Reduced Intensity Conditioning Allogeneic Hematopoietic Stem Cell Transplant (HSCT) For Lymphoma
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|ClinicalTrials.gov Identifier: NCT02724904|
Recruitment Status : Withdrawn (Drug logistics)
First Posted : March 31, 2016
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Procedure: Allogeneic stem cell transplantation Drug: Fludarabine Drug: Thiotepa Drug: Methotrexate||Phase 1 Phase 2|
This research study is a Pilot Study, which is the first time investigators are examining this study intervention (allogeneic stem cell transplantation) for this population (patients with CNS lymphoma), which is a type of stem cell transplantation.
Historically, patients with central nervous system (CNS) involvement by non-Hodgkin lymphoma (NHL) have had high rates of disease relapse after initial therapy. Given these poor outcomes with conventional chemotherapy, more intense treatment with high-dose chemotherapy and autologous stem cell transplantation (ASCT) has been explored, yet relapse remains an issue. For older patients, ASCT may not be feasible given the inability to tolerate high-doses of chemotherapy.
In patients with systemic NHL who relapse after ASCT or cannot tolerate ASCT, yet are responsive to chemotherapy, allogeneic stem cell transplant is often considered. Allogeneic transplantation is thought to work by giving the recipient an entirely new blood system from a donor. This new blood system includes a new immune system which can hopefully attack any lymphoma much like it would attack a bacterial or viral infection. Currently, this is one established standard of care for patients with lymphoma of the body who relapse after initial chemotherapy treatment. The investigators are testing if this treatment can be extended to patients with lymphoma of the central nervous system.
The following chemotherapy drugs included in this study which will be administered: Fludarabine, Thiotepa, and Methotrexate. The FDA (the U.S. Food and Drug Administration) has approved these chemotherapy agents individually as a treatment option for your disease. The combination has not been approved by the FDA. Thiotepa and Methotrexate have been shown to pass through the blood-brain barrier, a highly selective barrier that restricts many chemicals from entering the brain and spinal cord. Fludarabine is the backbone chemotherapy in all reduced intensity conditioning regimens.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Reduced Intensity Conditioning Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed CNS Involvement by Lymphoma|
|Estimated Study Start Date :||May 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
Experimental: Allogeneic Stem Cell Transplantation
Patients will undergo reduced intensity conditioning (fludarabine and thiotepa) followed by fully matched related or unrelated allogeneic stem cell transplantation. Afterwards, patients will receive standard post-transplant care (Methotrexate).
Procedure: Allogeneic stem cell transplantation
Reduced intensity allogeneic stem cell transplantation from a fully matched related or unrelated donor
Other Name: bone marrow transplant
Other Name: Fludara
Other Name: Thioplex
Other Name: Otrexup™
- Treatment-related mortality (TRM) [ Time Frame: From date of transplant to 6 months afterwards ]Death from a non-relapse cause
- Percentage of Participants that experienced grade II-IV acute graft-vs-host disease (GVHD) [ Time Frame: From date of transplant to 6 months afterwards ]Cumulative incidence of acute GVHD
- Progression-free survival (PFS) [ Time Frame: From date of transplant to disease progression or death, whichever occurred first, and patients who are alive without disease progression will be censored at last day known alive in the first 2 years after transplant ]Relapse or death
- Overall survival (OS) [ Time Frame: From time of transplant to death, or last day known alive in the first 2 years after transplant ]Death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724904
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Yi-Bin Chen, MD||Massachusetts General Hospital|