- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00524407
Effect of Epoetin Alfa on Hemoglobin, Symptom Distress, and Quality of Life in Patients Receiving Chemotherapy
April 1, 2010 updated by: Ortho Biotech, Inc.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
273
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
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.
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ortho Biotech, Inc. Clinical Trial, Ortho Biotech, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1996
Study Completion (Actual)
November 1, 2002
Study Registration Dates
First Submitted
August 30, 2007
First Submitted That Met QC Criteria
August 30, 2007
First Posted (Estimate)
September 3, 2007
Study Record Updates
Last Update Posted (Estimate)
April 2, 2010
Last Update Submitted That Met QC Criteria
April 1, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005125
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
Clinical Trials on Epoetin alfa
-
Hospital de Clinicas de Porto AlegreOswaldo Cruz Foundation; Rio Grande do Sul State Health Department - SES/RSCompletedComparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis
-
MegalabsAzidus LaboratoriesNot yet recruitingAnemia of Chronic Kidney DiseaseUruguay
-
M.D. Anderson Cancer CenterCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech, Inc.Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.CompletedKidney Diseases | Anemia
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedBlood Transfusion | Orthopedic Surgery | Orthopedic Procedures | Mammaplasty | Cardiovascular Surgical Procedures | Blood Transfusion, Autologous
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.Terminated
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Products, L.P.CompletedCritical Illness | Anemia