Text Size

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

This study is currently recruiting participants.
Verified March 2011 by University of Cologne
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01283776
First received: January 25, 2011
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Multiple Myeloma
Non-Hodgkin-Lymphoma
Hodgkin's Disease
 Drug: Cyclophosphamide
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Number of patients not requiring additional immunosuppression [ Time Frame: day 100 after transplant ] [ Designated as safety issue: Yes ]
    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:
  • Overall Survival [ Time Frame: day 100 after transplant ] [ Designated as safety issue: Yes ]
  • engraftment [ Time Frame: day 100 after transplant ] [ Designated as safety issue: Yes ]
    absolute neutrophil count of > 0.5 x 10e9/l on 3 consecutive days

  • chimerism [ Time Frame: day 100 after transplant ] [ Designated as safety issue: Yes ]
    Percentage of donor cells in leukocytes from peripheral blood or bone marrow

  • relapse incidence [ Time Frame: day 100 after transplant ] [ Designated as safety issue: No ]
    cumulative incidence of relapse until day 100

  • acute GvHD [ Time Frame: day 100 after transplant ] [ Designated as safety issue: Yes ]
    cumulative incidence of acute GvHD

  • non-relapse mortality [ Time Frame: day 100 after transplant ] [ Designated as safety issue: Yes ]
    cumulative incidence of death from any cause without prior relapse or progression of malignant disease

  • immune reconstitution [ Time Frame: day 100 after transplant ] [ Designated as safety issue: No ]
    relative and absolute counts of B- and T-lymphocyte subsets in peripheral blood


Estimated Enrollment: 11
Study Start Date: March 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment arm
Cyclophosphamide
 Drug: Cyclophosphamide
100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283776

Contacts
Contact: Christoph Scheid, MD PhD 49221478 ext 6296 c.scheid@uni-koeln.de

Locations
Germany
University of Cologne Recruiting
Cologne, Germany, 50924
Contact: Christoph Scheid, MD PhD     49221478 ext 6296     c.scheid@uni-koeln.de    
Sub-Investigator: Udo Holtick, MD            
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Christoph Scheid, MD PhD University of Cologne
  More Information

No publications provided

Responsible Party: Christoph Scheid, Principal Investigator, University of Cologne
ClinicalTrials.gov Identifier: NCT01283776     History of Changes
Other Study ID Numbers: Uni-Koeln-1430
Study First Received: January 25, 2011
Last Updated: March 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 26, 2012