PTCY + uhCG/EGF for Graft-versus-Host Disease Prophylaxis
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Henry Ford Health System
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?So this a Phase I study with primary objective to determine the feasibility and safety of combining post-transplant cyclophosphamide and urinary-derived human chorionic gonadotropin and epidermal growth factor (uhCG/EGF) as graft versus host disease prophylaxis in stem cell transplant with MMUDs Secondary objectives are to determine the incidence acute and chronic GVHD, progression-free survival , and overall survival
Is the drug uhCG/EGF (Pregnyl) a promising treatment for preventing graft-versus-host disease?The research articles focus on the combination of post-transplant cyclophosphamide (PTCy) and anti-thymocyte globulin (ATG) as promising treatments for preventing graft-versus-host disease (GvHD). They do not mention uhCG/EGF (Pregnyl) as a promising treatment for this purpose.24678
What safety data is available for PTCY + uhCG/EGF in GVHD prophylaxis?The safety data for PTCY (post-transplant cyclophosphamide) in combination with ATG (anti-thymocyte globulin) for GVHD prophylaxis is well-documented. Studies show that this combination is effective in reducing the incidence of acute and chronic GVHD in both matched and mismatched unrelated donor settings, as well as in haploidentical transplants. The combination is considered safe, with a lower risk of GVHD and improved survival outcomes compared to using ATG or PTCY alone. However, specific safety data for the combination of PTCY with uhCG/EGF or Pregnyl is not directly addressed in the provided research.25678
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the idea that PTCY + uhCG/EGF for Graft-versus-Host Disease Prophylaxis (also known as: uhCG/EGF, Pregnyl) is an effective treatment?The available research shows that combining post-transplant cyclophosphamide (PTCy) with anti-thymocyte globulin (ATG) can effectively reduce the risk of both acute and chronic graft-versus-host disease (GVHD) in patients undergoing hematopoietic cell transplantation. Specifically, studies suggest that this combination may lead to lower rates of chronic GVHD and improve survival outcomes compared to using ATG alone. Additionally, PTCy has been shown to result in a lower incidence of severe acute GVHD and better long-term disease control compared to ATG in certain transplant settings. These findings indicate that PTCy, when used in combination with ATG, is a promising approach for GVHD prevention.12367
Eligibility Criteria
This trial is for adults aged 18-70 with certain blood cancers needing a stem cell transplant but without matched donors. They must be mostly healthy, with good organ function and performance status. Women of childbearing age need a negative pregnancy test and must use birth control during the study.Inclusion Criteria
My liver function tests are within normal limits and I don't have chronic hepatitis or cirrhosis.
I have a blood cancer and am eligible for a stem cell transplant without a full match.
I can carry out normal activities with minimal symptoms.
I am between 18 and 70 years old.
Exclusion Criteria
My heart's pumping ability is weak, or I have a history of heart failure or heart disease.
I have had uterine fibroids in the past.
I have had seizures in the past.
I do not have any infections that are not responding to treatment.
I have donor-specific antibodies.
I do not have HIV, hepatitis, or cirrhosis.
I have had cancer that responded to hormone therapy.
Treatment Details
The study tests combining post-transplant cyclophosphamide (PTCY) with uhCG/EGF to prevent graft versus host disease after stem cell transplants from mismatched unrelated donors (MMUDs). It aims to assess safety, feasibility, and effects on disease progression and survival rates.
1Treatment groups
Experimental Treatment
Group I: PTCY and uhCG/EGFExperimental Treatment1 Intervention
PTCY for 2 doses on day +3 and +4 after stem cell transplant followed by uhCG/EGF subcutaneously on day +7, +9 and +11 post stem cell transplant
uhCG/EGF is already approved in United States for the following indications:
🇺🇸 Approved in United States as uhCG/EGF for:
- Acute graft-versus-host disease (GVHD)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Henry Ford HospitalDetroit, MI
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Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
References
Pretreatment with anti-thymocyte globulin versus no anti-thymocyte globulin in patients with haematological malignancies undergoing haemopoietic cell transplantation from unrelated donors: a randomised, controlled, open-label, phase 3, multicentre trial. [2017]Pretreatment with anti-thymocyte globulin (ATG) decreases the occurrence of chronic graft-versus-host disease (CGVHD) after haemopoietic cell transplantation from an unrelated donor, but evidence of patient benefit is absent. We did a study to test whether ATG provides patient benefit, particularly in reducing the need for long-term immunosuppressive treatment after transplantation.
Low rates of acute and chronic GVHD with ATG and PTCy in matched and mismatched unrelated donor peripheral blood stem cell transplants. [2019]We evaluated the combination of ATG and PTCy for GVHD prophylaxis in matched and mismatched unrelated PBSCTs for high-risk hematological malignancies.
Posttransplant cyclophosphamide vs antithymocyte globulin in HLA-mismatched unrelated donor transplantation. [2021]The use of anti-thymocyte globulin (ATG) has represented the standard of care in graft-versus-host disease (GVHD) prophylaxis in patients undergoing a mismatched unrelated donor (MMUD) transplant. The safety and feasibility of posttransplant cyclophosphamide (PTCY) in this setting have been reported recently, but no study has compared the outcomes of PTCY vs ATG in 9/10 MMUD transplants. Using the registry data of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation, we performed a matched-pair analysis comparing those 2 strategies in a 9/10 MMUD setting. Ninety-three patients receiving PTCY were matched with 179 patients receiving ATG. A significantly lower incidence of severe acute GVHD was observed with PTCY compared with ATG. Recipients of the former also showed higher leukemia-free survival and GVHD/relapse-free survival (GRFS). When performing a subgroup analysis including patients receiving peripheral blood stem cells, being in complete remission, or receiving the same associated immunosuppressive agents, superiority of PTCY over ATG was confirmed. Similar to the haploidentical setting, use of PTCY is an effective anti-GVHD prophylaxis in the 9/10 MMUD transplant. Use of PTCY may also provide better outcomes in long-term disease control. These results need confirmation in large prospective randomized trials.
Low-dose post-transplant cyclophosphamide and anti-thymocyte globulin as an effective strategy for GVHD prevention in haploidentical patients. [2023]Low-dose post-transplant cyclophosphamide (PTCy) in conjunction with anti-thymocyte globulin (ATG) appears as a potentially effective graft-versus-host disease (GVHD) prevention strategy in haploidentical hematopoietic cell transplant (haplo-HCT). Our study aims to assess the efficacy of this regimen.
Post-transplant cyclophosphamide versus antithymocyte globulin in allogeneic hematopoietic cell transplantation: a meta-analysis. [2021]Graft-versus-host disease (GVHD) prophylaxis based on post-transplant cyclophosphamide (PTCy) or antithymocyte globulin (ATG) is widely used in allogeneic hematopoietic stem cell transplantations (allo-HCT). The differential impacts of PTCy and ATG on transplantation outcomes are not well characterized. Here we report a meta-analysis of PTCy versus ATG in allo-HCT. Ten studies were eligible, and a total of 1871 patients were included. The incidence of II-IV aGVHD, III-IV aGVHD, and NRM were significantly lower in PTCy arm (HR = 0.63, 95% CI 0.45-0.89; HR = 0.35, 95% CI 0.16-0.77; HR = 0.59, 95% CI 0.48-0.73). PTCy was associated with a better OS and PFS (HR = 0.62, 95% CI = 0.53-0.73; HR = 0.76, 95% CI 0.62-0.93). The relapse rate and cGVHD incidence were not significantly different between PTCy and ATG (HR = 0.85, 95% CI 0.68-1.07; HR = 0.65, 95% CI 0.38-1.12). Thus, compared with ATG, PTCy has a better aGVHD control and OS benefit, without increasing relapse risk, which needs further validation in prospective randomized trials.
Time series clustering of T cell subsets dissects heterogeneity in immune reconstitution and clinical outcomes among MUD-HCT patients receiving ATG or PTCy. [2023]Anti-T-lymphocyte globulin (ATG) or post-transplant cyclophosphamide (PTCy) prevent graft-versus-host disease (GVHD) after hematopoietic cell transplantation (HCT), yet individual patients benefit differentially.
Combining post-transplant cyclophosphamide with antithymocyte globulin for graft-versus-host disease prophylaxis in hematological malignancies. [2023]In search of an ideal partner or alternative to conventional immunosuppressive agents, rabbit anti-thymocyte globulin (ATG) and, more recently, post-transplant cyclophosphamide (PT-Cy) have both emerged as valid and efficient options for preventing graft-versus-host disease (GvHD). To further reduce the risk of GvHD, strategies combining ATG and PT-Cy have recently been investigated. In a haploidentical setting, retrospective studies suggest that combining PT-Cy and ATG may result in a lower incidence of chronic GvHD without increasing the risks of infection or relapse, when compared to PT-Cy without ATG. In haploidentical or unrelated donor settings, adding reduced doses of PT-Cy to ATG may reduce the risk of acute and chronic GvHD and improve survival, particularly GvHD-free, relapse-free survival (GRFS), when compared to ATG without PT-Cy. Overall, the combination of PT-Cy and ATG is a safe and promising approach for patients with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
Low-dose anti-thymocyte globulin plus low-dose post-transplant cyclophosphamide-based regimen for prevention of graft-versus-host disease after haploidentical peripheral blood stem cell transplants: a large sample, long-term follow-up retrospective study. [2023]The novel low-dose anti-thymocyte (ATG, 5 mg/kg) plus low-dose post-transplant cyclophosphamide (PTCy, 50 mg/kg) (low-dose ATG/PTCy)-based regimen had promising activity for prevention of graft-versus-host disease (GVHD) in haploidentical-peripheral blood stem cell transplantation (haplo-PBSCT), but its impacts on long-term outcomes remain to be defined.