2-Step Stem Cell Transplant for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new process for stem cell transplants to treat blood cancers. It aims to determine if administering chemotherapy and radiation before transplanting donor stem cells and white blood cells in two steps can better control and reduce complications. The trial also examines medications to prevent graft versus host disease, where donor cells attack the patient's body. People with blood cancers who have a suitable donor and meet specific health criteria might be a good fit for this trial.
As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in blood cancer treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you should not have received certain drugs like alemtuzumab or antithymocyte globulin recently. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that treatments used in the 2-step stem cell transplant for blood cancers have varying safety records. The stem cell transplant itself is generally effective, but past studies indicate it can lead to complications like graft versus host disease (GVHD), where donor cells attack the patient's body.
Cyclophosphamide, a chemotherapy drug used in the process, carries serious side effects. It may lower white blood cell counts, increasing infection risk, and there is a possibility of developing other cancers later.
Donor lymphocyte infusion, another part of the treatment, is usually safe, especially when doses increase gradually. This approach helps keep the risk of GVHD low.
Total-body irradiation, used before the transplant, has shown a high survival rate with low radiation-related side effects. However, like any radiation treatment, long-term effects can occur.
These treatments have been studied for many years. While they come with risks, they are also effective in treating blood cancers. Anyone considering joining a trial should discuss these risks with their doctor.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the 2-Step Stem Cell Transplant for blood cancers because it combines several innovative components that could enhance treatment effectiveness. Unlike traditional therapies, this approach involves a two-step process with total-body irradiation and donor lymphocyte infusion before the actual stem cell transplant. This regimen could potentially improve the body's preparation for the transplant and boost the immune response against cancer cells. Additionally, the careful use of drugs like cyclophosphamide and the targeted prevention of graft-versus-host disease with tacrolimus and mycophenolate mofetil might reduce complications and improve patient outcomes. Overall, this method offers a potentially more comprehensive and effective strategy for treating blood cancers compared to standard treatments.
What evidence suggests that this trial's treatments could be effective for blood cancers?
Research has shown that a 2-step stem cell transplant method for blood cancers is promising. In this trial, participants will undergo Allogeneic Hematopoietic Stem Cell Transplantation, which can lead to long-term remission and survival, particularly in younger patients or those whose cancer is in early remission. The trial also includes Donor Lymphocyte Infusion after the transplant, which has improved survival rates. Additionally, participants will receive Total-Body Irradiation as a preparatory treatment before the transplant, which has demonstrated better survival and relapse rates compared to other methods. Together, these treatments aim to effectively target cancer cells while promoting the growth of healthy blood cells.36789
Who Is on the Research Team?
USAMA GERGIS, MD
Principal Investigator
Sidney Kimmel Cancer Center at Thomas Jefferson University
Are You a Good Fit for This Trial?
This trial is for patients with blood cancers who have a heart function of at least 45%, lung capacity over half the expected, normal liver function, and kidney clearance above 60 mL/min. They need a closely matched related donor for stem cell transplant and must not be HIV positive or have another active cancer (except certain skin cancers). Women should use effective contraception, and men should abstain from sex during treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning Regimen
Participants undergo total body irradiation twice daily on days -9 to -6 and receive cyclophosphamide IV on days -3 and -2
Transplant
Participants receive donor lymphocytes IV on day -6 and undergo hematopoietic stem cell transplantation on day 0
GVHD Prophylaxis
Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV BID from day -1 through day 28
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Allogeneic Hematopoietic Stem Cell Transplantation
- Cyclophosphamide
- Donor Lymphocyte Infusion
- Mycophenolate Mofetil
- Tacrolimus
- Total-Body Irradiation
Trial Overview
The study tests a two-step stem cell transplant process to treat blood cancers. It involves chemotherapy, total body irradiation followed by white blood cell and stem cell transplants from donors in controlled doses to help rebuild healthy bone marrow while trying to prevent graft versus host disease using tacrolimus and mycophenolate mofetil.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6. TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI. CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2. TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0. GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Allogeneic Hematopoietic Stem Cell Transplantation is already approved in European Union, United States, Canada, Japan for the following indications:
- Primary immunodeficiency disorders
- Immune dysregulatory disorders
- Hemophagocytic lymphohistiocytosis
- Bone marrow failure syndromes
- Hemoglobinopathies
- Primary immunodeficiency disorders
- Immune dysregulatory disorders
- Hemophagocytic lymphohistiocytosis
- Bone marrow failure syndromes
- Hemoglobinopathies
- Primary immunodeficiency disorders
- Immune dysregulatory disorders
- Hemophagocytic lymphohistiocytosis
- Bone marrow failure syndromes
- Hemoglobinopathies
- Primary immunodeficiency disorders
- Immune dysregulatory disorders
- Hemophagocytic lymphohistiocytosis
- Bone marrow failure syndromes
- Hemoglobinopathies
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Cancer Center at Thomas Jefferson University
Lead Sponsor
Citations
Outcome of Allogeneic Hematopoietic Stem Cell ...
The primary endpoints were overall survival (OS), graft-versus-host disease (GVHD) Relapse-Free Survival (GRFS), Leukemia-Free Survival (LFS) ...
Long-Term Outcomes After Allogeneic Hematopoietic Stem ...
At allo-HSCT, 135 patients (47.7%) exhibited complete remission (CR), 63 (22.3%) partial response, 30 (10.6%) stable disease, and 55 (19.4%) progressing disease ...
Clinical outcomes of allogeneic hematopoietic stem cell ...
This study emphasizes the efficacy of HSCT in the treatment of infant AML, with higher OS rates compared to childhood AML. It also supports UCB as a viable ...
Predictive Factors and Outcomes after Allogeneic Stem ...
Two-thirds (66%) of the patients underwent allo-HSCT in first complete remission (CR1), 28% did so in second or later complete remission (CR2+), ...
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ashpublications.org
ashpublications.org/bloodadvances/article/7/22/7007/498210/Allogeneic-hematopoietic-cell-transplantation-forAllogeneic hematopoietic cell transplantation for blastic ...
Allo-HCT is effective in providing durable remissions and long-term survival in BPDCN. Younger age and allo-HCT in CR1 predicted for improved ...
Safety and efficacy of allogeneic hematopoietic stem cell ...
However, the safety and efficacy of HSCT may be affected by prior PD-1 blockade. We conducted an international retrospective analysis of 39 patients with ...
OUTCOMES OF ALLOGENEIC STEM CELL ...
The aim of this study is to evaluate the allogeneic hematopoietic stem cell transplantation data performed in our transplant center for patients diagnosed ...
Outcomes of Adult T-Cell Leukemia/Lymphoma with ...
We report favorable outcomes, with 8/17 in ongoing remission, 2/17 with prolonged (>6 years) disease-free survival, and a low incidence of transplant-related ...
Long-Term Outcomes After Allogeneic Hematopoietic Stem ...
This retrospective observational study included 285 allogeneic hematopoietic stem cell transplantation (allo-HSCT) procedures, performed between 2000 and 2020.
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