IMPACT Non Hodgkins Lymphoma (NHL) Study

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Non-Hodgkin's Lymphoma	Other: No intervention

Detailed Description:

This is a 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.

To avoid geographical bias, sites will be selected to represent the spread of subjects in each country. Each site will be initially limited to 5 retrospective subjects and 10 prospective subjects (15 subjects per site) but sites may be asked to contribute further subjects to approximately 10 retrospective subjects and 20 prospective subjects.

Retrospective subjects may include any subject that has completed all cycles of chemotherapy treatment prior to date of site initiation. Prospective subjects which may be considered for the study are any subject planned for CHOP-14 or CHOP-21 (with or without Rituximab) treatment after the site initiation visit.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	1837 participants
Official Title:	A Retrospective and Prospective Observational Study Reviewing Supportive Care Management of NHL Patients Treated With CHOP-14 or 21 Chemotherapy(With or Without Rituximab) (CHOP = Cyclophosphamide, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine), Prednisone Chemotherapy )
Study Start Date :	February 2007
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	March 2014

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
A; No intervention - observational study	Other: No intervention; No intervention as observational study

Outcome Measures

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Primary Outcome Measures :

1. Proportion of subjects who had an investigator assessed risk of FN ≥20% and received primary prophylaxis G-CSF [ Time Frame: At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment) ]

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability 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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subjects receiving CHOEP ((CHOP = Cytoxan, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine),Etoposide, Prednisone Chemotherapy )or CNOP (Cytoxan, Novantrone, Oncovin (Vincristine),Etoposide, Prednisone) chemotherapy are not eligible for inclusion in this study

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Amgen

Investigators

Study Director:	MD	Amgen

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

AmgenTrials clinical trials website 

Publications:

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.

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.

Schwenkglenks M, Bendall KL, Pfeil AM, Szabo Z, Pettengell R. External validation of a risk model of febrile neutropenia occurrence in patients with non-Hodgkin lymphoma. Leuk Lymphoma. 2013 Nov;54(11):2426-32. doi: 10.3109/10428194.2013.780287. Epub 2013 Apr 17.

Salar A, Haioun C, Rossi FG, Duehrsen U, Pettengell R, Johnsen HE, Jaeger U, Verhoef G, Schwenkglenks M, Bacon P, Bendall K, Lugtenburg PJ. The need for improved neutropenia risk assessment in DLBCL patients receiving R-CHOP-21: findings from clinical practice. Leuk Res. 2012 May;36(5):548-53. doi: 10.1016/j.leukres.2012.02.002. Epub 2012 Mar 3.

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.

Pettengell R, Johnsen HE, Lugtenburg PJ, Silvestre AS, Dührsen 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. Erratum in: Support Care Cancer. 2013 Feb;21(2):653. Johnson, Hans E [corrected to Johnsen, Hans E].

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT00903812 History of Changes
Other Study ID Numbers:	20060297
First Posted:	May 18, 2009
Last Update Posted:	July 16, 2014
Last Verified:	July 2014

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms	Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases