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NCT Number: NCT01283776

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Hodgkin's Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non-Hodgkin-Lymphoma Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Cologne

Cologne, 50924, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Acronym: OCTET-CY

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 26, 2011
Registry last updated
Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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