A Phase I/II Trial of VR-CHOP in Lymphoma Patients

Completed · Phase 1/Phase 2

Conditions studied: Lymphoma, B-Cell, Follicular Lymphoma

In brief

This is an open-label (doctors and patients know which drug will be given), single center, phase 1/2 clinical trial. The primary objective is to determine whether VR-CHOP provides benefit to patients with previously untreated indolent non-Hodgkin's lymphomas (NHL).

Key facts

Study ID

NCT00634179

Run by

Emory University

People needed

37

Starts

2008-02-01

Expected to finish

2015-11-01

Last updated by the study team

2016-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Tissue diagnosis of a previously untreated, cluster of differentiation antigen 20+ (CD20+), B-cell non-Hodgkin lymphoma.
• For the Phase 1 trial: patients with any of the following diagnoses are eligible:
• Follicular Lymphomas (Grade 1, 2, 3a, 3b)
• Small Lymphocytic Lymphoma
• Marginal Zone Lymphomas
• For the Phase 2 trial: patients with any of the following diagnoses are eligible:
• Follicular Lymphomas (Grade 1, 2, 3a)
• Small Lymphocytic Lymphoma
• Marginal Zone Lymphomas
• Patients with follicular or other low-grade lymphoma must have an indication for treatment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria or a Follicular Lymphoma International Prognostic Index (FLIPI) score ≥ 3.
• Indications for treatment based on modified GELF criteria include any one of the following:
• B symptoms or other lymphoma-related symptoms
• Involvement of 3 nodal sites, each with a diameter of 3 cm
• Any nodal or extranodal tumor mass with a diameter of 7 cm
• Splenomegaly greater than 16 cm by CT scan.
• Pleural effusions or peritoneal ascites
• Cytopenias (leukocytes < 1.0 x 10 /L and/or platelets < 100 x 10/L)
• Leukemia (> 5.0 x 10 /L circulating malignant cells)
• Indications for treatment based on FLIPI criteria include any three of the following:
• Age ≥ 60 years
• Ann Arbor stage III or IV
• Hemoglobin level < 120 g/L
• Number of nodal areas involved > 4
• Serum lactate dehydrogenase (LDH) level > normal
• Only chemotherapy-naïve subjects are eligible. Subjects may have received prednisone (< 2 months of therapy) or radiation ≤ 2 sites of therapy.

You may not qualify if…

• Subject with primary or secondary central nervous system (CNS) lymphoma (current or previously treated) will not be eligible.
• A history of unrelated (non-lymphomatous) neoplasm within the past 10 years other than non-melanoma skin cancer or in-situ cervix cancer. Subjects with a prior diagnosis of malignancy more than 10 years may be entered into the study at the discretion of the Principal Investigator.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Patient has received other investigational drugs with 14 days before enrollment.
• Patient has hypersensitivity to boron or mannitol.
• Female subject is pregnant or breast-feeding. Chemotherapeutic agents are known to have teratogenic effects on developing embryos and to cause chromosomal damage to gametes. These agents also cause bone marrow suppression and can be excreted in milk. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
• Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
• Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
• Patient has a platelet count of < 10 x 10¹⁰/L (unless due to bone marrow involvement with lymphoma documented within 14 days before enrollment).
• Patient has an absolute neutrophil count of < 1.0 x 10⁹/L (unless due to bone marrow involvement with lymphoma documented within 14 days before enrollment).
• Patient has a calculated or measured creatinine clearance of < 20 mL/minute within 14 days before enrollment.
• Presence of antibodies to HIV.
• Subject unwilling to give informed consent.

Where it is running

• Emory University Winship Cancer Institute — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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