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Cyclophosphamide - ClinicalTrials.gov

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Last Updated: 27 June 2022

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Blood Samples to Identify Biomarkers for Post-Transplant Cyclophosphamide

Determine whether endogenous metabolomics compounds obtained before cyclophosphamide therapy can determine the ratio of 4hydroxycyclophosphamide to the cyclophosphamide zone under the curve. To determine mathematical models of CY and mycophenolic acid pharmacokinetics, as well as quantitative models based on these pharmacokinetics, omics results, and clinical findings, the authors are trying to validate mathematical models of CY and mycophenolic acid pharmacokinetics, -omics results, and clinical findings. To investigate the connection between the intestinal microbiome and the plasma metabolome, acute GVHD, and other clinical studies, we need to investigate the connection of the intestinal microbiome with the plasma metabolome, acute GVHD, and other clinical findings. To determine if donors' metabolomics are related to acute GVHD and other medical conditions, visit donor blood samples at one time pre-transplant and see if donors' metabolomics are related to acute GVHD and other clinical outcomes. On day 0, day 3-7, and day 21, patients undergo blood donation prior to transplantation. Prior to transplantation and stool collection before and after transplantation, patients also undergo saliva testing prior to and post-transplant. Patients take blood before and after transplantation, as well as on days 0, 3, and 4. ARM II : Patients receive blood prior to transplantation, as well as on days 0, 3, and 4.

Source link: https://clinicaltrials.gov/ct2/show/NCT04160390


A Phase I Study of ABT-888 in Combination With Cyclophosphamide in Solid Tumors or Non-Hodgkin Lymphoma

When used in combination, using historical single-agent cyclophosphamide and 4-OH results, Evaluate any influence of ABT-888 on the systemic clearance of parent cyclophosphamide and the dose normalized area under the curve of 4-hydroxy cyclophosphamide and the dose normalized area under the curve. PBMC samples for PAR analysis will not be obtained from patients enrolled after 2/15/2012; Evaluate the likelihood of polymerase inhibition in baseline and on-study peripheral blood mononuclear cells samples; on-study and on-study peripheral blood mononuclear cells samples. With ABT-888's combination of cyclophosphamide and doxorubicin, experts evaluate the point of maximum deoxyribonucleic acid damage from a combination of cyclophosphamide and doxorubicin. On day 3, patients receive veliparib orally every 12 hours on days 1-4 and cyclophosphamide intravenously over 60 minutes, according to GROUP I. Patients receive veliparib orally every 12 hours on days 1-4 and cyclophosphamide intravenously over 60 minutes.

Source link: https://clinicaltrials.gov/ct2/show/NCT00740805


Phase I Trial of Low-Dose Cyclophosphamide in Combination With Veliparib (ABT-888) in HER2/Neu-Negative Metastatic Breast Cancer

To determine the appropriate phase II dose of veliparib that can be combined with metronomic dose cyclophosphamide in patients with metastatic breast cancer, consult the following link. With veliparib plus cyclophosphamide, it's easy to determine whether the macroH2A1. 1 and polymerase 1 expression status in archived paraffin embedded tumor samples from either the primary tumor or metastatic disease is predictive of clinical benefit.

Source link: https://clinicaltrials.gov/ct2/show/NCT01351909


Brentuximab Vedotin With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP) for the Treatment of Adult T-Cell Leukemia/Lymphoma: A Pilot Study of the Rare Lymphoma Working Group

To determine how long response to BV-CHEP in patients with adult T-cell leukemia/lymphoma who did or did not receive BV-CHEP care. To determine the overall survival of patients with adult T-cell leukemia/lymphoma treated with BV-CHEP who received or did not receive BV maintenance therapy, it is important to determine whether or not they received or did not receive BV maintenance therapy. Participants can continue taking BV-CHEP for two more cycles cycle 3 and 4, regardless of whether the scan revealed the cancer has remained the same or increased. If, at any time during research, a participant's disease gets worse, the participant will stop study administration and other treatment options will be discussed with you. If the participant is not eligible for a bone marrow transplant and the cancer has remained stable or increased, the participant can continue on BV-CHEP for two more cycles 5 and 6. If a participant is not eligible for a bone marrow transplant and his/her cancer cells did not test positive for CD30, the patient will stop receiving study assistance. With the participant, the researcher will discuss other treatment options that are not part of the study. Participants may continue on brentuximab vedotin alone as maintenance therapy if: they are not eligible for a bone marrow transplant, their cancer cells are positive for CD30, and their cancer has not gotten worse after taking BV-CHEP. If participants' cancer makes it worse, they will be barred from BV maintenance therapy. Participants may continue on BV-CHEP alone as preventative therapy after six cycles of BV-CHEP, if they meet the requirements set out above.

Source link: https://clinicaltrials.gov/ct2/show/NCT03264131


Haploidentical Transplant for Patients With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide

Both related and unrelated, Leukocyte antigen matched donors have been proven curative for patients with various immunodeficiencies, including those with ongoing infections. A haploidentical donor is a related donor with more than 1 HLA antigen mismatch for this protocol. We recommend using a reduced intensity novel conditioning regimen with alemtuzumab, targeted busulfan, and low dose total body irradiation followed by post-transplant cyclophosphamide for patients with chronic granulomatous disease in patients with chronic granulomatous disease in patients with chronic granulomatous disease with no known donor, but their circumstances necessitate a potentially curative, albeit high risk therapy modality. Patients with CGD have elevated risk of Crohn s Disease-like inflammatory bowel disease, mainly colitis, where uncontrolled severe IBD may raise the risk of GvHD. For this reason, the first ten patients accepted will exclude those with intestinal inflammation in the acute category. Patients will be enrolled sequentially as part of the study design.

Source link: https://clinicaltrials.gov/ct2/show/NCT03910452


A Phase I Study of Reduced Intensity Conditioning Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide for Refractory Systemic Sclerosis

The aim of this study is to determine if the drug cyclophosphamide given after bone marrow transplantation is safe and effective in patients with systemic sclerosis that have not responded to other common therapies. Systemic sclerosis is a systemic autoimmune disease characterized by high morbidity and mortality, with an estimated prevalence of 50-300 per year and a prevalence of 2. 3-22. 9 percent million people/year. Disease modification does not require complete engraftment in these patients. The morbidity GVHD for these patients in the allogeneic setting is also unknown, as well as a potentially small number of available donors. Given that there are indications of refractory systemic sclerosis in immunosuppressive therapy in some way, eligible patients will be expected to have experience disease progression despite at least one course of immunosuppressive therapy. recipient patients will be given two doses of the intravenous chemotherapy cyclophosphamide and two oral medications after the transplant to help with graft versus host disease and bone marrow transplantation. A year after the transplant, a chimerism assay that determines how much blood comes from donor cells and how much of the recipient's blood will be drawn from the recipient will be performed at four weeks, eight weeks, six months. If a recipient is eligible, the research program will begin about 30 days before bone marrow transplantation, and participation will persist for up to one year after transplantation.

Source link: https://clinicaltrials.gov/ct2/show/NCT05298358


Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies

Frailty is a phenotype that predicts a patient's intolerance of physiologic stressors and may indicate a patient's tolerance of aggressive consolidative tactics. The dose of PTCy used was partially extrapolated from murine major histocompatibility complex-matched skin allografting strategies and was partly empirical, when clinically translated. On days +3 and +4 in terms of GVHD severity and mortality, both MHC-haploidentical and MHC-disparate murine HCT models were more effective than 50 mg/kg/day. Following PTCy and lower toxicity than higher dosing, lower dosing was also associated with less broad reductions of T-cell numbers. Without an increase in acute GVHD, patients on an NIH study using myeloablative conditioning have increased engraftment and possibly improved immune function. Objectives: Determine whether PTCy 25 mg/kg on days +3 and +4 will provide adequate safeguard against grade III-IV acute GVHD and minimize toxicity associated with transplantation in older and/or unfit transplant recipients receiving reduced intensity conditioned allogeneic HCT. As the dose-limiting toxicities for the Simon two-stage model show that the subjects will be tested for the development of grade III-IV acute GVHD on day +60. PTCy escalation would be allowed in each arm if stopping rules are followed at the 25 mg/kg/day dose on days +3 and +4 doses.

Source link: https://clinicaltrials.gov/ct2/show/NCT04959175


Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

Combined haplo-cord transplantation has recently been shown to be a viable transplant option for those patients in need of an HLA matched donor. We have used this technique in 29 patients with SAA and SAA-changing to MDS, with 27/29 patients having maintained engraftment and achieving transfusion independence in our ongoing protocol 08-H-0046. The advantage over cord transplantation of immediate allograft availability, higher stem cell doses, and the possibility of repeating cell collection is available for collecting CD34+ cells for stem cell boosts or lymphocytes to treat or prevent disease progression or infection. The use of post-transplant cyclophosphamide has been shown to be a safe way to prevent GVHD in recipients of haploidentical HSCT, but the majority of studies have concentrated on patients with hematological malignancies. At present, no studies exist on the use of haploidentical transplantation for patients with ATG-refractory anemia, are heavily transfused and HLA-imunized, although some are not. Patients with SAA,SAA evolving to MDS, or PNH who do not have access to a high quality umbilical cord product that meets NHLBI protocol number 17-H-0091, are therefore expected to investigate the safety and effectiveness of using unmanipulated GCSF mobilized stem cell allograft from a haploidentical donor and post-transplant cyclophosphamide for patients with SAA,SAA evolving to MDS, or PNH that has been graft he advancing to MDS, or PNH who have a good quality umbilical cordograft a cyclograft hepatit cyclograft compliesa cyclo a cyclograft from cyclograft from graft from cyclograft from cyclograft from cyclograft from cyclograft from cyclograft from cyclograft from cyclograft from unmanipulated donor and cyclograft from ograft from.

Source link: https://clinicaltrials.gov/ct2/show/NCT03520647


Phase I/II Study De-intensifying Exposure of Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HLA-haploidentical Hematopoietic Cell Transplantation for Hematologic Malignancies

Following the completion of the phase II portion of the trial that found grade III-IV acute GVHD on day +3 and +4 days+3 days averaging a rate of acute GVHD with reduced PTCy exposure in day +60 and maximum GVHD with reduced dose IV.

Source link: https://clinicaltrials.gov/ct2/show/NCT03983850


A Phase 2 Study of Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients With CD30-Positive Peripheral T-Cell Lymphomas

Determine the anti-lymphoma activity of CHEP-BV as induction therapy in patients with CD30-positive PTCL. Describe the outcomes of CD30-positive PTCL patients who go on to receive BV consolidation therapy post CHEP-BV induction with/without autologous hematopoietic cell transplantation/radiation. In a CD30-positive PTCL, explore the incidence of minimal residual disease negativity and MRD kinetics after CHEP-BV and BV consolidation therapy. As determined in PTCL tumor samples, explore the potential relationship between the result after study and CD30 expression, gene expression profiles, and genetic mutations as shown. On day 1, patients are also receiving brentuximab vedotin IV for over 30 minutes. Patients with objective response are treated to brentuximab vedotin IV over 30 minutes on day 1 between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 - erectin IV therapy, or after completing induction cycle 6.

Source link: https://clinicaltrials.gov/ct2/show/NCT03113500

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions