ChemotherapyPhase 4NCT00524407
Effect of Epoetin Alfa on Hemoglobin, Symptom Distress, and Quality of Life in Patients Receiving Chemotherapy
A Phase 4 study testing Epoetin alfa in people with Chemotherapy and Anemia, run by Ortho Biotech, Inc..
Trial summary
The purpose of this study was to compare the effectiveness of epoetin alfa treatment on hemoglobin (Hb) response, quality of life (QoL), health care resource utilization and patient productivity when epoetin alfa was administered during chemotherapy to patients with mild anemia or after waiting until patients became… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy, Anemia, Cancer
- What is being tested?
- Epoetin alfa
- How many people
- 273 participants
- Where
- No sites listed yet
- Study dates
- Jul 1996to Nov 2002
- Phase
- Phase 4
- 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
Who may be able to join
- Patients must present with non-Hodgkins Lymphoma (Low, Intermediate or High Grade) or Hodgkins Disease, CLL or Multiple Myeloma
- Life expectancy > 6 months with Karnofsky Performance Index of > =70
- Evaluable lesion as objective indicator of response
- Scheduled for at least one myelosuppressive cytotoxic regimen (experimental chemotherapy allowed) for at least 4-6 months
- Patients with reproductive potential must have used an adequate contraceptive method
- Transferrin saturation = 20% and serum ferritin = 50 ng/mL Bone marrow evaluations may be performed to determine if iron stores are adequate
- histologic documentation of disease.
Who cannot join
- Patients with no second active malignancy or history of other malignancy diagnosed within preceding 5 years (other than basal cell carcinoma or cervical cancer)
- No uncontrolled hypertension
- active, unresolved infection
- anemia due to factors other than cancer/chemotherapy, i.e., iron, folate, hemolysis, or GI bleeding
- Receiving Epoetin alfa independent of protocol
- Received chemotherapy with the previous 14 days
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- Prior total lymphoid, extensive abdominal or inverted Y radiation therapy
- No use of interferons or interleukins during study
- No use of nonchemotherapy experimental agents within preceding 30 days
- No Hodgkins Disease patients who are chemotherapy naïve
- Received stem cell transplant.
About this study
Official title: The Effects of PROCRIT (Epoetin Alfa) on Hemoglobin, Symptom Distress, and Quality of Life During Chemotherapy in Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma Patients With Mild to Moderate Anemia
The purpose of this study was to compare the effectiveness of epoetin alfa treatment on hemoglobin (Hb) response, quality of life (QoL), health care resource utilization and patient productivity when epoetin alfa was administered during chemotherapy to patients with mild anemia or after waiting until patients became moderately anemic. Patients with lymphoma, chronic lymphocytic leukemia (CLL) or Multiple Myeloma (MM) were studied.
Read the detailed description
This study was an open-label (patients and investigators knew what treatment was being given), randomized (patients were assigned to a treatment group by chance) study of lymphoma, chronic lymphocytic leukemia (CLL), or multiple myeloma patients. This study addressed the clinical and patient-management consequences of treating mild to moderate anemia (hemoglobin (Hb) between 10 and 12 g/dL). The design of the study compared the effect of treating higher Hb levels to current standard of care criteria on Hb levels, transfusion requirements, and patient reported outcomes (quality of life, health care resource utilization, and productivity). Patients were randomized according to their Hb levels. Two entry criteria were specified during the course of the trial. Initially, patients were enrolled with Hb levels >= 11 g/dL and then randomized to receive 1) Immediate epoetin alfa treatment or 2) Observed after Hb levels fell below 11 g/dL. Epoetin alfa treatment was provided to the Observed group if and when Hb levels fell below 9.0 g/dL. Slow recruitment of patients in to the study resulted in a protocol amendment. Subsequently, if a patient presented with a Hb between 10 and 12 g/dL, the patient was randomized to the Immediate or to the Observed groups. Patients presenting with Hgb > 12 g/dL but otherwise eligible, were not randomized until Hb dropped to <=12 g/dL. Patients remained in the study for up to 36 weeks. Safety assessments were performed throughout the study and included obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. The starting dose of PROCRIT (Epoetin alfa) was administered subcutaneously (sc) as 40,000 Units (U) once weekly (qw). If after 3-4 weeks of therapy, the Hb did not increase by > 1.0 g/dL, the dose was increased to 60,000 U sc qw. If at any time, the Hb rose above 15 g/dL on 2 consecutive evaluations, PROCRIT (Epoetin alfa) was stopped until the Hb dropped to below 13 g/dL and then resumed.
- Conditions
- Chemotherapy, Anemia, Cancer
- Being tested
- Epoetin alfa
- Keywords
- Anemia, hemoglobin, chemotherapy, hematologic response, subcutaneous injection, Epoetin alfa, FACT-An, LASA, PROCRIT
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the change in quality of life score as demonstrated by the FACT-An (Functional Assessment in Cancer Therapy - Anemia) and LASA (Linear Analogue Assessment Scale) tools over the 36 week study period.
Secondary outcomes (1)
Health care resource utilization. To measure transfusion requirements and change in Hb levels. All patients were followed for survival until closure of study which was the time the last patient in the entire study completed study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startJul 1996
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChemotherapyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ortho Biotech, Inc. Clinical Trial, Study director, Ortho Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524407
- Sponsor's protocol ID
- CR005125
- Status last verified
- Apr 2010
- First submitted
- 30 Aug 2007
- Last updated
- 2 Apr 2010
- Results posted
- No
Publications
Straus DJ, Testa MA, Sarokhan BJ, Czuczman MS, Tulpule A, Turner RR, Riggs SA. Quality-of-life and health benefits of early treatment of mild anemia: a randomized trial of epoetin alfa in patients receiving chemotherapy for hematologic malignancies. Cancer. 2006 Oct 15;107(8):1909-17. doi: 10.1002/cncr.22221.
PubMed 16977654
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of PROCRIT (Epoetin Alfa) on Hemoglobin, Symptom Distress, and Quality of Life During Chemotherapy in Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma Patients With Mild to Moderate Anemia
- ClinicalTrials.gov ID
- NCT00524407
- Acronym / sponsor ID
- CR005125
- Conditions
- Chemotherapy, Anemia, Cancer
- Keywords
- Anemia, hemoglobin, chemotherapy, hematologic response, subcutaneous injection, Epoetin alfa, FACT-An, LASA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Ortho Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 1996
- Study completion
- Nov 2002 (actual)
- First posted
- 3 Sep 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.
The purpose of this study was to compare the effectiveness of epoetin alfa treatment on hemoglobin (Hb) response, quality of life (QoL), health care resource utilization and patient productivity when epoetin alfa was administered during chemotherapy to patients with mild anemia or after waiting until patients became moderately anemic. Patients with lymphoma, chronic lymphocytic leukemia (CLL) or Multiple Myeloma (MM) were studied.
Detailed description
This study was an open-label (patients and investigators knew what treatment was being given), randomized (patients were assigned to a treatment group by chance) study of lymphoma, chronic lymphocytic leukemia (CLL), or multiple myeloma patients. This study addressed the clinical and patient-management consequences of treating mild to moderate anemia (hemoglobin (Hb) between 10 and 12 g/dL). The design of the study compared the effect of treating higher Hb levels to current standard of care criteria on Hb levels, transfusion requirements, and patient reported outcomes (quality of life, health care resource utilization, and productivity). Patients were randomized according to their Hb levels. Two entry criteria were specified during the course of the trial. Initially, patients were enrolled with Hb levels >= 11 g/dL and then randomized to receive 1) Immediate epoetin alfa treatment or 2) Observed after Hb levels fell below 11 g/dL. Epoetin alfa treatment was provided to the Observed group if and when Hb levels fell below 9.0 g/dL. Slow recruitment of patients in to the study resulted in a protocol amendment. Subsequently, if a patient presented with a Hb between 10 and 12 g/dL, the patient was randomized to the Immediate or to the Observed groups. Patients presenting with Hgb > 12 g/dL but otherwise eligible, were not randomized until Hb dropped to <=12 g/dL. Patients remained in the study for up to 36 weeks. Safety assessments were performed throughout the study and included obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. The starting dose of PROCRIT (Epoetin alfa) was administered subcutaneously (sc) as 40,000 Units (U) once weekly (qw). If after 3-4 weeks of therapy, the Hb did not increase by > 1.0 g/dL, the dose was increased to 60,000 U sc qw. If at any time, the Hb rose above 15 g/dL on 2 consecutive evaluations, PROCRIT (Epoetin alfa) was stopped until the Hb dropped to below 13 g/dL and then resumed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must present with non-Hodgkins Lymphoma (Low, Intermediate or High Grade) or Hodgkins Disease, CLL or Multiple Myeloma
- Life expectancy > 6 months with Karnofsky Performance Index of > =70
- Evaluable lesion as objective indicator of response
- Scheduled for at least one myelosuppressive cytotoxic regimen (experimental chemotherapy allowed) for at least 4-6 months
- Patients with reproductive potential must have used an adequate contraceptive method
Key exclusion criteria (11 listed)
- Patients with no second active malignancy or history of other malignancy diagnosed within preceding 5 years (other than basal cell carcinoma or cervical cancer)
- No uncontrolled hypertension
- active, unresolved infection
- anemia due to factors other than cancer/chemotherapy, i.e., iron, folate, hemolysis, or GI bleeding
- Receiving Epoetin alfa independent of protocol
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 | Drug | – |
Primary outcome
To measure the change in quality of life score as demonstrated by the FACT-An (Functional Assessment in Cancer Therapy - Anemia) and LASA (Linear Analogue Assessment Scale) tools over the 36 week study period.
1 secondary outcome
Health care resource utilization. To measure transfusion requirements and change in Hb levels. All patients were followed for survival until closure of study which was the time the last patient in the entire study completed study participation.
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 2 Apr 2010.
- Results publication: PubMed 16977654Straus DJ, Testa MA, Sarokhan BJ, Czuczman MS, Tulpule A, Turner RR, Riggs SA. Quality-of-life and health benefits of early treatment of mild anemia: a randomized trial of epoetin alfa in patients receiving chemotherapy for hematologic malignancies. Cancer. 2006 Oct 15;107(8):1909-17. doi: 10.1002/cncr.22221.
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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.
Ortho Biotech, Inc. Clinical Trial study director
Ortho Biotech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin alfa in people with Chemotherapy and Anemia, run by Ortho Biotech, Inc..
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 7 inclusion and 11 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 2 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To measure the change in quality of life score as demonstrated by the FACT-An (Functional Assessment in Cancer Therapy - Anemia) and LASA (Linear Analogue Assessment Scale) tools over the 36 week study period.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524407, which also lists 1 linked publication.
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 2 Apr 2010.