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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Non-Hodgkin-Lymphoma Hodgkin's Disease Drug: Cyclophosphamide Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Study to Investigate the Efficacy of Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation
Study Start Date : March 2011
Primary Completion Date : December 2013
Study Completion Date : June 2014

Arms and Interventions

Arm Intervention/treatment
Experimental: treatment arm
Drug: Cyclophosphamide
100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: day 100 after transplant ]
  2. engraftment [ Time Frame: day 100 after transplant ]
    absolute neutrophil count of > 0.5 x 10e9/l on 3 consecutive days

  3. chimerism [ Time Frame: day 100 after transplant ]
    Percentage of donor cells in leukocytes from peripheral blood or bone marrow

  4. relapse incidence [ Time Frame: day 100 after transplant ]
    cumulative incidence of relapse until day 100

  5. acute GvHD [ Time Frame: day 100 after transplant ]
    cumulative incidence of acute GvHD

  6. non-relapse mortality [ Time Frame: day 100 after transplant ]
    cumulative incidence of death from any cause without prior relapse or progression of malignant disease

  7. immune reconstitution [ Time Frame: day 100 after transplant ]
    relative and absolute counts of B- and T-lymphocyte subsets in peripheral blood

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283776

University of Cologne
Cologne, Germany, 50924
Sponsors and Collaborators
University of Cologne
Principal Investigator: Christoph Scheid, MD PhD University of Cologne
More Information

Responsible Party: Christoph Scheid, PD Dr. Christoph Scheid, University of Cologne
ClinicalTrials.gov Identifier: NCT01283776     History of Changes
Other Study ID Numbers: Uni-Koeln-1430
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Multiple Myeloma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists