CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
bevacizumab +4 morebiological
Likely dose
Bevacizumab 15 mg/kg IV infusion once every 21 days for 6–8 cycles, administered prior to CHOP therapyAI-extracted
Key inclusion· 8
  • Diagnosis of peripheral T-cell or natural killer cell neoplasm (any stage; HTLV-positive tumors allowed)
  • At least one objective measurable disease parameter (abnormal PET only if confirmed by CT or other imaging)
  • Age 18 years or older
  • ECOG performance status 0–2
Key exclusion· 11
  • ALK-positive T-cell large cell lymphoma (ALK-negative allowed)
  • Cutaneous T-cell lymphoma
  • History of or radiographic evidence of CNS metastasis, including previously treated, resected, asymptomatic brain lesions, or leptomeningeal involvement
  • Cerebrovascular accident, myocardial infarction, or unstable angina within past 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00217425
NCT00217425Phase 2Completed

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

Eastern Cooperative Oncology Group·interventional·Posted Sep 22, 2005·Updated Jun 18, 2023

In Brief

A Phase 2 clinical trial evaluating bevacizumab, cyclophosphamide, and 3 other interventions for Lymphoma. Completed, enrolled 46 participants across 110 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartSep 14, 2006
Primary CompletionApr 1, 2012
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 20.8 years ago

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.

cyclophosphamidedrug

IV infusion per institutional guidelines.

doxorubicindrug

Intravenously, either as a bolus injection or as a continuous infusion through a central venous line.

prednisonedrug

Prednisone is taken orally.

vincristinedrug

IV push using extravasation precautions.