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A Phase I/II Trial of VR-CHOP for Patients With Untreated Follicular Lymphoma and Other Low Grade B-Cell Lymphomas


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, B-Cell, Follicular Lymphoma

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Trial Information

A Phase I/II Trial of VR-CHOP for Patients With Untreated Follicular Lymphoma and Other Low Grade B-Cell Lymphomas


This study will assess whether adding bortezomib (Velcade) to R-CHOP (in a new combination
called VR-CHOP) can further improve outcomes in patients with indolent NHL who have not
previously received treatment.

Patients who are eligible to take part in the study will receive VR-CHOP at the doses of
Velcade and vincristine established in phase 1. Patients will receive VR-CHOP for up to 8
cycles of treatment (each of 21 days duration). During treatment, patients will be assessed
for their response to therapy and for possible side effects. All patients will go on to
receive maintenance therapy after completion of their initial treatment as designed by the
protocol.


Inclusion Criteria:



• Tissue diagnosis of a previously untreated, 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 GELF criteria or a 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

- 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 LDH level >normal

- Only chemotherapy-naïve subjects are eligible. Subjects may have received prednisone
(< 2 months of therapy) or radiation ≤ 2 sites of therapy.

- Voluntary written informed consent and HIPAA Authorization before performance of any
study-related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the subject at any time without prejudice to future
medical care.

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study.

- Female patients of child bearing potential must have a negative beta-HCG test.

- Male subject agrees to use an acceptable method for contraception for the duration of
the study.

- ≥18 years of age at the time of registration

- Patients must have adequate renal function as demonstrated by a serum creatinine <
1.5 mg/dl unless felt to be secondary to lymphoma

- Must have an ALT/AST ≤ 3.5 the upper limit of normal and a total bilirubin ≤2.0 mg/dL
unless secondary to lymphoma.

- Must have a cardiac left ventricular ejection fraction ≥50%.

- At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and
greater than 1.0 cm in the short axis)

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

- Life expectancy of greater than one year.

Exclusion Criteria:

- Subject with primary or secondary 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 (see section 8.4), 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.

- Failure to meet any of the eligibility criteria in Section 3.2.1.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To identify the maximal tolerated doses of bortezomib and vincristine when used in combination of bortezomib, rituximab and the CHOP chemotherapy regimen

Outcome Time Frame:

Cycle 1 for MTD, following completion of therapy for CR

Safety Issue:

Yes

Principal Investigator

Christopher Flowers, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University

Authority:

United States: Institutional Review Board

Study ID:

IRB# 29960007

NCT ID:

NCT00634179

Start Date:

February 2008

Completion Date:

February 2014

Related Keywords:

  • Lymphoma, B-Cell
  • Follicular Lymphoma
  • Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, B-Cell

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322