AnemiaPhase 3NCT00482716
Epoetin Alfa or Epoetin Beta With or Without Iron Infusion in Treating Anemia in Patients With Cancer
A Phase 3 study testing epoetin alfa, epoetin beta and iron dextran complex in people with Anemia and Leukemia, run by St. Bartholomew's Hospital at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- epoetin alfa, epoetin beta and iron dextran complex
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2007to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Saint Bartholomew's Hospital
London, England, EC1A 7BE
About this study
Official title: Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia
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.
Read the 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
- Anemia, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- epoetin alfa, epoetin beta, iron dextran complex, iron sucrose injection
- 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, 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
- Medical subject headings
- Anemia, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaBiological
epoetin betaBiological
iron dextran complexDietary supplement
iron sucrose injectionDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum hemoglobin achieved
Secondary outcomes (1)
Time to zenith hemoglobin or achievement of hemoglobin level ≥ 13 g/dL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Bartholomew's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Samir G Agrawal, MD, PhD, Study chair, St. Bartholomew's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482716
- Sponsor's protocol ID
- CDR0000549549
- Other IDs
- BARTS-06/Q0605/93, ISRCTN11830961, EU-20731
- Status last verified
- Aug 2009
- First submitted
- 4 Jun 2007
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia
- ClinicalTrials.gov ID
- NCT00482716
- Acronym / sponsor ID
- CDR0000549549
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St. Bartholomew's HospitalUniversity, hospital or other
- Study start
- Jan 2007
- First posted
- 5 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epoetin alfa | Biological | – |
| epoetin beta | Biological | – |
| iron dextran complex | Dietary supplement | – |
| iron sucrose injection | Dietary supplement | – |
Primary outcome
Maximum hemoglobin achieved
1 secondary outcome
Time to zenith hemoglobin or achievement of hemoglobin level ≥ 13 g/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir G Agrawal, MD, PhD study chair
St. Bartholomew's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa, epoetin beta and iron dextran complex in people with Anemia and Leukemia, run by St. Bartholomew's Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum hemoglobin achieved. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.