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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study to Investigate the Efficacy of Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation

Conditions
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Multiple Myeloma, Non-Hodgkin-Lymphoma, Hodgkin's Disease

Intervention / Treatment
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* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>Cyclophosphamide | Drug: Cyclophosphamide<br>* 100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | day 100 after transplant | 

Secondary Outcome Measures

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