Trial record 1 of 1 for:
tcd10173
Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-cell Lymphoma
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| ClinicalTrials.gov Identifier: NCT00644124 |
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Recruitment Status :
Completed
First Posted : March 26, 2008
Last Update Posted : May 6, 2016
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Non-Hodgkin | Drug: aflibercept | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 25 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Open-label Dose-escalation Study of Intravenous Aflibercept (AVE0005, VEGF Trap) in Combination With R-CHOP Administered Every 2 Weeks or Every 3 Weeks in Patients With Non Hodgkin's B-cell Lymphoma |
| Study Start Date : | March 2008 |
| Actual Primary Completion Date : | October 2011 |
| Actual Study Completion Date : | October 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Aflibercept RCHOP 14
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.
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Drug: aflibercept
in combination with standard treatment R-CHOP |
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Experimental: Aflibercept RCHOP 21
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.
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Drug: aflibercept
in combination with standard treatment R-CHOP |
Primary Outcome Measures :
- selected dose of aflibercept based on Dose Limiting Toxicities observed [ Time Frame: cycle 1 +/- 2 ]
Secondary Outcome Measures :
- Adverse events [ Time Frame: treatment period ]
- Response rate [ Time Frame: cycle 2, 4 and 8 ]
- Progression free survival [ Time Frame: study period ]
- Biomarkers [ Time Frame: Study period ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with non-Hodgkin B-cell lymphoma, good condition, not previously treated
Exclusion Criteria:
- Contraindication to any drug contained in the R-CHOP (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate)
- Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of inclusion
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644124
Locations
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Principal Investigator: | Corinne Haioun, MD | Groupe d'Etudes du Lymphome de l'Adulte |
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00644124 History of Changes |
| Other Study ID Numbers: |
TCD10173 EudraCT 2007-003737-16 |
| First Posted: | March 26, 2008 Key Record Dates |
| Last Update Posted: | May 6, 2016 |
| Last Verified: | May 2016 |
Keywords provided by Sanofi:
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Non-Hodgkin's lymphoma angiogenesis inhibitors CHOP protocol |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |