Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF(Granulocyte-macrophage Colony-stimulating Factor) and Rituximab
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Mitoxantrone/Cyclophosphamide, Fludarabine, Rituximab and GM-CSF
Intervention description: Initial patients (n=9) received fludarabine (25 mg/m^2 intravenously) and mitoxantrone (10 mg/m^2 intravenously)with sequential administration of GM-CSF(Granulocyte-macrophage colony stimulating factor) (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m^2) on day 8.
After a change in the protocol, all additional patients (n=6) received fludarabine (25 mg/m^2 intravenously) and cyclophosphamide (250 mg/m^2 intravenously)with sequential administration of GM-CSF (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m^2) on day 8. All patients received additional doses of GM-CSF (days +8 through +14) were given for patients to reduce variability in neutropenic management.
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine; Mitoxantrone; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma

Summary:

      Patients with a low-grade, or indolent (slow-growing) form of non-Hodgkin's lymphoma (NHL) in
      which the usual survival is between 7-10 years are being asked to take part in this study.
      Although normally-used combinations of chemotherapy will cause NHL to disappear in 30-40% of
      patients (called complete response or complete remission), almost all will have their disease
      return.

      In this study, researchers tested a combination of anti-cancer agents, fludarabine, rituximab
      and GM-CSF with mitoxantrone or cyclophosphamide to see if a better and more long-lasting
      response can be achieved. All of the medications are approved by the Food and Drug
      Administration (FDA) and are available on the market. The agents we will use are:

        -  Mitoxantrone and fludarabine and cyclophosphamide and fludarabine are combinations of
           chemotherapy drugs that have been successfully used to treat NHL/CLL (Chronic
           lymphocytic leukemia) that has returned after treatment and are comparable options for
           treatment.

        -  Rituximab, a monoclonal antibody that kills cancer cells by binding the CD20 antigen
           found on the surface of B-cells, commonly used along with chemotherapy drugs to improve
           response rates in lymphoma treatment.

        -  GM-CSF (granulocyte-macrophage colony stimulating factor, also called sargramostim, GM,
           or Leukine), a growth factor which stimulates the development of new ("stem") cells.
           GM-CSF encourages stem cells to divide, specialize, and become active. It is not a
           normal part of treatment for NHL.

      Using GM-CSF in NHL treatment is the experimental part of this study. The main purpose of
      this study is to see if giving GM-CSF along with a standard anti-cancer treatment will work
      better to reduce cancer, and to look at side effects of the treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  To qualify for this study, the patient must have relapsed, refractory or previously
             untreated low-grade (indolent) non-Hodgkin lymphoma of the following subtypes:
             Follicular center cell lymphoma grade 1, lymphoplasmacytoid lymphoma, small
             lymphocytic lymphoma, splenic marginal-zone types lymphoma, monocytoid B-cell lymphoma
             and extranodal mucosa-associated lymphoid tissue (MALT) lymphomas. Final eligibility
             will be determined by the health professionals conducting this clinical trial.

        Exclusion Criteria:

          -  Patients who have received prior treatment with purine analogs will be excluded from
             this study. Also, patients whose diagnostic/histologic subtype cannot be confirmed by
             our institution will not be able to participate in this study. Final eligibility will
             be determined by the health professionals conducting this clinical trial.