Track topics on Twitter Track topics that are important to you
The goal of this clinical research study is to learn about the safety of giving a stem cell transplant from a tissue-mismatched donor, followed by cyclophosphamide, to patients with certain types of blood disorders or blood cancers. Melphalan, thiotepa, and fludarabine will also be given before the transplant.
Researchers will study the heath status of these patients at 3 months after the transplant.
The Study Treatment:
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
In this study, researchers want to learn if cyclophosphamide can help to prevent graft-versus-host disease (GVHD -- when transplanted immune tissue, such as white blood cells, attacks the tissues of the recipient's body).
Melphalan, thiotepa, and fludarabine are commonly used in combination with a stem cell transplant.
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Blood (about 4 tablespoons) and urine will be collected for routine tests.
- You will have a physical exam.
- You will have a lung function test.
- You will have a chest x-ray to check for a lung infection.
- You will have a computed tomography (CT) scan of the sinuses to check for infection.
- You will have an electrocardiogram (ECG--a test to measure the electrical activity of the heart).
- You will have a multi-gated acquisition (MUGA) scan or an echocardiogram (ECHO) to test your heart function.
- You will have a bone marrow biopsy to check the status of the disease. To collect a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
- Women who are able to have children must have a negative blood pregnancy test. This blood will be drawn as part of the routine sample described above.
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
Study Treatment Administration:
- If you are found to be eligible to take part in this study, you will receive chemotherapy for 6 days:
- You will receive melphalan by vein over 30 minutes on Day -8 (8 days before the transplant).
- You will receive thiotepa by vein over 4 hours on Day -7.
- You will receive fludarabine by vein over 1 hour on Days -6, -5, -4, and -3.
On Day 0, you will receive the donor's stem cells by vein. This may last anywhere from 15 minutes to several hours.
On Days 3 and 4, you will receive cyclophosphamide by vein over 3 hours. You will also receive mesna by vein over 30 minutes every 4 hours for a total of 10 mesna doses on Days 3 and 4. Mesna is given to lower the risk of side effects to the bladder.
Starting on Day 5, you will receive tacrolimus and mycophenolate mofetil (MMF) to help lower the risk of GVHD. Tacrolimus will be given by vein as a continuous infusion for about 2 weeks. After the 2 weeks of taking tacrolimus by vein, you will take tacrolimus by mouth as a pill for at least 3 months. MMF will be given by mouth, 3 times a day, usually until Day 35.
Starting on Day 7, you will receive filgrastim (G-CSF) once a day as an injection under the skin, until your blood cell counts reach a high enough level.
Depending on the type of disease that you have, your doctor may decide to give you rituximab by vein over several hours on Days -13, -6, 1, and 8. Rituximab is given to help the body get rid of abnormal white blood cells.
Length of Study Participation:
You will be in the hospital for about 4 weeks after the transplant. You will be taken off study if the disease gets worse. The study drugs will be stopped if intolerable side effects occur.
You will be asked to stay close enough to Houston to be able to come back for any visits for at least 100 days after the transplant.
On the day of the transplant (Day 0), blood (about 4 tablespoons) will be drawn to check your body's ability to fight infection, and for research testing related to the status of the disease.
At 1, 3, 6, and 12 months after the transplant, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests.
- You will have a bone marrow biopsy to check the status of the disease.
- Blood (about 4 tablespoons) will be drawn to measure tumor cells and to predict graft failure and/or relapse.
- You may have urine collected and/or scans performed such as x-rays, CT scans, and/or a positron emission tomography (PET) scan. These scans and urine tests would only be done if the study doctor thinks they are needed to check the status of the disease.
- Blood (about 4 tablespoons) will be drawn to check your immune system.
At 2 months after the transplant, blood (about 4 tablespoons) will be drawn to check your immune system.
If you have MM, you will have a bone survey once a year.
If the study doctor thinks it is needed based on side effects you may be having, additional follow-up tests will be performed.
You may be contacted by phone 1-2 times a year to ask about the status of the disease. These calls will take about 10 minutes to complete.
This is an investigational study. All of the drugs used in this study are commercially available and FDA approved. However, it is investigational to give high-dose cyclophosphamide for preventing GVHD that may occur after a stem cell transplant from a tissue-mismatched donor.
Up to 72 patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Stem Cell Transplantation
Cyclophosphamide, Fludarabine, Melphalan, Mesna, Rituximab, Stem Cell Transplantation, Thiotepa
UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:18:08-0400
The goal of this clinical research study is to learn if lenalidomide, when given with a stem cell transplant and chemotherapy (cyclophosphamide, fludarabine, and rituximab), can help to co...
Primary Objectives: 1. To compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoie...
Fludarabine, Radiation Therapy, and Rituximab in Treating Patients Who Are Undergoing Donor Stem Cell Transplant Followed by Rituximab for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Did Not Respond to Previous Treatment With Fludarabi
RATIONALE: Giving low doses of chemotherapy, such as fludarabine,, radiation therapy, and rituximab before a donor stem cell transplant and rituximab after a donor stem cell transplant hel...
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in che...
This randomized phase II trial studies how well giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before donor hematopoietic cell transplant works in t...
High-dose chemotherapy and autologous stem cell transplantation (ASCT) is the current standard of care for relapsed non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Conditioning regimens with hig...
Mantle-cell lymphoma is generally incurable. Despite high rates of complete response after initial immunochemotherapy followed by autologous stem-cell transplantation, patients have relapses. We inves...
This phase 1 study (clinical trial NCT00477815) was conducted to determine the maximum tolerated dose (MTD) of yttrium-90 ibritumomab tiuxetan ((90)Y-Zevalin) with high dose melphalan (HDM) therapy in...
High-dose melphalan is an important component of conditioning regimens for patients undergoing hematopoietic stem cell transplantation. The current dosing strategy based on body surface area results i...
High-dose melphalan and autologous stem cell transplantation (ASCT) are associated with high symptom burden. This study aimed to explore multiple myeloma (MM) patients' experience of symptom frequency...
Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.
The transfer of STEM CELLS from one individual to another within the same species (TRANSPLANTATION, HOMOLOGOUS) or between species (XENOTRANSPLANTATION), or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). The source and location of the stem cells determines their potency or pluripotency to differentiate into various cell types.
The transference of BONE MARROW from one human or animal to another for a variety of purposes including HEMATOPOIETIC STEM CELL TRANSPLANTATION or MESENCHYMAL STEM CELL TRANSPLANTATION.
Transfer of MESENCHYMAL STEM CELLS between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS).
A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE.
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...
Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers) - Mouth cancer can develop on the lip, the tongue, the floor...