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A Phase II Study of VcR-CVAD With Rituximab Maintenance for Untreated Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Contiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Stage I Mantle Cell Lymphoma, Stage III Mantle Cell Lymphoma, Stage IV Mantle Cell Lymphoma

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Trial Information

A Phase II Study of VcR-CVAD With Rituximab Maintenance for Untreated Mantle Cell Lymphoma


PRIMARY OBJECTIVES:

I. To evaluate the CR rate in patients with mantle cell lymphoma, who are treated with
VcR-CVAD.

SECONDARY OBJECTIVES:

I. To evaluate the overall response rate to VcR-CVAD. II. To evaluate the PFS and OS of
patients receiving maintenance rituximab after VcRCVAD induction.

III. To evaluate the PFS and OS of patients who receive autologous stem cell transplantation
after VcR-CVAD induction.

IV. To evaluate the toxicity of VcR-CVAD.

TERTIARY OBJECTIVES:

I. Evaluation of antigen expression patterns to determine or confirm possible unique
expressions of MCL.

II. To evaluate the percentage of circulating MCL cells.

OUTLINE: This is a multicenter study.

Induction therapy (VcR-CVAD): Patients receive VcR-CVAD comprising bortezomib IV over 3-5
seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV
over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3;
vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days
1-4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or IV once daily beginning
on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

Maintenance therapy: Beginning 4-8 weeks after completion of induction therapy, patients
receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6
months for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of induction therapy, patients who are eligible may have the option to
receive consolidation therapy for autologous stem cell transplantation (off-study). These
patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy.

After completion of study treatment, patients are followed periodically for up to 10 years.


Inclusion Criteria:



- Patients must have a histologically confirmed diagnosis of mantle cell lymphoma by
demonstrating appropriate morphology plus at least one of the following on the biopsy
specimen: nuclear cyclin D1+ by imunohistochemistry; t(11;14) by FISH, PCR, or
conventional karyotyping

- No prior chemotherapy, immunotherapy or radiotherapy for mantle cell lymphoma; a
brief course of steroids (< 14 days) for symptom relief or steroids for other
indications are allowed

- Patients must have measurable disease; CT scans at baseline are required to define
the extent of measurable disease; the scans must be obtained within 6 weeks prior to
registration; combined CT/PET scans may be used for the baseline and subsequent
evaluations if accurate tumor measurements can be obtained from the CT component

- ECOG performance status 0-2

- ANC > 1500 mm^3 (unless low count due to marrow involvement or splenomegaly)

- Platelets > 100,000 mm^3 (unless low counts due to marrow involvement or
splenomegaly)

- Creatinine < 2 mg/dL

- Bilirubin < 2 mg/dL (may be up to 3.0 mg/dL if due to Gilbert's disease or due to
liver involvement by lymphoma)

- Patients over the age of 45 must have a LVEF of greater than 45% documented within 90
days prior to registration

- No known HIV disease; an HIV test is not required for entry on study but is required
if the patient is perceived to be at risk; patients with a history of intravenous
drug use or any other behavior with an increased risk for HIV infection should be
tested for exposure to the HIV virus; patients with known HIV are excluded since the
immunocompromised state of patients with HIV infection or the concomitant use of
HAART therapy may result in more extensive dose modifications than intended for the
intensive therapeutic regimen used in this study

- Patients must be tested for Hepatitis B surface antigen within 4 weeks prior to
registration NOTE: HBs Ag positive patients are not excluded but will have more
stringent monitoring of LFTs

- Women must not be pregnant or breast-feeding due to the detrimental effects
chemotherapy may have on the developing fetus or infant; all females of childbearing
potential must have a blood test or urine study within 2 weeks prior to registration
to rule out pregnancy

- Women of childbearing potential and sexually active males must use an accepted and
effective method of contraception

- Patient must not have grade 2 or higher baseline peripheral neuropathy

- Patient must not have known hypersensitivity to boron or mannitol

- Patient may not have a history of prior malignancy unless at least one of the
following conditions are met:

- Malignancy was in-situ

- Malignancy was treated surgically or with local XRT with curative intent and the
patient has been disease free for > 3 years

- Any adjuvant hormonal therapy must have been discontinued > 3 months prior to
registration

- Patients must not have known CNS involvement

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of CR defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy

Outcome Time Frame:

Up to 10 years

Safety Issue:

No

Principal Investigator

Brad Kahl

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02966

NCT ID:

NCT00433537

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Contiguous Stage II Mantle Cell Lymphoma
  • Noncontiguous Stage II Mantle Cell Lymphoma
  • Stage I Mantle Cell Lymphoma
  • Stage III Mantle Cell Lymphoma
  • Stage IV Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Eastern Cooperative Oncology GroupBoston, Massachusetts  02215