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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by University of Cologne.
Recruitment status was Recruiting

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

Tracking Information

First Received Date ^ICMJE

January 25, 2011

Last Updated Date

March 15, 2011

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01283776 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Multiple Myeloma
Non-Hodgkin-Lymphoma
Hodgkin's Disease

Intervention ^ICMJE

Drug: Cyclophosphamide

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

Study Arm (s)

Experimental: treatment arm

Cyclophosphamide

Intervention: Drug: Cyclophosphamide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2012

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Christoph Scheid, MD PhD

49221478 ext 6296

c.scheid@uni-koeln.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01283776

Other Study ID Numbers ^ICMJE

Uni-Koeln-1430

Has Data Monitoring Committee

Responsible Party

Christoph Scheid, Principal Investigator, University of Cologne

Study Sponsor ^ICMJE

University of Cologne

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christoph Scheid, MD PhD

University of Cologne

Information Provided By

University of Cologne

Verification Date

March 2011

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

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