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

Primary Purpose

Multiple Myeloma, Non-Hodgkin-Lymphoma, Hodgkin's Disease

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Cyclophosphamide

About this trial

This is an interventional prevention trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Cologne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

Cyclophosphamide

Outcomes

Primary Outcome Measures

Number of patients not requiring additional immunosuppression

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

engraftment

absolute neutrophil count of > 0.5 x 10e9/l on 3 consecutive days

chimerism

Percentage of donor cells in leukocytes from peripheral blood or bone marrow

relapse incidence

cumulative incidence of relapse until day 100

acute GvHD

cumulative incidence of acute GvHD

non-relapse mortality

cumulative incidence of death from any cause without prior relapse or progression of malignant disease

immune reconstitution

relative and absolute counts of B- and T-lymphocyte subsets in peripheral blood

Full Information

NCT ID

NCT01283776

First Posted

January 25, 2011

Last Updated

June 8, 2014

Sponsor

University of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT01283776

Brief Title

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

Acronym

OCTET-CY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cologne

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma, Non-Hodgkin-Lymphoma, Hodgkin's Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treatment arm

Arm Type

Experimental

Arm Description

Cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients not requiring additional immunosuppression

Description

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

Time Frame

day 100 after transplant

Secondary Outcome Measure Information:

Title

Overall Survival

Time Frame

day 100 after transplant

Title

engraftment

Description

absolute neutrophil count of > 0.5 x 10e9/l on 3 consecutive days

Time Frame

day 100 after transplant

Title

chimerism

Description

Percentage of donor cells in leukocytes from peripheral blood or bone marrow

Time Frame

day 100 after transplant

Title

relapse incidence

Description

cumulative incidence of relapse until day 100

Time Frame

day 100 after transplant

Title

acute GvHD

Description

cumulative incidence of acute GvHD

Time Frame

day 100 after transplant

Title

non-relapse mortality

Description

cumulative incidence of death from any cause without prior relapse or progression of malignant disease

Time Frame

day 100 after transplant

Title

immune reconstitution

Description

relative and absolute counts of B- and T-lymphocyte subsets in peripheral blood

Time Frame

day 100 after transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Scheid, MD PhD

Organizational Affiliation

University of Cologne

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cologne

City

Cologne

ZIP/Postal Code

50924

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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