Search for Predictive Markers of Efficacy of ESAs in Pati... | NCT01546337

Studies
Search for Predictive Markers of Efficacy of ESAs in Patients With Non-myeloid Malignancies or Myelodysplastic Syndrome

NCT01546337

Sponsor

Rennes University Hospital

Status

Terminated

Last Update Posted

Mar 7, 2012Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Myelodysplastic Syndromes
Anemia
Hemopathies

Interventions

Not provided

Countries

France

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

May 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Mar 1, 2012

First Submission Date that Met QC Criteria

Mar 6, 2012

First Posted Date

Mar 7, 2012Estimated

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

Mar 6, 2012

Last Update Posted Date

Mar 7, 2012Estimated

Name	Class
Ministry of Health, France	OTHER_GOV

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

Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.

Detailed Description

Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. Thus, only 50-60% of patients with multiple myeloma or non-Hodgkin lymphoma respond to ESAs. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
response to erythropoietin	Complete response : increase of 2g/dl of erythropoietin rate or stopping of transfusion requirements. Partial response : increase of 1 to 2g/dl rate of erythropoietin or 50% reduction of transfusion requirements.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
endogenous erythropoietin rate		Within 8 days before inclusion
hemoglobin rate	Weeks 0 = first ESAs injection	Weeks 0,4,8 and 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over 18
patients with non-myeloid haemopathy receiving chemotherapy or myelodysplastic syndrome
indication of ESAs therapy with Hb < 11g/dl

Exclusion Criteria:

uncontrolled hypertension
anemia due to deficiency
pregnant and lactating women
patient who received treatment with erythropoiesis-activating factors in the two months preceding inclusion

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

Non-myeloid haemopathy or Myelodysplastic Syndromes patients with anemia, who needs ESAs treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Escoffre-Barbe Martine, MD	Rennes University Hospital	Principal Investigator
Laviolle Bruno, MD	Rennes University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laval Hospital		Laval		53015	France
Rennes University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D009190	Myelodysplastic Syndromes
D000740	Anemia

Ancestor Terms

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided