Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma

Conditions

• 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bortezomib — DRUG
  Given IV
• rituximab — BIOLOGICAL
  Given IV
• cyclophosphamide — DRUG
  Given IV
• doxorubicin hydrochloride — DRUG
  Given IV
• vincristine — DRUG
  Given IV
• dexamethasone — DRUG
  Given IV
• filgrastim — BIOLOGICAL
  Given SC
• pegfilgrastim — BIOLOGICAL
  Given SC
• Autologous stem cell transplantation (ASCT) — PROCEDURE

Study Details

This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib works in treating patients with untreated mantle cell lymphoma. Monoclonal antibodies, such as rituximab, 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Treatment consists of six agents: bortezomib (Vc), rituximab (R), cyclophosphamide (C), vincristine (V), doxorubicin (A), and dexamethasone (D) (VcR-CVAD).

Key Dates

Start date

May 31, 2007

Status verified

Jan 2014

Primary completion

Jun 30, 2013

Completion

Jun 30, 2013

Study Design

Enrollment

77 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: VcR-CVAD induction followed by maintenance rituximab
  VcR-CVAD induction: 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 rituximab: 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.
• Experimental: VcR-CVAD induction followed by ASCT
  VcR-CVAD induction: 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) 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. ASCT: 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.

Primary Outcome Measure

Complete Response (CR) Rate [ Time Frame: Assessed after VcR-CVAD cycles 2, 4, and 6. ]

Locations (1)

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