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NCT05436418
Background: Blood cancers (such as leukemias or lymphomas) often do not respond to standard treatments. A transplant of blood stem cells from a healthy donor can help people with these cancers. Sometimes these transplants cause serious side effects, including a common immunologic problem called graft-versus-host disease. A drug called cyclophosphamide given early after the transplant (post-transplantation cyclophosphamide, PTCy) can reduce these complications. But sometimes this drug has its own negative effects. Furthermore, studies in mice suggest that an intermediate, rather than very high, dose of this drug may best protect against graft-versus-host disease. Objective: To find out if a lower dose of PTCy is more helpful for people who undergo blood stem cell transplants. Eligibility: People aged 18 and older who have a blood cancer and are eligible for a transplant of blood stem cells from another person. Healthy donors are also needed but must be related to the individual needing the transplant. Design: Participants will undergo screening. Transplant recipients will have imaging scans and tests of their heart and lung function. They will be assessed for the status of their cancer, including bone marrow taken from their pelvis and possibly also scans and/or fluid drawn from the spine depending on the disease type. Donors will be screened for general health. They will give several tubes of blood. They will give an oral swab and saliva and stool samples for research. Recipients will be in the hospital at least 4 to 6 weeks. They will have a temporary catheter inserted into a vein in the chest or neck. Medications will be given and blood will be drawn through the catheter. The transplanted stem cells will be given through the catheter. Participants will receive medications both before and after the transplant. Participants will return to the clinic at least once a week for 3 months after leaving the hospital. Follow-up visits will continue periodically for 5 years.
NCT05153226
Post-transplantation cyclophosphamide (PTCY) has become increasingly popular in the haploidentical HCT setting because it overcomes the HLA-mismatch barrier and levels GVHD risk. This advantage may also prove useful in the context of unrelated donor (UD) transplantation. GVHD prophylaxis for matched unrelated donor hematopoietic cell transplantation (alloHCT) in Europe is mainly conducted with ATG. Still, the burden of acute and chronic GVHD and especially of relapse remains high with both approaches for GVHD prevention. PTCY has not been tested against the current standard ATG for GvHD prophylaxis in large randomized trials. The goal of this trial is to compare the outcomes of PTCY and ATG for patients receiving unrelated donor PBSCT. PTCY-based prophylaxis promises to have beneficial net effects on immune reconstitution, GVHD and disease control, and thus might impact on patient survival.
NCT05075681
The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation.
NCT03993639
Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.
NCT04582604
The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Decitabine intensified Conditioning Regimen in Patients with High Risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.
NCT02398708
The purpose of this study is to examine the gut bacteria, levels of peripheral blood inflammation markers, and symptoms in patients with and without chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). The hypothesis is that individuals with cGVHD will have lower levels of microbial diversity, higher levels of inflammatory metabolites in stool and peripheral measures, and higher levels of symptoms than individuals without cGVHD.
NCT03771222
Unmanipulated allogenic peripheral blood stem cell transplantation (allo-PBSCT) has been an established treatment to cure high-risk leukemia/lymphoma. Relapse is the main cause of treatment failure for patients with relapsed/refractory disease or with very high-risk gene mutations such as TP53, TET2 and DNMT3a. Donor lymphocyte infusion (DLI) is an option to reduce relapse after allo-PBSCT for very high-risk disease without effective targeted therapy. In this study, the investigators aimed to compare the safety and efficacy of prophylactic DLI with G-CSF-primed peripheral blood progenitors for prevention of relapse after allo-PBSCT in patients with very high-risk leukemia/lymphoma.
NCT02326675
Oral mucositis is a common complication of cancer therapy. Mucositis results from damage to the mucosal epithelium after delivery of chemotherapy or radiation treatments designed to treat the cancer. A number of treatment factors have been shown to influence the incidence and severity of mucositis, including chemotherapy type and dosage. High-dose chemotherapy before stem cell transplantation can cause severe oral mucositis and is often the side effect that patients find the most difficult to endure. Cryotherapy, keeping ice chips in the mouth during chemotherapy infusion, has been shown to prevent or alleviate mucositis caused by high-dose melphalan alone or given in combinations used in pre-transplant conditioning. One other drug notorious for causing severe mucositis is etoposide (VP-16). The specific aims of the study are: 1) to assess tolerability of cryotherapy given during chemotherapy administration; 2) to determine the efficacy of cryotherapy in reducing etoposide-induced mucositis.
NCT02848105
aGVHD remains as complication in patients after allogeneic stem cell transplantation. Methylprednisolone at 1\~2mg/kg is considered as standard first-line treatment. In recent lab study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects. In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment may improve the outcome of aGVHD.
NCT01255527
Despite the advantages of autologous stem cell transplantation (ASCT) over conventional chemotherapy,1,2 the results of high-dose chemoradiotherapy in multiple myeloma (MM) are still unsatisfactory with a 6-year event free survival (EFS) of only 24%. Based on existing data, bortezomib-containing regimens are currently accepted at many centers as an induction treatment option for patients with symptomatic MM, particularly if it is planned to offer subsequent high-dose therapy with ASCT. So we will use bortezomib-containing regimens as induction prior to this novel conditioning regimen. The objective of the present study is to compare the toxicity and therapeutic efficacy of a new high-dose regimen using dose-escalation of BOR, BU and MEL for ASCT in the Korean patients with MM. The patients should be treated with bortezomib-containing regimens as an induction therapy before ASCT. We will specifically analyze (i) the efficacy of the conditioning regimen in improving the pre-ASCT status, response rate (ii) engraftment and transplant-related mortality (TRM) and (iii) the impact on survival including progression-free survival (PFS) and overall survival (OS). Triple combination of conditioning will enhance the response rate after ASCT, and will improve not only PFS, but also OS. We think that data from this study may further strengthen feasibility of BOR in conditioning prior to ASCT.