NCT00217425|CompletedPhase 2Results

Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms

Bevacizumab and CHOP (A-CHOP) in Combination for Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms

Eastern Cooperative Oncology Group ClinicalTrials.gov

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3 other identifiers

CDR0000441194U10CA021115E2404

Study Type

interventional

Target

Locations

1 country

Sites

110

Timeline

RegisteredSep 2005

StartedSep 2006

CompletionMar 2014

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with several chemotherapy drugs (combination chemotherapy) works in treating patients with peripheral T-cell lymphoma or natural killer cell neoplasms.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline

Completed

Started Sep 2006

Typical duration for phase_2 lymphoma

Geographic Reach

1 country

110 active sites

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

7.5 years study duration

First Submitted

Initial submission to the registry

September 20, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed

12 months until next milestone

Study Start

First participant enrolled

September 14, 2006

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed

2 months until next milestone

Results Posted

Study results publicly available

May 7, 2014

Completed

Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

5.6 years

First QC Date

September 20, 2005

Results QC Date

February 20, 2014

Last Update Submit

June 14, 2023

Conditions

Lymphoma

Keywords

anaplastic large cell lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomaperipheral T-cell lymphoma

Outcome Measures

Primary Outcomes (1)

12-Month Progression-Free Survival (PFS)
12-month progression-free survival is defined as the probability of patients remaining alive and progression-free at 12 months from study entry.
Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.

Secondary Outcomes (2)

Overall Response Rate
Assessed after cycle 3, cycle 6, and cycle 8 (if given).
3-Year Overall Survival
Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.

Study Arms (1)

Treatment (A-CHOP followed by MA)

EXPERIMENTAL

Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 \[max. 2 mg\]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.

Biological: bevacizumabDrug: cyclophosphamideDrug: doxorubicinDrug: prednisoneDrug: vincristine

Interventions

bevacizumabBIOLOGICAL

A - CHOP: 15 mg/kg IV infusion once every 21 days for 6-8 cycles. Bevacizumab is to be administered prior to CHOP therapy. Continuous bevacizumab: 15 mg/kg IV infusion once every 21 days. Initial dose should be infused over 90 minutes. If no adverse reactions occur, the second dose should be administered over 60 minutes. Again, if no adverse reactions occur, the third and subsequent doses should be administered over 30 minutes. If infusion-related adverse reactions occur, subsequent infusions should be administered over the shortest period that is well-tolerated. Infusions should be run in via a volumetric infusion device. Do NOT administer as an IV push or bolus.

Also known as: NSC 704865,, RhuMAb VEGF,, Recombinant Humanized Monoclonal Anti-VEGF Antibody.