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Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Graft-versus-host Disease Prophylaxis With Combination of Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies (PTBCy)

NCT04943757•St. Petersburg State Pavlov Medical University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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 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
•No severe concurrent illness

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
•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

Locations (1)

RM Gorbacheva Research Institute

Saint Petersburg, Russia

Key Dates

Start Date

January 21, 2021

Primary Completion Date

May 30, 2024

Completion Date

May 30, 2024

Last Updated

October 15, 2024

Enrollment

ACTUAL participants

Conditions

Myeloid Leukemia, AcuteChronic Myeloid LeukemiaMyelodysplastic SyndromesMyeloproliferative Neoplasm

Interventions

Bendamustine Hydrochloride

DRUG

Cyclophosphamid

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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