NCT00903812

Brief Summary

This is multi-center, international observational study of subjects receiving CHOP-14 or CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites will contribute information on subjects treated at their institution.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,837

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

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

February 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 6, 2018

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

May 14, 2009

Last Update Submit

July 4, 2018

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who had an investigator assessed risk of FN ≥20% and received primary prophylaxis G-CSF

    At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment)

Study Arms (1)

A

No intervention - observational study

Other: No intervention

Interventions

No interventionOTHER

No intervention as observational study

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects greater than or equal to 18 years old. Subjects diagnosed with any histological type of NHL (including both chemotherapy naïve and pre-treated subjects). Subjects planned to receive a minimum of 3 cycles of CHOP-14 or CHOP-21 with or without Rituximab (for subjects enrolled retrospectively, eligibility should be assessed on the profile at time of planning treatment, where treatment initiates on or after 01 Jan 2005, with specific focus on planned chemotherapy and not outcome or number of delivered cycles) . Before any study-specific procedure, the appropriate written informed consent must be obtained for countries where this is required

You may qualify if:

  • Subjects greater than or equal to 18 years old
  • Subjects diagnosed with any histological type of NHL (including both chemotherapy naïve and pre-treated subjects)
  • Subjects planned to receive a minimum of 3 cycles of CHOP-14 or CHOP-21 with or without Rituximab (for subjects enrolled retrospectively, eligibility should be assessed on the profile at time of planning treatment, where treatment initiates on or after 01 Jan 2005, with specific focus on planned chemotherapy and not outcome or number of delivered cycles)
  • Before any study-specific procedure, the appropriate written informed consent must be obtained for countries where this is required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Haioun C, Salar A, Pettengell R, Johnsen HE, Duehrsen U, Rossi FG, Verhoef G, Schwenkglenks M, Jaeger U, Hamilton L, Pujol B, Lugtenburg PJ. Anemia and erythropoiesis-stimulating agent administration in patients with non-Hodgkin lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisolone +/- rituximab chemotherapy: results from an observational study. Leuk Lymphoma. 2011 May;52(5):796-803. doi: 10.3109/10428194.2011.557166. Epub 2011 Feb 21.

    PMID: 21338278BACKGROUND

  • Lugtenburg P, Silvestre AS, Rossi FG, Noens L, Krall W, Bendall K, Szabo Z, Jaeger U. Impact of age group on febrile neutropenia risk assessment and management in patients with diffuse large B-cell lymphoma treated with R-CHOP regimens. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):297-305. doi: 10.1016/j.clml.2012.06.004.

    PMID: 23040435BACKGROUND

  • Pettengell R, Johnsen HE, Lugtenburg PJ, Silvestre AS, Duhrsen U, Rossi FG, Schwenkglenks M, Bendall K, Szabo Z, Jaeger U. Impact of febrile neutropenia on R-CHOP chemotherapy delivery and hospitalizations among patients with diffuse large B-cell lymphoma. Support Care Cancer. 2012 Mar;20(3):647-52. doi: 10.1007/s00520-011-1306-6. Epub 2011 Nov 20.

    PMID: 22101611BACKGROUND

  • Weycker D, Danel A, Marciniak A, Bendall K, Lipsitz M, Pettengell R. Economic costs of chemotherapy-induced febrile neutropenia among patients with non-Hodgkin's lymphoma in European and Australian clinical practice. BMC Cancer. 2012 Aug 22;12:362. doi: 10.1186/1471-2407-12-362.

    PMID: 22913768BACKGROUND

Related Links

Biospecimen

Retention: NONE RETAINED

This is an observational study. No bio-specimens are being collected. Time perspective - this study enrolls both retrospective and prospective subjects

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 18, 2009

Study Start

February 1, 2007

Primary Completion

December 1, 2008

Study Completion

March 1, 2014

Last Updated

July 6, 2018

Record last verified: 2015-09