Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation
Chronic Myeloid LeukemiaMyelodysplastic Syndrome1 moreAllogeneic hematopoietic stem cell transplantation (HSCT) is an established form of treatment for hematological abnormalities. Poor graft function, occurs when there poor donor engraftment. A second infusion of unselected donor hematopoietic stem cells (HSC) can result in improvement, but can potentially increase the incidence of graft versus host disease. Cluster of differentiation 34+ (CD34+) selected stem cells depleted of T-cells is an attractive alternative for treatment of poor graft function as it may be associated with less Graft versus Host Disease (GVHD) and enhanced count recovery. The investigators are using the Miltenyi CliniMACS device and CD34 cell selection reagents for the preparation of allogeneic hematopoietic progenitor cell (HPC) transplants for patients who have had prior stem cell transplants and require a stem cell "boost" from the original donor.
Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients...
CD33 Positive Acute Myelogenous LeukemiaAn expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA. Contact: B1761026@iconplc.com
Managed Access Program (MAP)* to Provide Access to Asciminib for Patients With CML in Chronic Phase...
Chronic Myeloid LeukemiaThis program provides access to asciminib for patients with CML in chronic phase (CP) without documented T315I mutation after failure to or intolerance of two prior TKI OR patients in CML-CP with documented T315I mutation and without comparable or satisfactory alternative therapy to treat the disease
Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic...
Chronic Myeloid LeukemiaThis study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia who are resistant or intolerant to imatinib and to provide patients access to this new drug until the drug becomes commercially available.
Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3...
Acute Myeloid Leukemia (AML)FMS-like Tyrosine Kinase-3 (FLT3) MutationsThe purpose of this study is to provide expanded access to gilteritinib (ASP2215) for patients with FMS-like tyrosine kinase 3 (FLT3)-mutated relapsed or refractory acute myeloid leukemia (AML) or with FLT3-mutated AML in composite complete remission (CRc: [complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission with incomplete platelet recovery (CRp)]) with minimal residual disease (MRD) without access to comparable or alternative therapy.
Expanded Access for CC-486
Acute Myelogenous Leukemia (AML)This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.
Flotetuzumab Expanded Access Program
Acute Myeloid LeukemiaAML2 moreThe purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.
Expanded Access Protocol (EAP) Using the CliniMACS® Device for Pediatric Haplocompatible Donor Stem...
Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia10 moreThis protocol provides expanded access to bone marrow transplants for children who lack a histocompatible (tissue matched) stem cell or bone marrow donor when an alternative donor (unrelated donor or half-matched related donor) is available to donate. In this procedure, some of the blood forming cells (the stem cells) are collected from the blood of a partially human leukocyte antigen (HLA) matched (haploidentical) donor and are transplanted into the patient (the recipient) after administration of a "conditioning regimen". A conditioning regimen consists of chemotherapy and sometimes radiation to the entire body (total body irradiation, or TBI), which is meant to destroy the cancer cells and suppress the recipient's immune system to allow the transplanted cells to take (grow). A major problem after a transplant from an alternative donor is increased risk of Graft-versus-Host Disease (GVHD), which occurs when donor T cells (white blood cells that are involved with the body's immune response) attack other tissues or organs like the skin, liver and intestines of the transplant recipient. In this study, stem cells that are obtained from a partially-matched donor will be highly purified using the investigational CliniMACS® stem cell selection device in an effort to achieve specific T cell target values. The primary aim of the study is to help improve overall survival with haploidentical stem cell transplant in a high risk patient population by limiting the complication of GVHD.
NGS in AML Relapse
Acute Myeloid LeukemiaAcute myeloid leukemia (AML) relapse is often associated with a clonal evolution at the cytogenetic and molecular level and therefore represents a challenge in the treatment of AML. Targeted sequencing is now usually done at diagnosis in AML, as only a small core group of genes is frequently mutated in AML and myelodysplastic syndromes. This approach, contrary to WGS is cheaper, together with a rapid turnaround and high sequencing coverage depths allowing the detection of variant allele fractions as low as 2%. In the investigator's center, targeted analysis of AML patients is routinely realized at diagnosis and at relapse. In thses patients, five different clonal evolution patterns including cytogenetic and molecular analysis at relapse will be evaluated: (1) Stability, defined by no clonal change, (2) Gain, strictly defined by acquisition of additional variations (mutations or cytogenetic alterations), (3) Loss, strictly defined by loss of variants or regression, (4) Gain and Loss, indicating the combination of both Gain and Loss patterns, (5) Emergence, defined by the emergence of alterations that were unrelated to those found at diagnosis. Karyotype and the mutations of up to 40 AML patients benefited from targeted NGS in the clinical hematology laboratory of the Hopitaux Universitaires de Strasbourg both at the time of the diagnosis of and the relapse will be studied, together with clinical and other biological characteristics.
Screening of IDH1 and IDH2 Gene Mutations in Adult Acute Myeloid Leukemia for Possible Targeted...
Acute Myeloid LeukemiaTo assess the incidence of IDH1 and IDH2 mutations in adult AML patients, and to explore their associations with the patients' clinical, cytogenetic, and molecular characteristics as well as with treatment response and outcome. To delineate the similarities and distinctions among mutations at IDH1-R132, IDH2-R140 and IDH2-R172 in AML, both clinically and molecularly (including cytogenetics, immunophenotyping, mutation co-occurrence patterns). The results can be references for future selection of targeted therapy (targeting IDH mutant proteins).