Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation

University of Cologne11 enrolled

Overview

A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Multiple Myeloma Non-Hodgkin-Lymphoma Hodgkin's Disease

Interventions

CyclophosphamideDRUG

100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkin's disease after allogeneic stem cell transplantation with reduced intensity conditioning * Written informed consent * No uncontrolled infections Exclusion Criteria: * Severe organ dysfunction defined as: * Cardiac left ventricular ejection fraction (LVEF) of less than 35% * diffusing lung capacity (DLCO) of less than 40% * total lung capacity (TLC) of less than 40% * forced expiratory volume (FEV1) of less than 40% * total bilirubin \>3mg/dl * creatinine-clearance of less than 40 ml/min * pregnancy or breast feeding * participation in other experimental drug trials

Locations (1)

University of Cologne

Cologne, Germany

Outcomes

Primary Outcomes

Number of patients not requiring additional immunosuppression

The primary endpoint is met if at least 1 of the 5 first patients and 3 of a total of 11 patient will reach day 100 after transplant without additional immunsuppressive drug treatment