Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma
Condition: Hodgkin's Disease; Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: bendamustine hcl
Intervention description: Patients will receive bendamustine 120mg/m^2, administered as a 30-minute infusion, for two consecutive days. Cycles will be repeated every four weeks and a total of 6 cycles will be planned. Patients will receive pegfilgrastim with each cycle. Treatment will be delayed until the absolute neutrophil count is > 1000/ul and the platelet count is > 75,000/ul.
Intervention MeSH terms: Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bendamustine HCL

Summary:

      The standard treatment for patients with HL that has not responded to treatment or has come
      back after treatment is stem cell transplant. When patients are not eligible for transplant
      or when HL comes back after transplant, there are no standard treatment options. These
      patients can receive chemotherapy or participate in clinical trials. Bendamustine HCl is a
      chemotherapy agent that is effective in treating patients with various diseases, including
      non-Hodgkin's lymphoma, multiple myeloma, and breast cancer. It was recently approved for the
      treatment of chronic lymphocytic leukemia. In addition, small studies from Eastern Europe
      have shown that bendamustine HCl is likely effective for treating HL. This study will find
      out the effect of bendamustine HCl for transplant-ineligible patients with HL that has not
      responded to or has come back after treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of Classical Hodgkin lymphoma, confirmed by the department of
             hematopathology at MSKCC. Patients who have relapsed after an autologous stem cell
             transplant must have a biopsy after transplant to confirm relapsed Hodgkin's disease.
             Patients who have relapsed after an allogeneic transplant must also have a biopsy
             posttransplant.

          -  Age > or = to 18

          -  All patients must have PET avid measurable disease.

          -  Last chemotherapy > or = to 4 weeks from the start of Bendamustine HCl

          -  Receiving no other treatment for HL

          -  Patients must have normal baseline cardiac function based upon echocardiogram or gated
             blood pool scan (MUGA) with an ejection fraction > or = to 50%

          -  Patients must have a serum creatinine of < or = to 1.5 mg/dl; if creatinine >1.5 mg/dl
             creatinine clearance must be >60 ml/minute.

          -  Patients must have ANC>1000/mcl and Platelets>100,000/mcl.

          -  Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of
             Gilbert's disease (or pattern consistent with Gilbert's).

          -  Patients must be Hepatitis B surface antigen and Hepatitis B core antibody negative
             and Hepatitis C negative.

          -  Patients must have failed an autologous stem cell transplant or be ineligible for an
             autologous stem cell transplant due to chemo-refractory disease(as defined as <50%
             response to standard salvage chemotherapy).

          -  Women who are pre-menopausal must have a negative pregnancy test

          -  Subjects must agree to use appropriate contraception until 4 weeks after the
             completion of chemotherapy.

          -  Patients must be HIV negative.

          -  If patients have a history of malignancy other than cutaneous basal cell or squamous
             cell carcinoma, they must be disease-free for ≥ 5 years at the time of enrollment.

          -  Patients or their guardians must be capable of providing informed consent.

        Exclusion Criteria:

          -  Patients with either parenchymal brain or lepto-meningeal involvement.

          -  7 or more consecutive days of prednisone therapy prior to therapy.

          -  Known pregnancy or breast-feeding.

          -  Medical illness unrelated to HL, which in the opinion of the attending physician and
             principal investigator will preclude administration of chemotherapy safely. This
             includes patients with uncontrolled infection, chronic renal insufficiency, myocardial
             infarction within the past 6 months, unstable angina, cardiac arrhythmias other than
             chronic atrial fibrillation and chronic active or persistent hepatitis

          -  History of any malignancy for which the disease-free interval is <5 years, excluding
             curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma
             in-situ of the cervix.

          -  Relapse <6 months post allogeneic stem cell transplant