Epoetin Alfa or Epoetin Beta With or Without Iron Infusio... | NCT00482716 | Trialant
NCT00482716
Sponsor
St. Bartholomew's Hospital
Status
Unknown status
Last Update Posted
Jan 10, 2014Estimated
Enrollment
80Estimated
Phase
Phase 3
Conditions
Anemia
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
epoetin alfa
epoetin beta
iron dextran complex
iron sucrose injection
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00482716
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000549549
Secondary IDs
ID
Type
Description
Link
BARTS-06/Q0605/93
ISRCTN11830961
EU-20731
Brief Title
Epoetin Alfa or Epoetin Beta With or Without Iron Infusion in Treating Anemia in Patients With Cancer
Official Title
Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Aug 2009
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Active, not recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2007
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Jun 4, 2007
First Submission Date that Met QC Criteria
Jun 4, 2007
First Posted Date
Jun 5, 2007Estimated
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
Jan 9, 2014
Last Update Posted Date
Jan 10, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
St. Bartholomew's HospitalOTHER
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Epoetin alfa and epoetin beta may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether epoetin alfa or epoetin beta are more effective when given with or without iron infusion in treating anemia in patients with cancer.
PURPOSE: This randomized phase III trial is studying epoetin alfa or epoetin beta to compare how well they work with or without iron infusion in treating anemia in patients with cancer.
Detailed Description
OBJECTIVES:
Compare the efficacy of recombinant epoetin alfa or epoetin beta with vs without parenteral iron in anemic, iron-replete patients with nonmyeloid malignancies.
OUTLINE: This is a randomized, controlled, open-label, prospective study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive recombinant erythropoietic stimulatory activity (ESA) therapy comprising epoetin alfa or epoetin beta subcutaneously (SC) on day 1.
Arm II: Patients receive ESA therapy as in arm I and parenteral iron (i.e., low molecular weight iron dextran complex IV over 5-10 minutes or iron sucrose injection IV over 10-30 minutes) on day 1.
In both arms, treatment repeats weekly for up to 10 weeks or until hemoglobin reaches 13 g/dL, whichever comes first.
Conditions Module
Conditions
Anemia
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II marginal zone lymphoma
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
80Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
epoetin alfa
Biological
epoetin beta
Biological
iron dextran complex
Dietary Supplement
iron sucrose injection
Dietary Supplement
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum hemoglobin achieved
Secondary Outcomes
Measure
Description
Time Frame
Time to zenith hemoglobin or achievement of hemoglobin level ≥ 13 g/dL
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of nonmyeloid malignancy
No primary bone marrow malignancies except multiple myeloma, chronic lymphocytic leukemia, or indolent non-Hodgkin lymphoma
Candidate for erythropoietin stimulatory activity therapy for anemia due to cancer and/or chemotherapy
Baseline hemoglobin ≤ 10.5 g/dL
Planning to receive ≥ 6 additional weeks of chemotherapy for the malignancy
Demonstrates iron-replete status as defined by all of the following parameters:
Percent saturation of transferrin ≥ 20%
Serum ferritin 225-2,250 pmol/L
Reticulocyte hemoglobin content > 31 pg
Zinc protoporphyrin < 80 µg/dL
No anemia of origin other than cancer or cancer chemotherapy
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
No allergy or intolerance to recombinant epoetin alfa or epoetin beta
No known sensitivity to iron sucrose injection or iron dextran complex
No uncontrolled hypertension
No active infection
No active bleeding
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior iron sucrose injection or iron dextran complex therapy
More than 6 months since prior and no concurrent transfusion
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
16 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Samir G Agrawal, MD, PhD
St. Bartholomew's Hospital
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Saint Bartholomew's Hospital
London
England
EC1A 7BE
United Kingdom
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
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
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
contiguous stage II small lymphocytic lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage I marginal zone lymphoma
stage III marginal zone lymphoma
stage IV marginal zone lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
recurrent adult diffuse small cleaved cell lymphoma