NCT01099202

Brief Summary

The goal of this clinical research study is to learn if Procrit (epoetin alfa) will decrease the need for blood transfusions in patients with Acute Lymphocytic Leukemia (ALL), Lymphoblastic Lymphoma (LL), or Burkitt's who are receiving chemotherapy. Another goal is to study the remission rates in patients with cancer who have received treatment with epoetin alfa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P75+ for not_applicable leukemia

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable leukemia

Geographic Reach
1 country

1 active site

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

March 1, 2003

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 27, 2012

Completed
Last Updated

August 27, 2012

Status Verified

July 1, 2012

Enrollment Period

8.2 years

First QC Date

April 5, 2010

Results QC Date

June 12, 2012

Last Update Submit

July 24, 2012

Conditions

Leukemia

Keywords

ProcritAcute Lymphocytic LeukemiaLymphoblastic LymphomaBurkitt'sChemotherapyHyper-CVADaugmented BFMEpoetin alfaEpogenErythropoietin

Outcome Measures

Primary Outcomes (2)

  • Mean Number of RBC Units Transfused During Initial 5 Months of Treatment

    Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.

    5 weeks to 5 Months

  • Number of PRBC Transfusions During Initial 5 Months of Treatment

    Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months.

    5 weeks to 5 Months

Study Arms (2)

Procrit

EXPERIMENTAL

Starting dose 40,000 units subcutaneously once a week with chemotherapy.

Drug: Procrit (epoetin alfa)

No Procrit

NO INTERVENTION

No intervention.

Interventions

Procrit (epoetin alfa)DRUG

Starting dose 40,000 Units subcutaneously once a week during your regularly scheduled chemotherapy for up to 6 courses of chemotherapy (around 5 months).

Also known as: epoetin alfa, Epogen, Erythropoietin
Procrit

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of ALL, LL, or Burkitt's receiving induction chemotherapy with Hyper-CVAD, any variant of Hyper-CVAD or augmented BFM at MD Anderson Cancer Center.
  • Patients must be enrolled on the study + / - (plus or minus) 14 days from the start of induction chemotherapy.
  • Patients with relapsed ALL, LL, or Burkitt's are eligible, but must have had a remission duration of 1 year or longer.

You may not qualify if:

  • Hemoglobin greater than or equal to 10 g/dL.
  • Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 3 months.
  • Patients with known hypersensitivity to mammalian-cell derived products or to human albumin.
  • Uncontrolled hypertension
  • History of thrombotic vascular event.
  • Pregnant or lactating women.
  • Anemia due to factors other than cancer, deficiencies of B12, folate, or iron (only with concurrent treatment of these deficiencies).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Epoetin AlfaErythropoietin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Jorge Cortes M.D./Professor
Organization
The University of Texas M. D. Anderson Cancer Center
eharriso@mdanderson.org
713/794-5783

Study Officials

  • Jorge Cortes, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2010

First Posted

April 6, 2010

Study Start

March 1, 2003

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 27, 2012

Results First Posted

August 27, 2012

Record last verified: 2012-07

Locations

US(1)