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Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation (OCTET-CY)

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ClinicalTrials.gov Identifier: NCT01283776
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : June 10, 2014
Sponsor:
Information provided by (Responsible Party):

January 25, 2011
January 26, 2011
June 10, 2014
March 2011
December 2013   (Final data collection date for primary outcome measure)
Number of patients not requiring additional immunosuppression [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01283776 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: day 100 after transplant ]
  • engraftment [ Time Frame: day 100 after transplant ]
    absolute neutrophil count of > 0.5 x 10e9/l on 3 consecutive days
  • chimerism [ Time Frame: day 100 after transplant ]
    Percentage of donor cells in leukocytes from peripheral blood or bone marrow
  • relapse incidence [ Time Frame: day 100 after transplant ]
    cumulative incidence of relapse until day 100
  • acute GvHD [ Time Frame: day 100 after transplant ]
    cumulative incidence of acute GvHD
  • non-relapse mortality [ Time Frame: day 100 after transplant ]
    cumulative incidence of death from any cause without prior relapse or progression of malignant disease
  • immune reconstitution [ Time Frame: day 100 after transplant ]
    relative and absolute counts of B- and T-lymphocyte subsets in peripheral blood
Same as current
Not Provided
Not Provided
 
Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation
A Phase II Study to Investigate the Efficacy of Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Multiple Myeloma
  • Non-Hodgkin-Lymphoma
  • Hodgkin's Disease
Drug: Cyclophosphamide
100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation
Experimental: treatment arm
Cyclophosphamide
Intervention: Drug: Cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
June 2014
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01283776
Uni-Koeln-1430
No
Not Provided
Not Provided
Christoph Scheid, University of Cologne
University of Cologne
Not Provided
Principal Investigator: Christoph Scheid, MD PhD University of Cologne
University of Cologne
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP