11 Leukemia/MDS 2 1 0 30 42 4 http://clinicaltrials.dfhcc.harvard.edu/trials/4 Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 3 32 http://clinicaltrials.dfhcc.harvard.edu/trials/32 Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia RATIONALE: Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Midostaurin may help daunorubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Midostaurin also may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without midostaurin in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying giving daunorubicin and cytarabine with or without midostaurin followed by high-dose cytarabine and midostaurin to see how well it works in treating patients with newly diagnosed acute myeloid leukemia. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 3 34 http://clinicaltrials.dfhcc.harvard.edu/trials/34 Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with rituximab may kill more cancer cells. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving fludarabine together with rituximab early is more effective than giving fludarabine and rituximab after observation in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how well they work when given early or after observation in treating patients with previously untreated chronic lymphocytic leukemia. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 3 185 http://clinicaltrials.dfhcc.harvard.edu/trials/185 Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotexate or Observation in Treating Patients With Acute Promyelocytic Leukemia RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Sometimes the cancer may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether combination chemotherapy is more effective than observation when given as maintenance therapy in treating acute promyelocytic leukemia. PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and methotrexate to see how well they work when given as maintenance therapy compared with observation after combination chemotherapy in treating patients with acute promyelocytic leukemia. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 3 487 http://clinicaltrials.dfhcc.harvard.edu/trials/487 A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I) Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. There is no recommended standard treatment for relapsed or refractory acute myelogenous leukemia in patients older than 59 years. Cytarabine is the most commonly used drug to treat these patients. This study will determine if there is additional benefit by combining clofarabine with cytarabine. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 3 21 http://clinicaltrials.dfhcc.harvard.edu/trials/21 Study of SNS-595 in Older Patients With Untreated Acute Myeloid Leukemia This study will evaluate the overall remission rate of treatment with SNS 595 Injection in patients at least 60 years of age with previously untreated AML Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 33 http://clinicaltrials.dfhcc.harvard.edu/trials/33 Phase II PKC412 in Aggressive Systemic Mastocytosis and Mast Cell Leukemia To evaluate the efficacy of twice-daily oral doses of PKC412 when administered to patients with ASM/MCL and AHNMD (associated hematological clonal non-mast cell lineage disease) by measuring response rate. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 56 http://clinicaltrials.dfhcc.harvard.edu/trials/56 Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination chemotherapy may be more effective in treating promyelocytic leukemia. PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination chemotherapy works in treating patients with previously untreated promyelocytic leukemia. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 93 http://clinicaltrials.dfhcc.harvard.edu/trials/93 Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL) The study is a two-arm, multi-center trial of Revlimid® and Rituximab, for the frontline treatment of patients with Chronic Lymphocytic Leukemia (CLL) designed and conducted by the CLL Research Consortium (CRC). The purpose of this study is to determine the response rate of the combination of Revlimid® and Rituximab in previously untreated CLL patients in two arms- those aged 65 years and above and those younger than 65. Secondary objectives will evaluate the safety of the combination of Revlimid® and Rituximab, response duration, improvement in hematologic parameters, and the significance of the tumor flare reaction. All patients will have assessment of known prognostic factors for CLL as well as novel prognostic factors will be evaluated for predicting response to treatment. Biologic corollary studies are designed to evaluate the mechanism of Revlimid® in CLL and the combination of Revlimid® and Rituximab. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 176 http://clinicaltrials.dfhcc.harvard.edu/trials/176 Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant That Uses Low Dose Chemotherapy in People With Leukemia or Lymphoma (BMT CTN #0604) A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood have become a treatment option for people with these types of cancers. This study will evaluate the effectiveness of a stem cell transplant using umbilical cord blood, along with lower doses of chemotherapy, to treat people with leukemia or lymphoma. Recruiting 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 238 http://clinicaltrials.dfhcc.harvard.edu/trials/238 ALL Adult Consortium Trial: Adult ALL Trial The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add a drug called PEG-asparaginase. PEG-asparaginase has been given as an injection in the past and has been used in treatment with both children and adults with ALL. Information from those other research studies suggests that intravenous PEG-asparaginase has been administered safely in both children and adults. We hope to gain more information about the participants disease and how it responds to standard chemotherapy drugs used to treat ALL> Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 275 http://clinicaltrials.dfhcc.harvard.edu/trials/275 Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and best dose of bortezomib when given together with daunorubicin and cytarabine and to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 354 http://clinicaltrials.dfhcc.harvard.edu/trials/354 Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia RATIONALE: Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back. PURPOSE: This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 912 http://clinicaltrials.dfhcc.harvard.edu/trials/912 Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 1339 http://clinicaltrials.dfhcc.harvard.edu/trials/1339 Treatment of Older Adults With Acute Lymphoblastic Leukemia The purpose of this study is to determine the safety and effectiveness of a multi-drug regimen (which includes prednisone, vincristine, cytarabine, doxorubicin, 6 mercaptopurine, and methotrexate) which is considered standard treatment for children and young adults with acute lymphoblastic leukemia (ALL), in combination with PEG-asparaginase and clofarabine to treat older adults with ALL. PEG-asparaginase has been used in chemotherapy treatment regimens for both children and adults with ALL. Clofarabine has been used in chemotherapy treatment regimens for children with ALL and has been shown to decrease the number of leukemia cells. Participants with leukemia that has an abnormal chromosome, called the Philadelphia chromosome, will also be given imatinib. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 1345 http://clinicaltrials.dfhcc.harvard.edu/trials/1345 Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that works by preventing cells in the body from growing and dividing. Information from basic and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor growth in people with relapsed or refractory lymphoma. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 2 12 http://clinicaltrials.dfhcc.harvard.edu/trials/12 STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders The purpose of this study is to characterize the safety and efficacy of STA-9090 in subjects with hematologic malignancies. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1/Phase 2 95 http://clinicaltrials.dfhcc.harvard.edu/trials/95 A Phase 1/2a Study of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1/Phase 2 264 http://clinicaltrials.dfhcc.harvard.edu/trials/264 Weekly Subcutaneous Alemtuzumab and Rituximab for Relapsed CLL The purpose of this study is to determine whether the combination of alemtuzumab and rituximab is safe and effective in treating patients with relapsed Chronic Lymphocytic Leukemia (CLL) and to determine whether alemtuzumab can be given as a single weekly subcutaneous dose, together with rituximab. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1/Phase 2 268 http://clinicaltrials.dfhcc.harvard.edu/trials/268 Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia This is a two-part, open-label, Phase I/II study in subjects with relapsed or refractory TdT-positive leukemia for which no standard therapies are expected to result in durable remission. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1/Phase 2 1361 http://clinicaltrials.dfhcc.harvard.edu/trials/1361 A Study of BMS-863233 in Patients With Hematologic Cancer To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1/Phase 2 7 http://clinicaltrials.dfhcc.harvard.edu/trials/7 Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using Prostaglandin E2 (PGE2) The purpose of this research study is to determine the effects of 16, 16 Dimethyl-Prostaglandin E2 (dmPGE2) treatment on umbilical cord blood units to be used in transplantation. dmPGE2 treatment is being tested to see if it can improve the ability of umbilical cord blood stem cells to grow after transplantation. The growth of stem cells after transplantation is sometimes referred to as "engraftment". One of the major problems after umbilical cord transplantation is the time required for engraftment. After transplantation of two umbilical cord blood units, the average time to achieve engraftment is 21 days. In addition, up to 10% of patients who undergo umbilical cord blood transplantation never engraft, a potentially life-threatening condition. In laboratory studies, treatment of umbilical cord blood stem cells with dmPGE2 was shown to enhance engraftment. Recruiting 14 Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/14-hodgkin-s-lymphoma 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1 37 http://clinicaltrials.dfhcc.harvard.edu/trials/37 Laboratory-Treated Peripheral Blood Cell Infusion After Donor Stem Cell Transplant in Treating Patients With Hematologic Cancers or Other Diseases RATIONALE: Giving total-body irradiation and chemotherapy, such as thiotepa and fludarabine, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem 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. Giving methylprednisolone and antithymocyte globulin before transplant and peripheral blood cells that have been treated in the laboratory after transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated peripheral blood cell infusion after donor stem cell transplant in treating patients with hematologic cancers or other diseases. Recruiting 20 Pediatric Blood Related http://clinicaltrials.dfhcc.harvard.edu/diagnoses/20-pediatric-blood-related 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1 46 http://clinicaltrials.dfhcc.harvard.edu/trials/46 Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies The purpose of this study is to determine the dose that can be safely given to see what effect it may have on your cancer and to determine how the drug is distributed in the body. Recruiting 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1 78 http://clinicaltrials.dfhcc.harvard.edu/trials/78 Vaccination With GM-K562 Cells in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) After Allogeneic Hematopoetic Stem Cell Transplantation The purpose of this research study is to determine if the GM-K562/leukemia cell vaccine can be safely given soon after allogeneic marrow or blood stem cell transplant. The GM-K562/leukemia cell vaccine is composed of a cultured cell line that has been genetically modified to secrete GM-CSF, a naturally occuring substance in the body that stimulates the immune system. The vaccine is a mixture of the GM-K562 cells (radiated to prevent them from growing in the participants body) with the participant's previously frozen and killed leukemia cells. By mixing the GM-K562 with the leukemia cells, we would like to study whether this vaccine combination will stimulate the participant's new immune system to recognize and fight against their MDS/AML cancer cells. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1 106 http://clinicaltrials.dfhcc.harvard.edu/trials/106 Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation The purpose of this research study is to collect, freeze and store leukemia cells from the blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (CLL) that is not in clinical remission. This study is a companion study to DF/HCC clinical trial 06-196 in which the participants own CLL cells may form part of a vaccine treatment for their leukemia. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1 129 http://clinicaltrials.dfhcc.harvard.edu/trials/129 Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-Cells in Patients With Relapsed Hematologic Malignancies The purpose of this research study is to evaluate the safety and efficacy of cell depletion in a donor lymphocyte infusion (DLI) product with the use of the CliniMACS machine. Previously, patients with hematologic malignancies who have relapsed after transplant have been given infusions of donor white blood cells calsed donor lymphocyte infusion (DLI) as a way to boost their immune function and fight cancer. Information from other research studies suggests that lowering the number of a certain type of white blood cell called CD25+ Tregs in the DLI may allow for a greater effect. In this research study, we are looking for the appropriate dose of DLI depleted of the CD25+ Treg white blood cells that can be given safely. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds 14 Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/14-hodgkin-s-lymphoma 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma Phase 1 131 http://clinicaltrials.dfhcc.harvard.edu/trials/131 Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL) The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1 161 http://clinicaltrials.dfhcc.harvard.edu/trials/161 Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination The purpose of this research study is to assess the safety and immune activity of a vaccine made from the participant's own cancer cells, when administered after a reduced intensity transplant. In recent years, researchers at Dana-Farber Cancer Institute have discovered that vaccines made from a patients's own cancer cells, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1 193 http://clinicaltrials.dfhcc.harvard.edu/trials/193 Obatoclax, Fludarabine, and Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia RATIONALE: Obatoclax may stop the growth of chronic lymphocytic leukemia by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving obatoclax together with fludarabine and rituximab may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of obatoclax when given together with fludarabine and rituximab in treating patients with B-cell chronic lymphocytic leukemia. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1