Umbilical Cord Blood Stem Cell Transplantation in Adults With Advanced Blood Disorders or Cancer...
Hematologic NeoplasmsUmbilical cord blood is an important source of stem cells and can be used to treat blood and immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord blood have been shown to be effective in treating illness in children, but more research is needed to confirm the benefit of this procedure in adults. The purpose of this study is to examine the immune system response to cord blood stem cell transplantation in adults with advanced blood disorders or cancer.
Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced...
Hematologic NeoplasmsThe primary objective of this study is to determine the recommended dose of CPX-351 for use in a phase 2 efficacy study in patients with leukemia. Secondarily, the study will assess the safety, serious adverse effects and how the body handles CPX-351. Preliminary evidence of antitumor activity will also be determined.
Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
Hematological MalignancyBone Marrow Failure SyndromeTo determine the time to and rate of hematologic engraftment following unrelated umbilical cord blood transplantation in adults with one or two cord blood units using total body irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis.
Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer
Hematologic NeoplasmsProstatic NeoplasmsThe purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma.
Sorafenib in Combination With Cytarabine and Clofarabine in Patients With Refractory or Relapsed...
Acute Myeloid LeukemiaInfantile Leukemia (Both AML and ALL)3 moreThis is a Phase I study that determines a tolerable combination of sorafenib, when given sequentially with cytarabine and clofarabine and determines the feasibility of administering this drug combination in patients with relapsed or refractory hematologic malignancies including acute myeloid leukemia (AML), acute promyelocytic leukemia (APL), acute lymphoblastic leukemia (ALL), infantile leukemia (both either AML and/or ALL). AML with prior myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasms, and biphenotypic leukemia.
A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in...
AllograftAllogeneic Cell Transplantaion2 moreThis study is a prospective comparison between 2 popular regimens based on reduced intensity or non-myeloablative approaches to define the optimal myeloablative and/or immu-nonsuppressive association for reduced intensity conditionings (RIC). Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2 days) and Thymoglobuline (2.5 mg/m²/1day). Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation (TBI). A randomization of 2 phase study according to the methodology developed by Liu et al (Liu, 1993 and 2001) for the evaluation of multiple innovative approaches. Primary endpoint is one year overall survival (OS). Stopping rules included excessive engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an independent safety review board (ISRB). Inclusion criteria are patients presenting a hematological malignancy, eligible for non myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable HLA identical sibling. All patients and donors are included after giving written informed consent. Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular therapies committee (national agency).
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?
Hematological DiseasesHematological Malignancies4 moreThe purpose of this study is to determine whether treatment with Bismuth can reduce the toxicity of chemotherapy and radiotherapy in patients with malignant diseases of the blood.
Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia
Hematopoietic NeoplasmPrimary Objective: Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for : Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months in patients with polycythemia vera, and Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients with essential thrombocythemia. PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for: Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with PV, and Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with ET. Secondary Objectives: To evaluate the safety of SAR302503. To evaluate the efficacy of SAR302503 in patients with PV who are resistant or intolerant to hydroxyurea for inducing absence of phlebotomy eligibility. To evaluate the efficacy of SAR302503 in patients with ET who are resistant or intolerant to hydroxyurea for reduction of platelet counts. To evaluate the efficacy of SAR302503 in inducing complete and partial responses beginning at Day 1 of Cycle 6 visit through Cycle 8. To evaluate splenic response as measured by spleen volume using MRI or CT. To evaluate the pharmacokinetics of SAR302503 after single and repeat doses. To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition. To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated symptoms, as well as overall impact on quality of life. To measure generic health-related quality of life and utility value using the EuroQol Group (EQ-5DTM) questionnaire.
TLI & ATG for Non-Myeloablative Allogeneic Transplantation for MDS and MPD
Myeloproliferative DisordersBlood Cancer1 moreTo evaluate the feasibility and safety of TLI/ATG conditioning for allogeneic HCT for elderly patients with advanced stage MDS and MPD.
Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies
Acute DiseaseMyelodysplastic Syndromes7 moreThe purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).