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

Phase 2

Completed

• Conditions: Multiple Myeloma; Non-Hodgkin-Lymphoma; Hodgkin's Disease
• Interventions: Drug: Cyclophosphamide

• Registration Number: NCT01283776
• Lead Sponsor: University of Cologne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Study Start: 2011-03
• Primary Completion: 2013-12
• Status Verified: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-08
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	Cyclophosphamide	Cyclophosphamide

Primary Outcome Measures

Name	Time	Method
Number of patients not requiring additional immunosuppression	day 100 after transplant	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	day 100 after transplant
immune reconstitution	day 100 after transplant	relative and absolute counts of B- and T-lymphocyte subsets in peripheral blood
engraftment	day 100 after transplant	absolute neutrophil count of \> 0.5 x 10e9/l on 3 consecutive days
chimerism	day 100 after transplant	Percentage of donor cells in leukocytes from peripheral blood or bone marrow
acute GvHD	day 100 after transplant	cumulative incidence of acute GvHD
non-relapse mortality	day 100 after transplant	cumulative incidence of death from any cause without prior relapse or progression of malignant disease
relapse incidence	day 100 after transplant	cumulative incidence of relapse until day 100

Trial Locations

Locations (1)

University of Cologne; 🇩🇪 Cologne, Germany