NCT00524407

Brief 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 moderately anemic. Patients with lymphoma, chronic lymphocytic leukemia (CLL) or Multiple Myeloma (MM) were studied.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 1996

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
Last Updated

April 2, 2010

Status Verified

April 1, 2010

First QC Date

August 30, 2007

Last Update Submit

April 1, 2010

Conditions

ChemotherapyAnemiaCancer

Keywords

Anemiahemoglobinchemotherapyhematologic responsesubcutaneous injectionEpoetin alfaFACT-AnLASAPROCRIT

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Epoetin alfaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16977654RESULT

MeSH Terms

Conditions

AnemiaNeoplasms

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Ortho Biotech, Inc. Clinical Trial

    Ortho Biotech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2007

First Posted

September 3, 2007

Study Start

July 1, 1996

Study Completion

November 1, 2002

Last Updated

April 2, 2010

Record last verified: 2010-04