Know Cancer

or
forgot password

A Phase II Study of Rituximab/Bendamustine Followed by Rituximab/Cytarabine for Untreated Mantle Cell Lymphoma


Phase 2
18 Years
69 Years
Open (Enrolling)
Both
Mantle Cell Lymphoma

Thank you

Trial Information

A Phase II Study of Rituximab/Bendamustine Followed by Rituximab/Cytarabine for Untreated Mantle Cell Lymphoma


Patients enrolling in this study will receive a maximum of six cycles of the study drugs.
Each cycle is 28 days in length. They will receive Rituximab-Bendamustine (RB) for the first
3 cycles. This treatment will consist of Rituximab given by infusion into a vein
(intravenous) on day 1 of each cycle and Bendamustine given by infusion into a vein (over
approximately 30-60 minutes) daily on days 1 and 2 of each cycle.

They will then receive Rituximab-Cytarabine (RC) for the last 3 cycles (with the first cycle
administered 28 days after the last RB cycle). This treatment will consist of Rituximab
given by infusion into a vein (intravenous) on day 1 of each cycle and cytarabine by
infusion into a vein (intravenous) every 12 hours on days 1 and 2 of each cycle. It is
expected that those 3 cycles will be delivered in the hospital, over 2-3 days each time.

It is expected that patients will proceed to autologous stem cell transplantation at the
conclusion of this study. However, the stem cell transplantation will not be performed as
part of this study.


Inclusion Criteria:



- Mandatory pathologic review of the diagnostic specimen(s) at Brigham and Women's
Hospital or Massachusetts General Hospital

- Measurable disease

- Candidate for ASCT

Exclusion Criteria:

- Prior anti-lymphoma therapy

- Pregnant or breastfeeding

- Hypersensitivity to rituximab

- Uncontrolled intercurrent illness

- Receiving other study agents

- HIV positive on combination antiretroviral therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete Remission rate of Rituximab/Bendamustine and Rituximab/Cytarabine

Outcome Description:

CR and CRu rate of an alternating regimen of Rituximab-Bendamustine and Rituximab-Cytarabine for adult patients younger than 70 years old with untreated MCL.

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

12-168

NCT ID:

NCT01661881

Start Date:

August 2012

Completion Date:

April 2015

Related Keywords:

  • Mantle Cell Lymphoma
  • Newly diagnosed
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617