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Leukemia/MDS Clinical Trials

Showing 1-30 of 33 items
  • Double Cord Versus Haploidentical (BMT CTN 1101)
  • Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow; and, one that uses two partially matched cord blood units.
  • Diagnoses: Leukemia/MDS, Hodgkin's Lymphoma
  • Status: Recruiting
  • Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
  • This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy 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. Monoclonal antibodies, such as blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML
  • This research study is studying a targeted therapy (a form of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells) as a possible treatment for high-risk acute myeloid leukemia. The names of the study interventions involved in this study are: - Alisertib / MLN8237 - Cytarabine / Cytosine Arabinoside - Idarubicin / Idarubicin hydrochloride - Daunorubicin (Can be used in place of idarubicin)
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • Reduced Intensity Double Umbilical Cord Blood Transplantation
  • This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • A Phase 2 Study Of PRM-151 In Subjects With Myelofibrosis
  • PRM-151 is an investigational drug that is being developed for possible use in the treatment of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body that makes blood cells, is replaced by fibrosis, or excess scar tissue. The purpose of this study is to gather information on whether PRM-151 has an effect on the MF disease, whether it is safe in patients with MF, and how well it is tolerated.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • Busulfan/Clofarabine + Allogeneic Stem Cell Transplantation
  • This research is a phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational intervention to learn whether it works in treating a specific cancer. "Investigational" means that the study intervention is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved this study intervention for your type of cancer. All participants on this study are treated in an identical manner. The investigators are doing this study because there continues to be a significant risk of relapse of disease after reduced intensity transplantation. In studies which have compared transplants using high-doses of chemotherapy and/or radiation versus reduced intensity transplants, patients undergoing reduced intensity transplants appear to have higher rates of relapse, but lower rates of toxicity and complication. This study attempts to utilize clofarabine, a newer chemotherapy agent shown to be quite active in AML, ALL, and MDS, to increase the anti-tumor effects of the conditioning regimen without accumulating unacceptable toxicity. The reduced intensity allogeneic stem cell transplantation procedure involves giving you chemotherapy in relatively less intense doses to suppress your immune system. This is followed by an infusion of healthy blood stem cells from a matched related donor or a matched unrelated volunteer donor. It is hoped that these donor cells can eventually then attack any cancer cells which remain. In this research study, the investigators are looking to see how well this new combination of busulfan and clofarabine works in reduced intensity allogeneic stem cell transplantation. By "works" the investigators mean to analyze safety, ability of donor cells to engraft (take hold), as well as measures of complications including toxicity, infections, graft-vs-host disease (GVHD), and relapse.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • Pyrimethamine for the Treatment of Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • In this research study we will start by looking for the highest dose of pyrimethamine that can be given safely to CLL patients without severe or unmanageable side effects. This dose will then be used for a larger Phase II study to assess the efficacy of pyrimethamine for the treatment of CLL/SLL. Pyrimethamine is an antibiotic that is used for the treatment of certain infections. Previous research studies have shown that pyrimethamine may target a protein in tumor cells, called STAT3, which may be important for the growth of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) cells. Pyrimethamine can kill CLL/SLL cells in the laboratory, and we are therefore undertaking this study to assess whether pyrimethamine will result in clinical benefit or tumor responses in CLL in patients.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission
  • This is a non-randomized open label multi-center study. Patients who are in their first complete remission (CR) following induction therapy will be treated with SL-401, which will be administered as a brief intravenous infusion for 5 consecutive days every 28 days for 6 or more cycles. Stage 1 will consist of a period in which approximately 6-9 patients will be treated with SL-401 at 3 dose levels. During Stage 2, approximately 24-29 patients with minimal residual disease (MRD) in their bone marrow will be treated at a maximum tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage 1).
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • SL-401 in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia
  • This is a non-randomized, open-label, multi center study. A cycle of therapy is 5 consecutive days every 21 days for 6 or more cycles. Stage I will consist of a brief run-in period in which patients with BPDCN (previously untreated and previously treated) and AML (persistent/recurrent and previously untreated) will be treated with SL-401 at 3 dose levels. During Stage 2, two cohorts of BPDCN and AML patients will be treated at the maximum tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage 1).
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib
  • The purpose of this study is to find out if treating Chronic Myelomonocytic Leukemia (CMML) with a study drug [ruxolitinib] can improve outcomes of patients with CMML. The first step of the study is to learn the dose of ruxolitinib that is tolerable (bearable). It has already been studied in a number of patients with different bone marrow diseases and is approved for the treatment of a disease called Myelofibrosis; however, it is not approved for treatment of CMML. It is given orally (by mouth). Most people tolerate it well but the tolerability has not been determined in patients with CMML. We will be testing different doses to determine how much of the medication people can tolerate (bear) before they develop side effects.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • A Dose Escalation and Cohort Expansion Study of RO6870810/TEN-010 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
  • TEN-010 is a small molecule, bromodomain and extra-terminal domain (BET) bromodomain inhibitor. This study is designed to characterize the safety, tolerability, and pharmacokinetics of TEN-010 in patients with relapsed/refractory acute myeloid leukemia (RR-AML) and hypomethylating agent (HMA)-refractory myelodysplastic syndrome (MDS). In addition, this trial will assess response to treatment using International Working Group (IWG) response criteria. This study will be conducted in two parts: dose escalation and dose expansion. For dose escalation (Part A), a standard "3+3" design will be used in which successive cohorts of three or more patients with RR-AML or HMA-refractory MDS will be treated at escalating doses until a maximum tolerated dose (MTD) is identified. For the dose expansion part of the study (Part B), patients will be treated with TEN-010 at the MTD (or the highest dose tested if the MTD is not defined) to further characterize its safety, pharmacokinetics, and clinical response. A maximum of 68 patients aged 18 years or older with RR-AML or HMA-refractory MDS will be enrolled in the study. In part A, up to 18 adult patients will be enrolled. This includes up to 18 RR-AML or HMA-refractory MDS patients enrolled in 3 dose levels of up to 6 patients each. In part B, up to 50 patients with RR-AML and HMA-refractory MDS will be enrolled in separate study groups of up to 25 patients each.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • Phase 1/2 Study of AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation
  • Study AG221-C-001 is a Phase 1/2, multicenter, open-label, dose-escalation, safety, PK/PD, and clinical activity evaluation of orally administered AG-221 in subjects with advanced hematologic malignancies that harbor an IDH2 mutation. The study includes a dose escalation phase to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) and an expansion phase to further evaluate the safety, tolerability and clinical activity of AG-221 in select populations.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • A Phase I Study of Oral ABL001 in Patients With CML or Ph+ ALL
  • The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in CML and Ph+ ALL patients who are relapsed or refractory to or are intolerant of TKIs, and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
  • The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • Tipifarnib in Subjects With Transfusion-dependent, Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
  • This two-stage study is designed to investigate the antitumor activity of tipifarnib in approximately 58 eligible subjects with very low, low or INT risk MDS who have no known curative treatment. Eligible subjects may have received no more than 2 prior systemic therapies. In the first stage, 44 eligible subjects will be enrolled and stratified in to one of four biomarker-defined strata (11 subjects per stratum) based on subject KIR2DS2 and KIR2DL2 positivity. Subjects will receive tipifarnib administered at a starting dose of 900 mg, orally with food, twice a day (bid) for 7 days in alternating weeks (Days 1-7 and 15-21) in 28 day cycles. At the discretion of the investigator, the dose of tipifarnib may be increased to 1200 mg bid if the subject has not experienced dose limiting toxicities at the 900 mg dose level. Determination of RBC tranfusion independence and disease response will be performed by the Investigator according to the MDS/MPN International Working Group (IWG) criteria. Similarly, disease progression will also be determined based on the MDS/MPN IWG criteria.
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
  • Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia With an IDH1 and/or IDH2 Mutation
  • The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120 and AG-221 when given in combination with standard AML induction and consolidation therapy. The study plans to evaluate 1 dose level of AG-120 in patients with an IDH1 mutation and 2 dose levels of AG-221 in patients with an IDH2 mutation. AG-120 or AG-221 will be administered with 2 types of AML induction therapies (cytarabine with either daunorubicin or idarubicin) and 2 types of AML consolidation therapies (mitoxantrone with etoposide [ME] or cytarabine). After consolidation therapy, patients may continue on maintenance therapy and receive daily treatment of AG-120 or AG-221 for up to 1 year from Day 1 of the first induction cycle, or until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant (HSCT).
  • Diagnoses: Leukemia/MDS
  • Status: Recruiting
Showing 1-30 of 33 items
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