Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants...
LymphomaMyeloma5 moreResults to date of umbilical cord blood transplantation in adult and fully mature adolescent patients are inferior to what is seen in children, due to a lower stem cell dosage in adults and a more toxic conditioning regimen. This phase 1 protocol will use a potentially less toxic bone marrow conditioning regimen, followed by infusion of a combined umbilical cord blood graft that will provide the patient with a higher stem cell dose than can be given with a single umbilical cord blood infusion. The subjects will be conditioned with a total body irradiation (TBI) 13.5 Gy and fludarabine. Following conditioning, up to two unrelated, partially matched umbilical cord blood grafts will be infused that will provide a minimum nucleated cell dose of 3 x 10e7/kg . The primary objective of this study is to measure the frequency of treatment-related toxicity and engraftment.
A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
Myelodysplastic SyndromeThe purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.
Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
Myelodysplastic SyndromesThis is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.
Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients With High Risk Leukemia and Myelodysplasia...
LeukemiaMyelodysplasia2 moreUnrelated Cord Blood (UCB) transplant in children is a viable stem cell transplant modality for patients with leukemia and myelodysplasia. UCB is now considered "Standard Of Care" in cases where a suitable living bone marrow donor is not available. The survival of UCB is similar to Matched Unrelated Marrow Transplant. This study is considered "Research" since UCB is not a licensed product and requires investigational new drug (IND). THERE ARE NO SPECIFIC RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem cell treatment modality to pediatric patients who may require it after a conditioning regimen that excludes Total Body Irradiation.
Allo HSCT Using RIC for Hematological Diseases
Acute Myelogenous LeukemiaAcute Lymphocytic Leukemia16 moreThis is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion. The primary objective is to evaluate rates of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with hematologic malignancies.
Unrelated Donor Stem Cell Transplantation
Severe Aplastic AnemiaParoxysmal Nocturnal Hemoglobinuria11 moreThe purpose of this study is to provide an opportunity for patients with malignancies or bone marrow failure states who lack a suitable sibling donor to undergo allogeneic hematopoietic progenitor cell transplantation using cells from unrelated individuals or cord blood registries.
A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low-...
Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS)The purpose of this study is to assess pharmacokinetic and pharmacodynamic characteristics of oral lenalidomide monotherapy administered to patients with Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS).
Busulfan Plus Cyclophosphamide vs Fludarabine as a Conditioning Regimen
LeukemiaMyelodysplastic SyndromeAt the same time of registration, patients will be randomized to one of the two conditioning therapy groups; Arm I (intravenous busulfan plus cyclophosphamide; BuCy) or Arm II (intravenous busulfan plus fludarabine; BuFlu). Randomization will be a stratified permuted-block design. 2.1The patients will be stratified into standard risk vs. high risk group, and related vs. unrelated donor. Standard risk group will be defined as follows: patients with acute leukemia in first remission, CML in chronic phase, and MDS (RA or RARS categories). High risk group will be defined as follows: patients with acute leukemia in relapse or in second or subsequent remission, CML in accelerated or blastic phase, and MDS (CMMoL or RAEB categories). 2.2.Pre-assigned block size is 8.
Treosulfan-based Conditioning for Transplantation in AML/MDS
Acute Myeloid LeukemiaMyelodysplastic SyndromeThe study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan, will reduce toxicity after allogeneic transplantation while improving myeloablation and and disease control in patients with AML and MDS not eligible for standard transplantation.
Dose Escalation and Proof-of-Concept Studies of Vactosertib (TEW-7197) Monotherapy in Patients With...
Myelodysplastic SyndromesThis is a prospective, open-label, multicenter, phase 1/2 study of TEW-7197 in patients with low and intermediate risk of myelodysplastic syndrome (MDS).