NCT00261677

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing of PROCRIT® (a glycoprotein that stimulates red blood cell production) versus placebo in the treatment of anemia in children with cancer undergoing chemotherapy, and to assess its effect on the quality of life.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2000

Typical duration for phase_3

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

August 1, 2000

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
Last Updated

May 23, 2011

Status Verified

April 1, 2010

First QC Date

December 2, 2005

Last Update Submit

May 19, 2011

Conditions

AnemiaHodgkin DiseaseLeukemiaLymphoma, Non-hodgkin

Keywords

Anemiacancersolid tumorHodgkin's DiseaseAcute Lymphocytic Leukemia (ALL)Non-Hodgkin's Lymphoma (NHL)Quality of LifehemoglobinEpoetin alfa

Outcome Measures

Primary Outcomes (1)

  • Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.

Secondary Outcomes (1)

  • Parents' Quality of Life assessments on the Pediatric Quality of Life Inventory (PedsQL Inventory); Patient- and parent-reported assessments on the PedsQL Cancer Module; hemoglobin levels; transfusion requirements

Interventions

epoetin alfaDRUG

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with a confirmed new diagnosis of malignant solid tumor, Hodgkin's disease, Acute Lymphocytic Leukemia (ALL) or Non-Hodgkin's Lymphoma (NHL)
  • scheduled to receive first myelosuppressive chemotherapy within 7 days of baseline or have received up to the second myelosuppressive chemotherapy within 60 days prior to study enrollment, and scheduled to receive chemotherapy over a minimum period of 12 weeks after study enrollment
  • anemic according to age-based and gender-based criteria (hemoglobin level of \< 10.5 g/dL for boys and girls ages 5 to 12 years, \< 11.0 g/dL for girls older than 12 years, \< 12.0 g/dL for boys older than 12 years)
  • have an indwelling central venous access device (e.g., subcutaneous port, external Hickman-Broviac-type catheter, or peripherally inserted central catheter) or existing peripheral intravenous catheter in place for chemotherapy administration
  • both male or female patients who are reproductive potential and sexually active must be practicing an acceptable method of birth control throughout the entire study
  • Parent/legal guardian must have read and signed the informed consent and patients must have provided assent, as appropriate according to state and IRB requirements

You may not qualify if:

  • Diagnosis of myeloid leukemia or other myeloid malignancy (e.g., granulocytic sarcoma)
  • diagnosis of Down's Syndrome, tumor of the central nervous system (CNS) or symptomatic metastatic CNS disease (for the solid tumor/Hodgkin's Disease stratum), or presence of symptomatic CNS disease at diagnosis (for the Acute Lymphocytic Leukemia/Non-Hodgkin's Lymphoma stratum)
  • scheduled to receive cranial irradiation during the study period, or has received cranial irradiation within 30 days prior to study enrollment
  • have an inherited form of anemia (hemoglobinopathy, thalassemia, red cell membrane defect, red cell enzyme deficiency) or a Coombs-positive hemolytic anemia
  • elevated serum creatinine based upon age of study entry ( \> 0.8 mg/dL for children younger than 10 years, \> 1.1 mg/dL for children 10 - 15 years, \> 1.4 mg/dL for children older than 15 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Razzouk BI, Hord JD, Hockenberry M, Hinds PS, Feusner J, Williams D, Rackoff WR. Double-blind, placebo-controlled study of quality of life, hematologic end points, and safety of weekly epoetin alfa in children with cancer receiving myelosuppressive chemotherapy. J Clin Oncol. 2006 Aug 1;24(22):3583-9. doi: 10.1200/JCO.2005.03.4371.

    PMID: 16877725RESULT

Related Links

MeSH Terms

Conditions

AnemiaHodgkin DiseaseLeukemiaLymphoma, Non-HodgkinNeoplasmsPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Lymphoid

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ortho Biotech Products, L.P. Clinical Trial

    Ortho Biotech Products, L.P.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 5, 2005

Study Start

August 1, 2000

Study Completion

October 1, 2003

Last Updated

May 23, 2011

Record last verified: 2010-04