Clinical Trials Using Busulfan

Clinical trials are research studies that involve people. The clinical trials on this list are studying Busulfan. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 60
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  • Iobenguane I-131 or Crizotinib and Standard Therapy in Treating Younger Patients with Newly-Diagnosed High-Risk Neuroblastoma or Ganglioneuroblastoma

    This phase III trial studies iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or crizotinib and standard therapy may work better compared to crizotinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
    Location: 135 locations

  • The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL

    This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients diagnosed with B-ALL who are candidates for HCT will be screened by NGS-MRD on a test of bone marrow done before the HCT. Subjects who are pre-HCT NGS-MRD negative will be eligible to receive a non-TBI conditioning regimen as part of the treatment cohort of the study. Subjects who are pre-HCT NGS-MRD positive will be treated as per treating center standard and will be followed in an observational cohort (HCT center standard of care).
    Location: 7 locations

  • Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503)

    This is a clinical trial that will compare survival and sickle related outcomes in adolescents and young adults with severe sickle cell disease after bone marrow transplantation and standard of care. The primary outcome is 2-year overall survival.
    Location: 6 locations

  • Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults with Blood Cancers Undergoing Donor Stem Cell Transplant

    This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body’s normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.
    Location: 8 locations

  • Venetoclax, Busulfan, Fludarabine, and Azacitidine in Treating Patients with High Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Myelodysplastic / Myeloproliferative Neoplasm Overlap Syndromes Undergoing Donor Stem Cell Transplantation

    This phase I trial studies the best dose and side effects of venetoclax when given together with busulfan, fludarabine, and azacitidine in treating patients with high risk acute myeloid leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, or myelodysplastic syndrome / myeloproliferative neoplasm undergoing donor hematopoietic stem cell transplantation. Drugs used in chemotherapy, such as venetoclax, busulfan, fludarabine, and azacitidine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: 2 locations

  • Donor Partial Immune Cell Depletion for the Treatment of Hematologic Malignancies

    This trial studies how well donor stem cell transplantation with alpha / beta T cell and B cell depletion (partial Immune Cell Depletion) works in treating patients with hematologic malignancies. Alpha / beta T cell and B cell depletion is a new method of cell processing for stem cell transplants with an unrelated donor or partially matched related donor using the CliniMACS device. There is a higher rate of complications using cells from an unrelated or partially matched related donor. T cells within the donor cells may cause a complication called graft versus host disease, where the transplanted cells from a donor can attack the body's normal cells. Donated B cells can sometimes be infected with a virus (Epstein Bar Virus or EBV) which may result in the development of enlarged lymph nodes (lymphoproliferative disorder). Alpha / beta T cell and B cell depletion may reduce some of the complications of the transplant and decrease the time it takes for the new stem cells to grow in the body.
    Location: 2 locations

  • Ruxolitinib for the Treatment of Graft Versus Host Disease Following Stem Cell Transplant in Patients with Primary and Secondary Myelofibrosis

    This phase II trial studies how well administering ruxolitinib before, during, and after allogeneic hematopoietic stem cell transplantation works in preventing graft versus host disease and improving transplant outcomes in patients with primary and secondary myelofibrosis. Donor hematopoietic stem cell transplantation (HSCT) is currently the only treatment with proven curative potential for myelofibrosis, however, myelofibrosis patients have a high risk for developing graft versus host disease post-transplant. Graft versus host disease is a condition where the transplanted cells from a donor can attack the body's normal cells. Ruxolitinib, a janus-associated kinase (JAK) inhibitor, is known to decrease inflammatory signals, which may reduce spleen size and decrease symptoms such as night sweats and weight loss. Administering ruxolitinib before, during, and after transplant may decrease the incidence and severity of graft versus host disease, increase survival, and improve quality of life in patients with primary and secondary myelofibrosis.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Allogeneic Hematopoietic Stem Cell Transplant for People With Primary Immunodeficiency Diseases

    Background: During a transplant, blood stem cells from one person are given to someone else. The cells grow into the different cells that make up the immune system. This can cure people with certain immunodeficiencies. But transplant has many risks and complications. Objective: To see if stem cell transplant can be successfully performed in people with primary immunodeficiency disease and cure them. Eligibility: People ages 4-69 for whom a primary immunodeficiency has caused significant health problems and either standard management has not worked or there are no standard management options, along with their donors Design: Donors will be screened under protocol 01-C-0129. They will donate blood or bone marrow. Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests CT or PET scans Before transplant, participants will have dental and eye exams. They will have a bone marrow biopsy. For this, a needle will be inserted through the skin into the pelvis to remove marrow. Participants will be hospitalized before their transplant. They will have a central catheter put into a vein in their chest or neck. They will get medications through the catheter to prevent complications. Participants will get stem cells through the catheter. They will stay in the hospital for at least 4 weeks. They will give blood, urine, bone marrow, and stool samples. They may need blood transfusions. They may need more scans. They will take more medications. Participants will have visits on days 30, 60, 100, 180, and 360, and 24 months after the transplant. Then they will have visits once a year for about 5 years
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Donor CD8+ Memory T-Cells for the Treatment of Myelodysplastic Syndrome, Acute Leukemia, or Chronic Myelogenous Leukemia

    This phase II trial studies the effect of donor CD8+ memory T-cells in treating patients with myelodysplastic syndrome, acute leukemia, or chronic myelogenous leukemia. Transplants may cure cancer through two ways. 1) The chemotherapy and radiation therapy received as part of a transplant is a high dose and may eliminate cancer cells, and 2) The donor cells themselves once growing in the body after transplant may eliminate cancer cells: the process by which the donor cells eliminate cancer cells is called “graft versus leukemia / myelodysplastic syndrome” (GVL). Once the donor immune cells are growing in the body, they too may recognize the body as foreign and “attack” the normal body tissue in a process called graft-versus-host-disease (GvHD). One standard method to eliminate GvHD is to select only the donor ‘stem cells’ (called ‘CD34+ stem cells’) in the graft and remove all donor immune cells. This strategy effectively eliminates the risks of GvHD and reduces the complications of a transplant. Yet removing all the donor immune cells from the donor graft may be associated with increased infections and a higher risk of the cancer returning after the transplant because of limited GVL. Many transplant centers use a CD34+ stem cell graft (depleted of immune cells) to reduce GvHD and rely on the intensity of the transplant chemotherapy and radiation therapy to eradicate all the cancer cells. This study will investigate if adding back a part of the donor immune cells, called CD8+ memory T-cells, to the CD34+ stem cell graft will allow for beneficial GVL effects yet without the harmful GvHD effects.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • Giving Chemotherapy and rATG for a Shortened Amount of Time before a Donor Stem Cell Transplantation for the Treatment of Patients with Blood Cancers

    This phase I trial studies the side effects of giving chemotherapy and a drug called rATG for a shorter period of time before a donor stem cell transplant in treating patients with blood cancers. This study will also look at whether the condensed regimen can shorten hospitalization following the transplantation. A chemotherapy regimen with the drugs busulfan, melphalan, and fludarabine may kill cancer cells in the body, making room in the bone marrow for new blood stem cells to grow and reducing the chance of transplanted cell rejection. The chemotherapy drugs work to interrupt the DNA (genetic information) in the cancer cells, stopping the cells from dividing and causing them to die. rATG targets and deactivates white blood cells called T cells that survive the chemotherapy. T cells may see the donor’s cells as foreign, causing a serious condition called graft-versus-host disease (GVHD). rATG helps prevent the donor stem cells from being rejected. Giving chemotherapy and rATG for a shorter period of time before a donor stem cell transplantation may help in reducing the number of side effects and shortening hospitalization following the transplantation.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Optimizing PTCy Dose and Timing

    Background: Stem cell or bone marrow transplants can cure or control blood cancers. Sometimes the donor cells see the recipient s body as foreign. This can cause complications. A high dose of the drug cyclophosphamide (PTCy) can help reduce these risks. Researchers want to see if a lower dose of PTCy can have the same benefits. Objective: To see if a lower dose of PTCy will help people with blood cancers have a more successful transplant and fewer side effects. Eligibility: People ages 15-65 with leukemia, lymphoma, or multiple myeloma that is not curable with standard therapy and is at high risk of returning without transplant, and their healthy adult relatives Design: Transplant participants will be screened with: Blood, urine, breathing, and heart tests Scans Chest x-ray Bone marrow samples: A needle inserted into the participant s pelvis will remove marrow and a bone fragment. Transplant recipients will stay at the hospital and be prepped with chemotherapy over 6 days for the transplant. They will get stem cells through a catheter in the chest or neck. They will get the cyclophosphamide chemotherapy. They will stay in the hospital about 4 more weeks. They will have blood transfusions. They will have frequent blood tests and 2 bone marrow samples within 1 year after the transplant. Donor participants will be screened with: Blood, urine, and heart tests Chest x-ray Scans Donor participants will have bone marrow taken from their pelvis or stem cells taken from their blood. For the blood donation, blood will be taken from a vein in one arm, move through a machine to remove white blood cells, and be returned through a vein in the other arm. Participation will last up to 5 years....
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma

    Background: Lymphoma is a type of blood cancer. Blood cell transplant can cure some people with lymphoma. Researchers want to see if they can limit the complications transplant can cause. Objective: To test if a stem cell transplant can cure or control lymphoma. Also to test if new ways of getting a recipient ready for a transplant may result in fewer problems and side effects. Eligibility: Recipients: People ages 12 and older with peripheral T cell lymphoma that does not respond to standard treatments Donors: Healthy people ages 18 and older whose relative has lymphoma Design: Participants will be screened with: Physical exam Blood and urine tests Bone marrow biopsy: A needle inserted into the participant s hip bone will remove marrow. Donors will also be screened with: X-rays Recipients will also be screened with: Lying in scanners that take pictures of the body Tumor sample Donors may donate blood. They will take daily shots for 5 7 days. They will have apheresis: A machine will take blood from one arm and take out their stem cells. The blood will be returned into the other arm. Recipients will be hospitalized at least 2 weeks before transplant. They will get a catheter: A plastic tube will be inserted into a vein in the neck or upper chest. They will get antibody therapy or chemotherapy. Recipients will get the transplant through their catheter. Recipients will stay in the hospital several weeks after transplant. They will get blood transfusions. They will take drugs including chemotherapy for about 2 months. Recipients will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Vorinostat in Preventing Graft Versus Host Disease in Children, Adolescents, and Young Adults Undergoing Blood and Bone Marrow Transplant

    This phase I / II trial studies the side effects and best dose of vorinostat in preventing graft versus host disease in children, adolescents, and young adults who are undergoing unrelated donor blood and bone marrow transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells, called graft-versus-host disease. During this process, chemicals (called cytokines) are released that may damage certain body tissues, including the gut, liver and skin. Vorinostat may be an effective treatment for graft-versus-host disease caused by a bone marrow transplant.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • CD45RA Depleted T Cell Infusion after Alpha / Beta Depleted Stem Cell Transplant for the Reduction of Complications in Patients at Risk for Viral or Fungal Infections

    This phase I trial studies the side effects of CD45RA depleted T cell infusion given after an alpha / beta depleted stem cell transplant, and to see how well it works in reducing complications in patients at risk for viral or fungal infections. There is a higher rate of complications using cells from an unrelated or partially matched related donor. Some donor cells may cause a complication called graft versus host disease (GVHD) and an infection with the Epstein-Barr virus (EBV). In this study, the CliniMACs device is used before the transplant to remove alpha / beta T cells that may cause GVHD and B cells that carry EBV. The device is also used to remove CD45RA T cells. Giving CD45RA depleted T cells after the transplant may reduce some of the complications of the transplant and decrease the time it takes for the new stem cells to grow in the body.
    Location: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

  • Donor T Cell Depletion in Preventing Graft Versus Host Disease in Patients with Blood Cancer Undergoing a Donor Stem Cell Transplant

    This phase II trial studies donor T cell depletion in preventing graft versus host disease (GVHD) in patients with blood cancer undergoing a donor stem cell transplant. Donor stem cell transplants, especially in the mismatched donor setting, are associated with increased risk for GVHD, a condition where the transplanted donor white blood cells attack your body’s normal tissues. Using a cell separation device may remove a subset of white blood cells (called alpha / beta T cells) from the donor product before the product is transplanted. This study is being done to assess whether this manipulation (called selective T cell depletion) will reduce the risk of GVHD and improve transplant outcome.
    Location: Dana-Farber Cancer Institute, Boston, Massachusetts

  • Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and / or Dysregulation

    Background: Blood stem cells in the bone marrow make all the cells to normally defend a body against disease. Allogeneic blood or marrow transplant is when these stem cells are transferred from one person to another. Researchers think this treatment can provide a new, healthy immune system to correct T-cell problems in some people. Objective: To see if allogeneic blood or bone marrow transplant is safe and effective in treating people with T-cell problems. Eligibility: Donors: Healthy people ages 4 and older Recipients: People the same age with abnormal T-cell function causing health problems Design: All participants will be screened with: - Medical history - Physical exam - Blood, heart, and urine tests Donors will also have an electrocardiogram and chest x-ray. They may have veins tested or a pre-anesthesia test. Recipients will also have lung tests. Some participants will have scans and / or bone marrow collected by needle in the hip bones. Donors will learn about medicines and activities to avoid and repeat some screening tests. Some donors will stay in the hospital overnight and have bone marrow collected with anesthesia. Other donors will get shots for several days to stimulate cells. They will have blood removed by plastic tube (IV) in an arm vein. A machine will remove stem cells and return the rest of the blood to the other arm. Recipients will have: - More bone marrow and a small fragment of bone removed - Dental, diet, and social worker consultations - Scans - Chemotherapy and antibody therapy for 2 weeks - Catheter inserted in a chest or neck vein to receive donor stem cells - A hospital stay for several weeks with more medicines and procedures - Multiple follow-up visits...
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • A Safety and Efficacy Study Evaluating CTX001 in Subjects With Transfusion-Dependent β-Thalassemia

    This is a single-arm, open-label, multi-site, single-dose Phase 1 / 2 study in subjects with transfusion-dependent β-thalassemia (TDT). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using CTX001.
    Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

  • A Study to Assess the Safety, Tolerability, and Efficacy of BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Sickle Cell Disease

    This is an open label, multicenter, Phase 1 / 2 study in approximately eight adults with severe Sickle Cell Disease (SCD). The study will evaluate the safety, tolerability, and efficacy of autologous hematopoietic stem cell transplantation using BIVV003.
    Location: Wayne State University / Karmanos Cancer Institute, Detroit, Michigan

  • Donor Stem Cell Transplant using Alpha / Beta+ T-Cell Depletion in Treating Patients with Hematologic Malignancies

    This phase II trial studies the side effects of donor stem cell transplant using allogeneic TCR alpha / beta-positive T-lymphocyte-depleted peripheral blood stem cells (alpha / beta positive [+] T-cell depletion) in treating patients with hematologic malignancies. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient’s immune cells and help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells called graft-versus-host disease. Removing the T cells from the donor cells before the transplant may stop this from happening.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Risk-Adjusted Combination Chemotherapy Alone in Treating Patients with Fanconi Anemia Undergoing Hematopoietic Stem Cell Transplantation

    This phase II trial studies how well risk-adjusted combination chemotherapy alone works in treating patients with Fanconi anemia undergoing donor hematopoietic stem cell transplantation. Drugs used in chemotherapy, such as busulfan, fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient’s bone marrow for new blood-forming cells (stem cells) to grow. Dose of combination chemotherapy based on the patients age and bone marrow disease status, may decrease chemotherapy-related side effects while maximizing the effectiveness of disease control.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Stem Cell Transplant to Treat Patients with Favorable or Intermediate Risk, Minimal Residual Disease-Negative, Acute Myeloid Leukemia

    This phase II trial studies how well autologous stem cell transplant works in treating patients with favorable or intermediate risk, minimal residual disease (MRD)-negative, acute myeloid leukemia. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body. After treatment, stem cells are collected from the patient's blood and stored. Higher dose chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Donor Stem Cell Transplant in Treating Younger Patients with Hematologic Malignancies or Myelodysplasia

    This phase I / II trial studies how well stem cell transplant from partially matched related donors works in treating younger patients with hematologic malignancies or myelodysplasia. Donor stem cell transplant is a procedure in which a patient receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. Ideally, patients undergoing donor stem cell transplant receive a stem cell graft from a matched sibling; however, less than 30% of patients will have such a donor. There is a high likelihood of being unable to identify a perfect matched unrelated donor. Stem cell transplant from a partially matched related donor may result in result in successful engraftment and rapid immune rebuilding while maintaining a low risk of graft versus host disease.
    Location: Nationwide Children's Hospital, Columbus, Ohio

  • Donor Stem Cell Transplant in Treating Patients with Blood Cancer

    This phase II trial studies how well donor stem cell transplant works in treating patients with blood cancer. Giving total-body irradiation before a donor transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota

  • Busulfan, Fludarabine, Donor Stem Cell Transplant, and Cyclophosphamide in Treating Patients with Multiple Myeloma or Myelofibrosis

    This phase II trial studies how well busulfan, fludarabine, donor stem cell transplant, and cyclophosphamide in treating patients with multiple myeloma or myelofibrosis. Drugs used in chemotherapy, such as busulfan, fludarabine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving busulfan and fludarabine before and cyclophosphamide after donor stem cell may work better in treating patients with multiple myeloma or myelofibrosis.
    Location: Huntsman Cancer Institute / University of Utah, Salt Lake City, Utah

  • Olaparib and High-Dose Chemotherapy in Treating Patients with Relapsed or Refractory Lymphomas Undergoing Stem Cell Transplant

    This phase I trial studies the side effects and best dose of olaparib when given together with high-dose chemotherapy in treating patients with lymphomas that have come back (relapsed) or does not treatment (refractory) and are undergoing stem cell transplant. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Drugs used in chemotherapy, such as vorinostat, gemcitabine, busulfan, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving olaparib and high-dose chemotherapy together may work better in treating patients with relapsed / refractory lymphomas undergoing stem cell transplant than with chemotherapy alone.
    Location: M D Anderson Cancer Center, Houston, Texas


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