A Phase I Study of Bendamustine and Melphalan Conditioning and Autologous Stem Cell Transplantation for Treatment of Multiple Myeloma and Relapsed/Refractory B-cell Lymphoma in Elderly Patients
This phase 1 recruiting study is testing to see how multiple chemotherapy drugs along with an autologous stem cell transplant can work together to treat lymphoma with fewer side effects compared to the standard treatment. The chemotherapeutic drugs used are rituximab, bendamustine, and melphalan. These drugs work in different ways to kill cancer cells. The treatment is a single group of people receiving the same amount of medication. The first seven days are of rituximab, followed by bendamustine for two days, then melphalan for one day. Finally, each patient will receive a reinfusion of autologous stem cells on the last day. The researchers want to measure dose toxicities and if they are considerably lower compared to standard treatment.
Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Another recruiting study in phase 2 wants to see if using plerixafor (an immunostimulant that mobilizes stem cells) along with certain chemotherapy drugs and an autologous stem cell transplant will treat lymphoma in patients significantly better than standard treatment. The patients are first treated with the plerixafor to get a mobilized cell count of >6×10^6 CD34+ cells/kg. CD34+ is used as a marker for the number of hematopoietic progenitor cells and are going to be used for the transplant. If patients don’t reach a certain number of CD34+ cells, they are not eligible for the trial. Patients who are eligible are then split into 2 groups that receive separate doses of stem cell therapy; either 3-4×10^6 or 6-8×10^6 of CD34+ cells/kg. Before the stem cell transplant, patients are first given different doses of chemotherapeutic drugs for 6 days. The researchers aim to measure progression of survival and the impact on the CD34+ cell dose for lymphocyte recovery.
Chemotherapy plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin’s Lymphomas
This completed study in phase 2 tests to determine how many stem cells can be collected in patients after being treated with ofatumumab, a monoclonal antibody made in labs to mimic the effects of the immune system, along with chemotherapeutic drugs and G-CSF (granulocyte colony-stimulating factor) which stimulates the production of white blood cells. The treatment begins with ofatumumab given followed by certain chemotherapeutic drugs given on certain times. Two weeks after, blood stem cells are collected. The researchers’ goal is to evaluate side-effects, number of stem cells collected, and how many procedures it takes to collect enough stem cells. The goal of collecting 2×10^6 CD34+ stem cells/kg from each patient was achieved with none to little adverse effects after, proving the treatment worked.
Two Different Methods of Collecting Stem Cells for an Autologous Stem Cell Transplant in Treating Patients with Diffuse Large Cell Lymphoma
Another completed phase 3 study has the same objective of collecting stem cells for an autologous transplant. The researchers state that it is not yet known which method of stem cell collection is best for patients receiving an autologous stem cell transplant. The primary objective is to compare the absolute lymphocyte count they’ll obtain from a “instrument-driven lymphocyte enrichment” autograft to a lymphocyte count on a standard autograft. The researchers also aim to compare effector cells (various “attack” cells of the immune system) on the two autografts as well as determine the survival of patients between the two method arms. Prior to procedure, all patients receive granulocyte-colony stimulating factors (G-CSF) to mobilize lymphocytes. Patients are then either undergoing an immunological autograft where lymphocyte amplification happens or receive a standard autograft collect. Both sets of samples are analyzed for immune function against diffuse large cell lymphoma. Stem cells are then transplanted into patients where the researchers will follow each patient for progression. The criteria for this study include capable mobilization of stem cells and capability to collect sufficient number of CD34 cells. The researchers placed a 95% confidence interval on the one-year overall survival rate which showed that 91.1% of patients in the immunologic autograft arm and 83.6% of the standard arm had survived with the disease for over a year. None of the patients received any adverse effects from the treatment.
Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin’s Lymphoma
The researchers of this trial form a treatment consisting Yttrium-90, a radioactive atom, and Daclizumab, a drug that detects certain markers on Hodgkin’s Lymphoma cells, along with an autologous stem cell transplant. The researchers aim to see if this therapy is more effective than chemotherapy alone. Patients are first given medications to mobilize stem cells to be collected. A month later, patients are then treated with the 90Y and Daclizumab. Patients receive a second dose 6 weeks later. Patients are given a dose of previously collected stem cells. The results show that of 6 participants, 2 had a complete positive response and 2 had a partial positive response to treatment evaluated 100 days after treatment. Also of the 6 participants, 4 had a median number of 36 months disease free after treatment with a range of 30-42. No patient had any serious adverse event. These results show this can be a promising treatment if more trials are done with a greater number of participants.
Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas
The researchers in this phase 2 recruiting study look into using chemotherapeutic drugs busulfan plus fludarabine along with stem cell transplantation from a healthy donor to treat patients with relapsed or refractory T-cell lymphoma. The primary objective of this study is to measure the 2-year progression-free survival of the patients.
High Dose Chemotherapy and Stem Cell Transplant for Non-Hodgkin’s Lymphoma or Central Nervous System (CNS) Lymphoma
The researchers of this phase 2 completed trial state that past studies of autologous stem cell transplantation in combination with the chemotherapy drugs thiotepa, busulfan and cyclophosphamide have shown improvement for patients with lymphoma. The researchers wanted to investigate how adding rituximab to the regimen will differ in improvement for the patients, hoping it will help mobilize stem cells better. The patients will receive the drugs 9 days out before undergoing leukapheresis. More chemotherapy is administered after until 30 days later the stem cells are transplanted back into the patients via IV in the arm. The results show that 81% of patients were progression-free for two years. The response rate for those that have achieved complete remission was at 100%. About 20% of the participants did have some serious adverse effects.
The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
In this recruiting study, researchers are looking to see the impact of autologous stem cell transplantations on patients in the first remission of peripheral T-cell lymphoma. Patients will be given high dose chemotherapy followed by stem cell transplantation as consolidation therapy. The main criteria for patients in this study is achieving CR or PR which are classification categories for treatment on cancer patients. This study is expected to be completed in 2025.
Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas
This recruiting study uses Duvelisib, a small molecule inhibitor known for reducing cellular proliferation for certain immune cells. Researchers for this study aim to see if maintaining this drug in patients after chemotherapy treatment (the BEAM regimen) and an autologous stem cell transplantation will be safe and well tolerated. Patients will initially be given the BEAM regimen of chemotherapy drugs consisting of carmustine, etoposide, cytarabine, and melphalan. Once the stem cells are mobilized the patients will undergo an autologous stem cell transplantation. After 30 of the transplantation the patients will start taking duvelisib for up to year until patients have negative PET CT scans. The researchers are looking to measure the progression free survival after stem cell transplantation for up to two years. The study takes place in Washington state and is expected to end in 2025.
Ixazomib & Rituximab After Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma in Remission
An active study conducted by Emory University aims to figure out the best dose to give of ixazomib citrate, a proteasome inhibitor used to stop unwanted proteins which lead to disrupted cell signals. This in combination with rituximab, a chemotherapy drug, will be given to patients after undergoing a stem cell transplantation. The treatment will be given every 28 days in 10 courses total. Mantle cell lymphoma is a non-Hodgkin lymphoma characterized by abnormal B-cells that build up in lymph nodes.
Gene Therapy-Treated Stem Cells in Treating Patients Undergoing Stem Cell Transplant for Intermediate-Grade or High-Grade AIDS-Related Lymphoma
This is a completed pilot study looking to access how patients with AIDS-related lymphoma can handle chemotherapy along with stem cell therapy to replace the blood forming cells that had been destroyed. The researchers want to see how using lentivirus-transduced hematopoietic progenitor cells in combination with autologous hematopoietic stem cells will create a better outcome compared to standard treatment. Patients begin with chemotherapy of Carmustine, Etoposide, and Cyclophosphamide in order to mobilize stem cells and kill off any cancer cells. Afterwards, the transplant begins of autologous stem cells along with lentivirus vector progenitor cells and CD34+ cells. The results of this study have not yet been posted.
Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin’s Lymphoma (BMT CTN 0701)
This phase 2 completed trial aims to see if lower doses of chemotherapy along with blood stem cell transfusion from a related donor can work to treat Non-Hodgkin’s Lymphoma. Patients undergo nonmyeloablative transplant which allows for a reduced dose of chemotherapy to be used. 2 weeks prior to transplantation is when the chemotherapy starts consisting of fludarabine, cyclophosphamide, and rituximab along with graft vs host disease medication which will continue months after the transplant. The primary outcome of this study is to measure the progression free survival. The results posted indicate that the graft was a success for all patients. About 73% of patients had a progression free survival for up to 2 years.
https://clinicaltrials.gov/ct2/show/results/NCT00912223?id=NCT00912223&draw=2&rank=1&load=cart
Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
This phase 1 recruiting study is divided into 2 cohorts to determine which chemotherapy regimen is best to use before administering a stem cell transplant. Cohort 1 involves using dexamethasone, methotrexate, ifosfamide, pegaspargase, and etoposide; while cohort 2 involves using pralatrexate, brentuximab vedotin, and cyclophosphamide, doxorubicin, and prednisone. Both groups then receive allogenic stem cell therapy. The researchers aim to measure the overall response rate of both groups to compare.
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