Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Lymphoid

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Hodgkin Disease

Neoplasms by Histologic Type

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Myeloproliferative Disorders

Bone Marrow Diseases

Myeloid Leukemia

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Hodgkin Lymphoma

Chronic Myeloproliferative Disorders

CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)

CD8 Depleted Donor Lymphocyte

Richard Champlin, MD, BS

Primary Objectives:

To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and Hodgkin's Lymphoma (HD).

Secondary Objectives:

* To evaluate safety and treatment related mortality after CD8 depleted DLI.
* To evaluate the time to onset of GVHD following DLI and response to GVHD treatment.
* To evaluate the incidence and timing of pancytopenia following DLI.
* To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM).
* To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions.
* To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.

CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation

CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation

Eligix

M.D. Anderson Cancer Center

Lymphoma, Non-Hodgkin

Database

Syed Akhtar, MD

Prospective Data Collection of Newly Diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma Cases

Prospective Data Collection of Newly Diagnosed HD and NHL.

King Faisal Specialist Hospital & Research Center

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Hematologic Neoplasms

Leukemia, Myeloid, Acute

Acute Disease

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Panobinostat

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Patients with ALL and AML will be treated in one arm of the study.

Patients with NHL or HD will be treated in one arm of the study.

Dose will be assigned at study entry. Patients will take panobinostat orally 3 times a week given on a Monday, Wednesday, Friday schedule, every week. One course is 28 days (4 weeks). Patients will get 2 courses and may receive up to 8 courses total.

All patients will receive 70 mg of intrathecal cytarabine on day "0" of course 1. The day "0" dose must be given at least 24 hours prior to initiation of panobinostat. Omit the day "0" dose of intrathecal cytarabine if the patient received intrathecal therapy within 72 hours of treatment.

All patients will receive 70 mg of intrathecal cytarabine on day "29" of course 1-8 in conjunction with their disease evaluation.

Dose will be assigned at study entry. Patients will take panobinostat orally 3 times a week on a Monday, Wednesday, Friday schedule, every other week. Once course is 28 days (4 weeks). Patients will get 2 course and may receive up to 8 courses of therapy.

Julio Barredo, MD

This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Hodgkin's Disease (HD) or Non-Hodgkin's Lymphoma (NHL). Panobinostat is a new drug that is considered investigational because it has not been approved in the United States by the Food and Drug Administration (FDA), or in any other country. Panobinostat is a histone deacetylase inhibitor (HDACi) and interferes with gene expression found in cells causing them to stop growing or die. Panobinostat has been used in several hundred adults who had leukemia, HD, NHL and other solid tumors. Panobinostat has not been given to children.

This is a phase I study. In a phase I study, drugs are tested to the highest dose that can be safely given. Drugs are given at gradually increasing dosages until there are unacceptable side effects. The goal of the Phase I study is to find out the dose of panobinostat that can be safely given to children with relapsed ALL, AML, HD and NHL.

A Study Of Panobinostat In Children With Refractory Hematologic Malignancies

A Phase I Dose Finding Study Of Panobinostat In Children With Refractory Hematologic Malignancies

Novartis

Therapeutic Advances in Childhood Leukemia Consortium

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Syndrome

Communicable Diseases

Philadelphia Chromosome

Preleukemia

Myelodysplastic Syndromes

Histiocytosis, Langerhans-Cell

Histiocytosis

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Langerhans Cell Histiocytosis

Antirheumatic Agents

Fludarabine

Fludarabine phosphate

Rituximab

Melphalan

Mycophenolic Acid

Tacrolimus

Thymoglobulin

Busulfan

Thiotepa

Clofarabine

Antilymphocyte Serum

Antineoplastic Agents, Immunological

Calcineurin Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Myeloablative Regimen: Rituxan 375 mg/m\^2 (B cell malignancy) by vein (IV) on Day -10; Busulfan AUC 4,000 IV either as an outpatient prior to admission or as an inpatient on Day -9; Clofarabine 30 mg/m\^2 IV Day -7 to Day -4; ATG 1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3; Fludarabine 10 mg/m\^2 IV on Days -7 to -4; Total Body Irradiation (TBI) 2 Gy on Day -3; with Cord Blood infusions on Day 0.

Reduced Intensity: Fludarabine 40 mg/m\^2 IV on Days -5 to -2; Melphalan 140 mg/m\^2 IV on Day -2; ATG 1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3; with Cord Blood infusions on Day 0.

140 mg/m2 by vein on Day -2 only for Fludarabine + Melphalan group.

10 mg/m2 by vein on Days -7 to -4 for Melphalan + Thiotepa + Fludarabine group, or 40 mg on Days -5 to -2 for Fludarabine + Melphalan group.

15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth twice a day from Days -3 to +100 in the absence of Graft vs Host Disease (GvHD).

Mycophenolate mofetil

Starting dose 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on Day -2 and tapered around Day +180 if no Graft vs Host Disease (GvHD) is present.

Cord blood infusion on Day 0. Each participant will receive cells from one unexpanded cord blood sample plus cells from a second cord blood sample that has undergone fucosylation.

Cord Blood Infusion

375 mg/m\^2 by vein on Day -10 for B cell malignancy.

1.25 mg/Kg by vein on Day -4.

1.75 mg/Kg by vein on Day -3.

Busulfan per standard of care, test dose either as an outpatient prior to admission or as an inpatient on Day -9. Busulfan pharmacokinetics performed with test dose and the first dose on Day -7 per standard of care. Doses of Days -5 and -4 subsequently adjusted to target an AUC of 4,000 microMol.min-1.

Total Body Irradiation (TBI)

Elizabeth Shpall, MD

The goal of this clinical research study is to learn if it is safe and feasible to transplant changed cord blood for patients with leukemia or lymphoma. Researchers also want to learn if this can help to control the disease.

The cord blood will be changed to make use of sugar that is found in small amounts in blood cells. It plays a role in signaling where in the body the transplanted cells should go to. Adding more sugars to the cord blood cells in the laboratory is designed to help the cord blood cells find their way faster to the bone marrow. This may help your blood counts to recover faster. This process is called fucosylation.

Anti-thymocyte globulin (ATG) is a protein that removes immune cells that cause damage to the body.

Clofarabine is designed to interfere with the growth and development of cancer cells.

Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die. This chemotherapy is also designed to block your body's ability to reject the donor's bone marrow cells.

Melphalan and busulfan are designed to bind to the DNA of cells, which may cause cancer cells to die.

Mycophenolate mofetil (MMF) and tacrolimus are designed to block the donor cells from growing and spreading in a way that could cause graft versus host disease (GVHD -- a condition in which transplanted tissue attacks the recipient's body). This may help to prevent GVHD.

Rituximab is designed to attach to cancer cells, which may cause them to die.

Central Venous Catheter Placement:

You will first have a central venous catheter (CVC) placed. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for it.

The chemotherapy, some of the other drugs in this study, and the cord blood transplant will be given by vein through your CVC. Blood samples will also be drawn through your CVC. The CVC will remain in your body for about 2-5 months.

Study Plans:

If you agree to take part in this study, your doctor will choose one of the following 2 study plans based on the disease and your age and medical history.

Fludarabine/Clofarabine/Busulfan/Rituximab/Total Body Irradiation:

If you are between 1 and 55 years of age and can receive high-dose chemotherapy, or you are between 55 and 65 years old and your doctor agrees, you will receive fludarabine, clofarabine, busulfan, ATG, total body irradiation, and possibly rituximab.

You will receive a test dose of busulfan by vein over 60 minutes as an outpatient. If the test dose cannot be given as an outpatient, you will be admitted to the hospital on Day -10 for intravenous (IV) fluids and will receive the busulfan test dose on Day -9. This low-level "test" dose of busulfan is to check how the level of busulfan in your blood changes over time. This information will be used to decide the next dose needed to reach the target blood level that matches your body size.

About 11 samples of blood will be drawn for pharmacokinetic (PK) testing of busulfan. PK testing measures the amount of study drug in the body at different time points. These blood samples will be drawn at various timepoints starting before the busulfan infusion and continuing over about the next 11 hours. The blood samples will be repeated again with the first day of high-dose busulfan treatment. Each sample will be about 1 teaspoon of blood. A temporary heparin lock will be placed in your vein to lower the number of needle sticks needed for these draws. If it is not possible for the PK tests to be performed for technical or scheduling reasons, you will receive the standard fixed dose of busulfan.

If you will receive the test dose as an outpatient, you will be admitted to the hospital on Day -8 and will receive fluids by vein. If appropriate for the disease, you will receive rituximab by vein over 4-6 hours on Day -8.

If you will receive the test dose as an inpatient, you will be admitted on Day -10 and will receive fluids by vein. If appropriate for the disease, you will receive rituximab by vein over 4-6 hours on Day -10.

On Days -7 through -4, you will receive fludarabine by vein over 1 hour, clofarabine by vein over 1 hour, and busulfan by vein over 3 hours. You will receive ATG on Days -4 and -3. On Day -3, you will receive a single treatment of low-dose total body irradiation. You will "rest" (not receive chemotherapy drugs) on Days -2 and -1. Day 0 is the day of the cord blood transplant, so the negative day numbers are used to label the treatment days before the transplant.

All chemotherapy drugs, fluids, and other drugs that must be given by vein will be infused through the catheter. Once the back-up cells are collected, all participants will be admitted to the hospital as indicated by their assigned treatment plan schedule.

Fludarabine/Melphalan:

If your doctor chooses fludarabine and melphalan, you will have the following schedule:

* On Day -6 (6 days before your transplant), you will be admitted to the hospital and will receive fluids by vein.
* On Days -5, -4, and -3, you will receive fludarabine by vein over 30 minutes.
* On Days -4 and -3, you will receive ATG by vein over 4 hours.
* On Day -2, you will receive fludarabine by vein over 30 minutes and melphalan by vein over 30 minutes.
* On Day -1, you will not receive any drugs.
* On Day 0, you will receive your cord blood transplant through the CVC.

Supportive Drugs:

Starting on Day -3, you will receive mycophenolate mofetil as a tablet by mouth 2 times a day. If you are not able to take the tablet by mouth, you will receive MMF by vein over 2 hours 2 times a day. If you do not have GVHD at Day 100 after your cord blood transplant, the dose of MMF will be gradually lowered. If you have GVHD, MMF may be stopped 7 days after the GVHD is controlled.

Starting on Day -2, you will receive tacrolimus by vein as a continuous (nonstop) infusion until you are able to take it by mouth. You will then take tacrolimus by mouth 2 times a day for about 6 months. After that, your tacrolimus dose may be gradually lowered if you do not have GVHD. Your doctor will discuss this with you.

Starting on Day 0, you will receive filgrastim (G-CSF) through a needle under the skin 1 time a day every day until your white blood count begins to recover. Filgrastim is designed to help cells in the bone marrow to divide, which helps raise white blood cells counts more quickly, lower fever, and decrease the risk of infection.

Study Visits:

At about 1, 3, 6, and 12 months after the transplant:

* You will have a physical exam.
* You will be checked for possible reactions to the transplant and study drugs, including GVHD.
* Blood (about 4 teaspoons) will be drawn for routine tests, to check for CMV antibodies, and for genetic tests to learn if the donor's cells have "taken". The routine blood tests will be repeated as often as the doctor thinks is needed.
* If the doctor thinks it is needed, you will have a bone marrow aspiration to check the status of the disease.

You will need to stay in the hospital for about 4 weeks. After you leave the hospital, you will continue as an outpatient in the hospital area, which means you will have to stay close enough to be able to come back for any visits for about 100 days after the transplant.

Length of Participation:

You will be on study for up to 1 year. You will be taken off study early if the disease gets worse, if intolerable side effects occur, if the cord blood is infected and cannot be transplanted, if you are unable to follow study directions, or if your doctor thinks it is in your best interest.

This is an investigational study. Fucosylation is not an FDA-approved process. It is currently being used for research purposes only. Fludarabine, busulfan, clofarabine, melphalan, mycophenolate mofetil, tacrolimus, and rituximab are FDA approved and commercially available to be given to patients with leukemia or lymphoma having a cord blood transplant. Total body irradiation is delivered using FDA-approved and commercially available methods.

Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies

Engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion.

Engraftment date is the first day of three (3) consecutive days that the absolute neutrophil count (ANC) exceeds 0.5 x109/L. Time measured in days.

American Stem Cell, Inc.

National Cancer Institute (NCI)

Thrombocytosis

Thrombocythemia, Essential

Essential Thrombocythemia

Cyclophosphamide

Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.

Fludarabine 30 mg/m\^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4

Peripheral Blood Stem Cell Transplant

Scott R Solomon, MD

In this study, patients will receive a myeloablative preparative regimen consisting of fludarabine and total body irradiation (TBI), followed by a T cell replete, mobilized peripheral blood stem cell (PBSC) allograft from a partially matched related donor. All patients will receive post-transplant Cy in addition to standard post transplant immunosuppression with tacrolimus and MMF. The treatment protocol will be essentially identical to the prior study, with the exception of the substitution of TBI for Busulfan. The investigators hypothesize that this change will significantly reduce the risk of HC, while maintaining the efficacy of the transplant.

Historically, haploidentical HSCT has been associated with significant risks of graft rejection and severe graft versus host disease (GVHD), leading to high treatment related mortality and poor outcomes. The risk of engraftment failure and GVHD may be reduced in intensively conditioned recipients of grafts that have been rigorously depleted of T cells, but the risks of serious infection and death from prolonged immune compromise in these patients remains high. Recently, investigators from Johns Hopkins University demonstrated a new approach to haploidentical transplantation, utilizing a nonmyeloablative preparative regimen, followed by a T cell-replete bone marrow infusion and post-transplantation immunosuppression with high dose Cyclophosphamide (Cy), tacrolimus, and MMF. Clinical studies have shown this approach to be safe and effective with a low incidence of graft rejection, GVHD, and treatment-related mortality. Relapse represents the major cause of treatment failure in these patients, particularly with high-risk myeloid malignancies.

In order to decrease this relapse risk in high-risk patients, the investigators initiated a myeloablative haploidentical HSCT study in January 2009 utilizing Busulfan-based conditioning, post-transplant Cy, and PBSC, instead of BM, as the stem cell source. Outcomes of the 15 patients transplanted to date have been promising with 100% engraftment, low rates of treatment-related mortality, relapse and GVHD, and excellent survival rates. An unexpected outcome of the study was a higher-than-expected rate of BK virus-induced hemorrhagic cystitis (HC) occurring in 7 of 14 evaluable patients. Although there were no deaths attributable to HC, it was associated with significant morbidity in some patients.

HC is a recognized complication of allogeneic transplant therapy. Late onset HC, occurring after engraftment, is due almost exclusively to reactivation of the polyoma BK virus (BKV). Other important risk factors associated with HC include Busulfan-based conditioning, acute GVHD, HLA mismatched transplants, and use of bone marrow as the stem cell source. TBI-based conditioning, prior to myeloablative allogeneic transplant, has been associated with significantly less HC than Busulfan-based conditioning in both retrospective and prospective randomized trials.

Eighteen patients will be accrued to this study. The primary end point of this study is the incidence of HC. The investigators will also examine the incidence of acute and chronic GVHD, engraftment, degree of donor-host chimerism, transplant related morbidity and mortality, as well as disease-free and overall survival. Stopping rules will minimize the risk of untoward or unexpected side effects.

Total Body Irradiation/Fludarabine Based Ablative Haploidentical Transplant for Hematologic Diseases

A Phase II Trial of Total Body Irradiation-Based Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies

1.1 To estimate the incidence of BK virus-associated hemorrhagic cystitis following a TBI-based myeloablative haploidentical HSCT in patients with high risk hematologic malignancies.

To obtain estimate of overall survival (OS)

Characterize donor hematopoietic chimerism in peripheral blood at day 30 after HSCT.

Blood and Marrow Transplant Group of Georgia

Northside Hospital, Inc.

Haplo transplant

Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.

Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4

Myeloablative Haploidentical Transplant

Age, Categorical

Sex: Female, Male

White

Black/African America

Race/Ethnicity, Customized

Scott R. Solomon, MD (Principal Investigator)

Percentage of Patients Experiencing Hemorrhagic Cystitis Post Transplant

Survival

Percentage of Participatns With Donor Chimerism Post-transplant

Disease Free Survival (DFS) Percentage

Non-relapsed Mortality (NRM) Percentage

Relapse Rate

Cumulative Incidence of Chronic Graft-versus-host Disease

Haplo transplant

Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.

Fludarabine 30 mg/m\^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4

Patient follow up x6 months

Overall Study

A Al-Zahrani, M.D.

Functional Assessment of Cancer Therapy - Bone Marrow Transplant

Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation	NCT00038818	Chronic Myeloge... Multiple Myelom... Non Hodgkin's L... Hodgkin's Disea... Chronic Lymphoc...	CD8 Depleted Do...	-	M.D. Anderson Cancer Center
Prospective Data Collection of Newly Diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma Cases	NCT00538551	Hodgkin Disease Lymphoma, Non-H...	Database	14 Years - 85 Years	King Faisal Specialist Hospital & Research Center
A Study Of Panobinostat In Children With Refractory Hematologic Malignancies	NCT01321346	Lymphoblastic L... Myelogenous Leu... Hodgkin's Disea... Non-Hodgkin's L...	Panobinostat Cytarabine Panobinostat	8 Years - 21 Years	Therapeutic Advances in Childhood Leukemia Consortium
Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies	NCT01471067	Blood And Marro... Leukemia Lymphoma Transplantation... Transplantation...	Melphalan Fludarabine Mycophenolate m... Tacrolimus Cord Blood Infu... Rituximab ATG Busulfan Clofarabine Total Body Irra...	1 Year - 80 Years	M.D. Anderson Cancer Center
Total Body Irradiation/Fludarabine Based Ablative Haploidentical Transplant for Hematologic Diseases	NCT01336712	Chronic Leukemi... Acute Leukemia Hodgkin's Disea... Non-Hodgkin's L... Myelodysplastic...	Peripheral Bloo...	18 Years - 60 Years	Northside Hospital, Inc.
Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies	NCT01471067	Blood And Marro... Leukemia Lymphoma Transplantation... Transplantation...	Melphalan Fludarabine Mycophenolate m... Tacrolimus Cord Blood Infu... Rituximab ATG Busulfan Clofarabine Total Body Irra...	1 Year - 80 Years	M.D. Anderson Cancer Center
Functional Assessment of Cancer Therapy - Bone Marrow Transplant	NCT01490957	Hodgkin Disease Lymphoma, Non-H...	Database	14 Years - 85 Years	King Faisal Specialist Hospital & Research Center

Spots Global Cancer Trial Database for hd

Every month we try and update this database with for hd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hd

Every month we try and update this database with for hd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.