Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-cell Lymphoma

NCT00644124 | Completed Phase 1

• 2 other identifiers: TCD10173EudraCT 2007-003737-16
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the selected dose of aflibercept when it is combined with R-CHOP treatment (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate) administered every 2 weeks or every 3 weeks, in non Hodgkin B-cell lymphoma, and to determine how the body handles aflibercept when it is administered with R-CHOP.

Conditions

Lymphoma, Non-Hodgkin

Keywords

Non-Hodgkin's lymphoma; angiogenesis inhibitors; CHOP protocol

Outcome Measures

Primary Outcomes (1)

• selected dose of aflibercept based on Dose Limiting Toxicities observed

  cycle 1 +/- 2

Secondary Outcomes (4)

• Adverse events

  treatment period

• Response rate

  cycle 2, 4 and 8

• Progression free survival

  study period

• Biomarkers

  Study period

Study Arms (2)

Aflibercept RCHOP 14

EXPERIMENTAL

Aflibercept (25 mg/ml by IV over an hour) in combination with fixed dose of rituximab (R), cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) administered every 2 weeks. A dose of 2.0 mg/kg administered as Dose Level 1, 4.0 mg/kg as Dose Level 2, and 6.0 mg/kg dose as Dose level 3.

Drug: aflibercept

Aflibercept RCHOP 21

EXPERIMENTAL

Aflibercept (25 mg/ml by IV over an hour) in combination with fixed dose of rituximab (R), cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) administered every 3 weeks. A dose of 3.0 mg/kg administered as Dose Level 1, 6.0 mg/kg as Dose Level 2, and 8.0 mg/kg dose as Dose level 3.

Drug: aflibercept

Interventions

aflibercept DRUG

in combination with standard treatment R-CHOP

Aflibercept RCHOP 14; Aflibercept RCHOP 21

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-Hodgkin B-cell lymphoma, good condition, not previously treated

You may not qualify if:

• Contraindication to any drug contained in the R-CHOP (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate)
• Cerebral or leptomeningeal involvement.
• History of another neoplasm (Adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for \> 5 years are allowed)
• Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to the first drug intake
• Any acute or chronic medical condition, which could impair the ability of the patient to participate to the study or could interfere with interpretation of study results
• Uncontrolled diabetes mellitus
• Uncontrolled hypertension
• Abnormal kidney function
• Evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy
• Pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an effective method of contraception
• History of hypersensitivity to any Trap agents or recombinant proteins

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Sanofi-Aventis Administrative Office

Paris, France

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Corinne Haioun, MD

  Groupe d'Etudes du Lymphome de l'Adulte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2008
• First Posted: March 26, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 6, 2016

Record last verified: 2016-05

Locations

FR (1)