Know Cancer

forgot password

Phase II Study of Rituximab in Combination With Fludarabine and Cyclophosphamide for the Treatment of Relapsed Follicular Lymphoma

Phase 2
18 Years
70 Years
Not Enrolling
Follicular Lymphoma

Thank you

Trial Information

Phase II Study of Rituximab in Combination With Fludarabine and Cyclophosphamide for the Treatment of Relapsed Follicular Lymphoma

The natural history of follicular lymphomas is characterized by a high initial response rate
to chemotherapy followed invariably by relapse, with subsequent remissions of progressively
shorter duration. The majority of patients eventually die of their disease. As yet, there is
no gold standard for the treatment of newly diagnosed or relapsed advanced FL.Rituximab(R)
has been shown to be a highly effective agent in the treatment of FL, either alone or in
combination with chemotherapy. The ability of R to sensitize indolent lymphoma derived cell
lines to cytotoxic chemotherapy agents has been demonstrated. Furthermore, fludarabine (F)
may also sensitize cells to the effects of R. Cyclophosphamide (C) and F have shown in vivo
synergistic activity. In view of the single agent activity and demonstrated synergy between
C and F, and between F and R, we evaluated FC+R in previously treated patients with advanced
FL. The primary aim of this study was to assess the safety profile and clinical activity of
the FC+R combination. The secondary goal was to evaluate the ability of the treatment to
convert bone marrow Bcl2 positivity such that patients achieved molecular remissions.

Inclusion Criteria:

- histologically documented WHO grade 1-2 ,CD20+,follicular lymphoma

- relapsed Follicular lymphoma

- stage III or IV disease

- Stage II patients are eligible if they present with B symptoms or bulky disease

- to have a need for therapy in the opinion of treating clinician

- measurable disease

- expected survival of 6 months or more

- age 18 to 70 years

- to have undergone < 3 lines of chemotherapy

- performance status of 0 to 2

Exclusion Criteria:

- known HIV infections

- Known Hepatitis B or C

- CNS lymphoma

- previous malignancies, or cardiac, renal, hepatic, or respiratory failure

- Pregnant or lactating women and patients of child bearing potential unless using
birth control measures

Type of Study:


Study Design:

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

Outcome Measure:

Toxicity during the treatment period

Principal Investigator

Sacchi Stefano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Italy: National Bioethics Committee

Study ID:




Start Date:

March 2000

Completion Date:

August 2006

Related Keywords:

  • Follicular Lymphoma
  • follicular lymphoma
  • non-Hodgkin lymphoma
  • Fludarabine
  • Cyclophosphamide
  • Rituximab
  • combination
  • immuno-chemotherapy
  • relapsed
  • Lymphoma
  • Lymphoma, Follicular