Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Syndrome

Lymphoma

Leukemia

Lymphoma, Non-Hodgkin

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hodgkin Disease

Myeloproliferative Disorders

Preleukemia

Myelodysplastic Syndromes

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bone Marrow Diseases

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Fludarabine

Fludarabine phosphate

Efficacy of MSC infusion on one-year overall survival of patients transplanted with HLA-mismatched PBSC.

Patients will receive a conditioning regimen consisting in fludarabine (total dose 90 mg/square meter) and 2 Gy total body irradiation.

MSC cells (1,5-3,0 x 10E6 MSC/Kg BW) will be injected, followed, at least one hour later, by the infusion of HLA-mismatched PBSC from related or unrelated donor.

Patients will receive a conditioning regimen consisting in fludarabine (total dose 90 mg/square meter) and 2Gy total body irradiation.

Isotonic solution will be injected will be injected, followed, at least one hour later, by the infusion of HLA-mismatched PBSC from related or unrelated donor.

Mesenchymal stem cells

Isotonic solution

Yves Beguin, MD, PhD

Frédéric Baron, MD, PhD

Evelyne Willems, MD

Dominik Selleslag, MD, PhD

Pierre Zachée, MD, PhD

Philippe Lewalle, MD, PhD

Dominique Bron, MD, PhD

Wilfried Schroyens, MD, PhD

Chantal Lechanteur, PhD

Etienne Baudoux, MD

Johan Maertens, MD

Rik Schots, MD, PhD

Augustin Ferrant, MD, PhD

Lucien Noens, MD, PhD

Chantal Doyen, MD, PhD

Tessa Kerre, MD, PhD

Carlos Graux, MD, PhD

The present project aims at evaluating the capacity of MSC to improve one-year overall survival of patients transplanted with HLA-mismatched PBSC from related or unrelated donors after non-myeloablative conditioning.

Co-infusion of MSC has been shown to facilitate engraftment of hematopoietic stem cell (HSC) in an immunodeficient mouse model. In addition, it has been shown that infusion of third party MSC in HSC transplantation could be successfully used as treatment for grade II-IV steroid-refractory acute graft versus host disease.

One hundred and twenty patients with HLA-mismatched donors will be included over 6 years at multiple centers across Belgium through the transplant committee of the Belgian Hematological Society. The conditioning regimen will consist of fludarabine and 2 Gy TBI, followed by the infusion of donor HSC. Patients will be randomized 1/1 in double-blind fashion to receive or not MSC (1.5-.3.0 x106/kg) from third-party (either haploidentical family members or unrelated volunteer) donors on day 0. Postgrafting immunosuppression will combine tacrolimus and MMF. Except for the collection, expansion and infusion of MSC, the clinical management of the patient will not differ from that of routine NM-HCT.

MSC and HSC Coinfusion in Mismatched Minitransplants

Co-transplantation of Mesenchymal Stem Cells and HLA-mismatched Allogeneic Hematopoietic Cells After Nonmyeloablative Conditioning: a Phase II Randomized Double-blind Study

AZ Sint-Jan AV

Ziekenhuis Netwerk Antwerpen (ZNA)

Jules Bordet Institute

Universiteit Antwerpen

AZ-VUB

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

University Hospital, Ghent

University of Liege

Prof

Myeloid Leukemia

Chronic Myeloid Leukemia

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.

This is a Phase II, exploratory, open-label study of the investigational product AG-858, in patients who are cytogenetically positive after treatment with Gleevec.

The trial will consist of three independent Phase II evaluations of patient groups according to their cytogenetic status as defined in the eligibility criteria (Eligibility Criteria 4a, 4b, and 4c).

The goals of this study are to determine the following:

* To estimate the proportion of patients with a complete cytogenetic response (CCR) within each patient group
* To estimate the proportion of patients with a substantial molecular response (SMR) within each patient group
* To evaluate the frequency and severity of adverse events.
* To assess the feasibility of AG-858 production.

AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™

Phase II Exploratory Study Of AG-858 Plus Gleevec™ In Patients With Chronic Myelogenous Leukemia (CML) In Chronic Phase Who Are Cytogenetically Positive After Treatment With Gleevec™

Agenus Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MSC and HSC Coinfusion in Mismatched Minitransplants	NCT01045382	Leukemia, Myelo... Leukemia, Lymph... Leukemia, Myelo... Myeloproliferat... Myelodysplastic... Multiple Myelom... Leukemia, Lymph... Hodgkin's Disea... Lymphoma, Non-H...	Mesenchymal ste... Isotonic soluti...	- 75 Years	University of Liege
AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™	NCT00058747	Leukemia, Myelo...	Autologous HSP-...	18 Years -	Agenus Inc.

Spots Global Cancer Trial Database for leukemia, myelocytic, chronic