Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Leukemia

Leukemia, Lymphoid

Hematologic Neoplasms

Hodgkin Disease

Hematologic Diseases

Lymphosarcoma

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Romiplostim at the assigned dose will be administered subcutaneously (SQ) once a week for 6 weeks (i.e. 6 doses) unless platelet count exceeds 100 x 10\^9/L and at least 4 doses of therapy were given.After the initial dose, subsequent doses will be administered within a window of +/- 3 days.

Romiplostim at the assigned dose will be administered subcutaneously (SQ) once a week for 6 weeks. The dose will be assigned at the time of subject registration. This is a dose escalation to determine the maximum tolerated dose. The doses include 4 mcg/kg/dose, 6 mcg/kg/dose, 8 mcg/kg/dose, and 10 mcg/kg/dose.

Romiplostim

Margaret MacMillan, MD, MSc, FRCPC

This is a single institution, phase I dose escalation study of weekly romiplostim post umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8, and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20% or less.

Safety of Romiplostim (Nplate®) Following UCBT

Safety of Romiplostim (Nplate®) in Patients Who Have Failed to Achieve Platelet Engraftment Following Umbilical Cord Blood Transplant

Measured by number of patients who have failed to achieve platelet engraftment by day +28 after a myeloablative or nonmyeloablative umbilical cord blood transplant (UCBT)

Average speed of platelet recovery in patients who have failed to achieve platelet engraftment.

Incidence of clinically significant bleeding episodes and number of platelet transfusions.

Masonic Cancer Center, University of Minnesota

Neoplasms by Histologic Type

Administration of 20 fraction of the UCBT

DLI of the 20 fraction of the UCBT

Sergio Querol, PhD

Pilot, multicentric, open-label, single-arm, phase I-II clinical trial to evaluate the safety and efficacy of a novel Umbilical Cord Blood Transplantation (UCBT) platform, that consists of a UCBT of the 80 fraction, followed by a Donor Lymphocyte Infusion (DLI) of the 20 fraction (between 60 and 90 days after transplantation).

Multicenter, open-label, single-arm, phase I-II pilot study in which a minimum of 20 patients will enter the study with the primary objective to assess the safety and secondary objective to assess efficacy in relation to immune reconstitution followed by a new platform of treatment consisting of initial cord blood unit 80 fraction transplantation, followed by a prophylactic donor lymphocyte infusion (DLI) of the fraction 20 of the cord blood unit. The second infusion will take place between 60 and 90 days after transplantation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety of Romiplostim (Nplate®) Following UCBT	NCT02046291	Hematologic Mal...	Romiplostim	18 Years -	Masonic Cancer Center, University of Minnesota
Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation	NCT02328885	Leukemia	DLI of the 20 f...	- 60 Years	Banc de Sang i Teixits

Spots Global Cancer Trial Database for ucbt

Every month we try and update this database with for ucbt 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 ucbt

Every month we try and update this database with for ucbt 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 ucbt 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.