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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma, Non-Hodgkin-Lymphoma, Hodgkin's Disease

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of patients not requiring additional immunosuppression

Outcome Description:

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

Outcome Time Frame:

day 100 after transplant

Safety Issue:

Yes

Principal Investigator

Christoph Scheid, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cologne

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Uni-Koeln-1430

NCT ID:

NCT01283776

Start Date:

March 2011

Completion Date:

February 2012

Related Keywords:

  • Multiple Myeloma
  • Non-Hodgkin-Lymphoma
  • Hodgkin's Disease
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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