosphamid
Clinical Study IdentifierNCT04943757
SponsorSt. Petersburg State Pavlov Medical University
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with indication for allogeneic hematopoietic stem cell transplantation
Patients with 5-10/10 HLA-matched related or unrelated 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
Diagnosis
Acute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes
Myeloprolipherative neoplasms
Salvage hematopoietic stem cell transplantation defined as
Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction
No severe concurrent illness
therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: >10% of
blasts despite previous therapy with -7 or complex karyotype, or p53 mutation Chronic
myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines
of TKIs Myeloprolipherative neoplasms : high tumor burden despite previous therapy
including >20 000 WBC/ ul or splenomegaly >15 cm

Exclusion Criteria

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
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
Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper
Somatic or psychiatric disorder making the patient unable to sign informed consent
normal limits, creatinine >2 upper normal limits
Clear my responses

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