Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis Af... | NCT01283776

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

NCT01283776

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Jun 10, 2014Estimated

Enrollment

11Actual

Phase

Phase 2

Conditions

Multiple Myeloma
Non-Hodgkin-Lymphoma
Hodgkin's Disease

Interventions

Cyclophosphamide

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jan 25, 2011

First Submission Date that Met QC Criteria

Jan 25, 2011

First Posted Date

Jan 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2014

Last Update Posted Date

Jun 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment arm	Experimental	Cyclophosphamide	Drug: Cyclophosphamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclophosphamide	Drug	100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation	treatment arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	day 100 after transplant

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival		day 100 after transplant
engraftment	absolute neutrophil count of > 0.5 x 10e9/l on 3 consecutive days	day 100 after transplant

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christoph Scheid, MD PhD	University of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cologne		Cologne		50924	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma
D008228	Lymphoma, Non-Hodgkin
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003520	Cyclophosphamide

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Browse Leaves

Not provided

Browse Branches

Not provided