Chemotherapy-induced Symptomatic AnaemiaNCT01626547
Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology
An observational study of Chemotherapy-induced Symptomatic Anaemia and Solid Tumours, run by Hospira, now a wholly owned subsidiary of Pfizer at 39 sites in Germany.
Trial summary
The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Symptomatic Anaemia, Solid Tumours, Malignant Lymphomas
- How many people
- 291 participants
- Where
- 39 sitesGermany
- Study dates
- Dec 2010to Jul 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chemotherapy-induced symptomatic anaemia. Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
Who may be able to join
- Patients age ≥18 years .
- Patients present with chemotherapy-induced symptomatic anaemia.
- Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
- The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
- Patients eligible for epoetin alfa biosimilar treatment.
Who cannot join
- Patients are not receiving chemotherapy.
- Patients already included in an epoetin zeta study.
- Patients presenting with the contraindications to epoetin zeta.
- Patients presenting with the hypersensitivity to the active substance or any of the excipients.
- The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA).
- Patients with uncontrolled hypertension.
- Patients who cannot receive adequate prophylaxis by antithrombotic agents.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Germany39 sites
Study site
Alzey, 55232
Study site
Bad Säckigen, 79713
Study site
Berlin, 10367
Study site
Berlin, 12627
Study site
Berlin, 13593
Study site
Bonn, 53123
Study site
Bonn, 53177
Study site
Borken, 46325
Study site
Brandenburg, 14770
Study site
Chemnitz, 09113
Study site
Cottbus, 03046
Study site
Essen, 45239
Study site
Frankenthal, 67227
Study site
Garbsen, 30827
Study site
Halberstadt, 38820
Study site
Hanover, 30171
Study site
Herne, 44623
Study site
Holzkirchen, 83607
Study site
Krefeld, 47798
Study site
München, 80638
Study site
München, 81479
Study site
Münster, 48149
Study site
Neuss, 41462
Study site
Nuremberg, 90409
Study site
Oberhausen, 46045
Study site
Oberhausen, 46145
Study site
Olpe, 57462
Study site
Oranienburg, 16515
Study site
Paderborn, 33098
Study site
Parchim, 19370
Study site
Plauen, 08523
Study site
Remscheid, 42859
Study site
Rodgau, 63110
Study site
Rötha, 04571
Study site
Schönebeck, 39218
Study site
Soest, 59494
Study site
Stralsund, 18435
Study site
Stuttgart, 70190
Study site
Velbert, 42551
About this study
Official title: Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology; Non-interventional, Observational, Prospective Study
The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.
Read the detailed description
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study in adult patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anaemia and being treated with Retacrit® to correct haemoglobin levels.
- Conditions
- Chemotherapy-induced Symptomatic Anaemia, Solid Tumours, Malignant Lymphomas, Multiple Myeloma
- Keywords
- symptomatic anameia
- Medical subject headings
- Lymphoma, Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Change and corrected Hemoglobin levels
Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
Measured: 6 months
Secondary outcomes (5)
Observation of blood value development
Observation of blood value development: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation
Measured: 6 months
Evaluation of the profiles of treated patients
Measured: 6 months
Evaluation of prescriber's therapy plan
Measured: 6 months
Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics
Measured: 6 months
Observation of the tolerability profile of Epoetin Zeta
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Symptomatic AnaemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626547
- Sponsor's protocol ID
- ORHEO
- Status last verified
- Jul 2015
- First submitted
- 7 Jun 2012
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology; Non-interventional, Observational, Prospective Study
- ClinicalTrials.gov ID
- NCT01626547
- Acronym / sponsor ID
- ORHEO
- Conditions
- Chemotherapy-induced Symptomatic Anaemia, Solid Tumours, Malignant Lymphomas, Multiple Myeloma
- Keywords
- symptomatic anameia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Jun 2012 (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.
The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.
Detailed description
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study in adult patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anaemia and being treated with Retacrit® to correct haemoglobin levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chemotherapy-induced symptomatic anaemia. Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
Key inclusion criteria (5 listed)
- Patients age ≥18 years .
- Patients present with chemotherapy-induced symptomatic anaemia.
- Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
- Patients eligible for epoetin alfa biosimilar treatment.
Key exclusion criteria (7 listed)
- Patients are not receiving chemotherapy.
- Patients already included in an epoetin zeta study.
- Patients presenting with the contraindications to epoetin zeta.
- Patients presenting with the hypersensitivity to the active substance or any of the excipients.
- The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change and corrected Hemoglobin levels
Time frame: 6 months
Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
5 secondary outcomes
Observation of blood value development
Time frame: 6 months
Evaluation of the profiles of treated patients
Time frame: 6 months
Evaluation of prescriber's therapy plan
Time frame: 6 months
Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics
Time frame: 6 months
Observation of the tolerability profile of Epoetin Zeta
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Symptomatic Anaemia and Solid Tumours, run by Hospira, now a wholly owned subsidiary of Pfizer at 39 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change and corrected Hemoglobin levels (time frame: 6 months). 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 20 Mar 2017.