Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

IV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood

POL6326

Hartmut Goldschmidt, MD

The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation

Exploratory Study on POL6326 in Stem Cell Mobilization

A Phase IIa, Proof of Concept Study is to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients With Multiple Myeloma

Number of patients achieving the minimal number of CD34+ cells (≥2 x 10 mill/kg BW) collected during one to four cycles of apheresis which are considered necessary and safe to proceed with autotransplantation

Number of apheresis cycles required to obtain the minimal number of CD34+ cells necessary for autotransplantation (≥2 x 10 mill/kg BW)

Polyphor Ltd.

Symptoms and General Pathology

Syndrome

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Hodgkin Disease

Myeloproliferative Disorders

Preleukemia

Myelodysplastic Syndromes

Lymphoma, Non-Hodgkin

Lymphatic Diseases

Bone Marrow Diseases

Precancerous Conditions

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Lymphosarcoma

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

On Day 1 (and possibly Day 2) POL6326 IV Infusion with increasing dose levels in Phase I or with random dose assignment (from the 2 selected from Phase I) in phase II

Leukapheresis collection on Day 1 (and possibly Day 2)

Day 0 - PBSC transplant with stem cells mobilized with IV POL6326

Leukapheresis

PBSC Transplant

Daniel Couriel, M.D.

Determine the safety and tolerability of POL6326 when used as a single mobilization agent.

Current protocols use G-CSF to mobilize hematopoietic progenitor cells from matched sibling donors. This process requires from four to six days of G-CSF injection and is associated with significant morbidity, most notably bone pain. POL6326 is associated with few side effects and collection of cells occurs on the same day as POL6326 administration.

This study will evaluate the safety and efficacy of this novel agent for hematopoietic progenitor cell mobilization and allogeneic transplantation based on the following hypotheses:

1. Donors mobilized with intravenous POL6326 will require fewer collections than have previously been seen for donors mobilized with subcutaneous plerixafor.
2. Healthy HLA-matched donors receiving one or two infusions of POL6326 will mobilize sufficient CD34+ cells (at least 2.0 x 106 CD34+ cells/kg recipient weights) following leukapheresis to support a hematopoietic cell transplant.
3. IV POL6326 will result in more rapid kinetics and a higher maximum (peak) of human CD34+ stem cells mobilized from human normal allogeneic donors compared to previous donors who were mobilized with plerixafor.
4. The hematopoietic cells mobilized by IV POL6326 will be functional and will result in prompt and durable hematopoietic engraftment following transplantation into HLA-identical siblings with advanced hematological malignancies using various non-myeloablative and myeloablative conditioning regimens and regimens for routine GVHD prophylaxis.

Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic Malignancies

A Phase I/II Study Evaluating the Safety and Efficacy of Intravenous POL6326 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies

Determine the number of allogeneic donors which collect \>= 2 mill CD34+ cells with one or two leukapheresis procedures treated with IV POL6326. Comparison with historic group of donors who were mobilized with 240 µg/kg SC plerixafor.

To estimate the proportion of HLA-identical sibling donors who experience grade 3-4 infusional toxicity and the proportion from whom \> 2 mill CD34+ cells/kg recipient weight are safely mobilized following one or two leukapheresis procedures

Acute GVHD - Day 100 (+/- 7 days) Chronic GVHD - Day 365 (+/- 14 days)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exploratory Study on POL6326 in Stem Cell Mobilization	NCT01105403	Multiple Myelom...	POL6326	18 Years - 70 Years	Polyphor Ltd.
Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic Malignancies	NCT01413568	Acute Myeloid L... Adult Acute Lym... Chronic Myeloge... Non-Hodgkin's L... Chronic Lymphoc... Multiple Myelom... Myelodysplastic... Myeloproliferat...	POL6326 Leukapheresis PBSC Transplant	18 Years - 75 Years	Polyphor Ltd.

Spots Global Cancer Trial Database for pol6326

Every month we try and update this database with for pol6326 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pol6326

Every month we try and update this database with for pol6326 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pol6326 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.