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

NCT ID: NCT01283776

Last Updated: 2014-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Multiple Myeloma Non-Hodgkin-Lymphoma Hodgkin's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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treatment arm

Cyclophosphamide

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

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

Interventions

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Cyclophosphamide

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Christoph Scheid

PD Dr. Christoph Scheid

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph Scheid, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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University of Cologne

Cologne, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Uni-Koeln-1430

Identifier Type: -

Identifier Source: org_study_id

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