NCT04943757CompletedPhase 2
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)
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 21 Jun 2021
- Start date
- 21 Jan 2021
- Primary completion date
- 30 May 2024
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Diseases
- Myeloproliferative neoplasms, Chronic myeloid leukaemia, Myelodysplastic syndromes, Acute myeloid leukemia
- NCT number
- NCT04943757
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 50
- From 21 Jan 2021 to the primary completion date, 30 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Somatic or psychiatric disorder making the patient unable to sign informed consent
Lab values
- Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
- 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
Other
- Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
- Respiratory distress \>grade I
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index \<30%
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RM Gorbacheva Research Institute Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.