Umbilical Cord Blood NK Cells, Rituximab, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma
Condition: Mantle Cell Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Follicular Lymphoma; Recurrent Indolent Adult Non-Hodgkin Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Refractory Follicular Lymphoma; Refractory Indolent Adult Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Recurrence
Intervention: Autologous Hematopoietic Stem Cell Transplantation; Carmustine; Cord Blood-derived Expanded Allogeneic Natural Killer Cells; Cytarabine; Etoposide; Filgrastim; Lenalidomide; Melphalan; Rituximab
Intervention description: Undergo stem cell transplant; Given IV; Given IV; Given IV; Given IV; Given SC; Given PO; Given IV; Given IV
Intervention MeSH terms: Cytarabine; Rituximab; Antineoplastic Agents, Immunological; Etoposide; Lenalidomide; Etoposide phosphate; Melphalan; Mechlorethamine; Carmustine; Podophyllotoxin; Nitrogen Mustard Compounds; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 15 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects of cord blood-derived expanded allogeneic
      natural killer cells (umbilical cord blood natural killer [NK] cells), rituximab, high-dose
      chemotherapy, and stem cell transplant in treating patients with B-cell non-Hodgkin's
      lymphoma that has come back (recurrent) or that does not respond to treatment (refractory).
      Immune system cells, such as cord blood-derived expanded allogeneic natural killer cells, are
      made by the body to attack foreign or cancerous cells. Immunotherapy with rituximab, may
      induce changes in body's immune system and may interfere with the ability of tumor cells to
      grow and spread. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide,
      lenalidomide, melphalan, and rituximab, work in different ways to stop the growth of cancer
      cells, either by killing the cells, by stopping them from dividing, or by stopping them from
      spreading. A stem cell transplant using stem cells from the patient or a donor may be able to
      replace blood-forming cells that were destroyed by chemotherapy used to kill cancer cells.
      The donated stem cells may also replace the patient's immune cells and help destroy any
      remaining cancer cells. Giving cord blood-derived expanded allogeneic natural killer cells,
      rituximab, high-dose chemotherapy, and stem cell transplant may work better in treating
      patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with B-cell lymphoma who are candidates to autologous stem-cell
             transplantation:

               -  Primary refractory or relapsed diffuse large B-cell lymphoma in response to
                  salvage treatment

               -  Primary refractory or relapsed follicular lymphoma or other indolent B-cell
                  histology in response to salvage treatment

               -  Chemosensitive mantle-cell lymphoma in first or later line of treatment

          -  Estimated serum creatinine clearance >= 60 ml/min and a normal serum creatinine for
             age

          -  Serum glutamic-oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate
             transaminase (SGPT) =< 3 x upper limit of normal (ULN)

          -  Total bilirubin and alkaline phosphatase (ALP) =< 2 x ULN or =< 3 x ULN for Gilbert's
             disease

          -  Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and
             diffusion lung capacity (DLCO) (corrected for hemoglobin [Hgb]) >= 50% of the
             predicted value

          -  Left ventricular ejection fraction >= 40%. No uncontrolled arrhythmias or symptomatic
             cardiac disease

          -  Performance status < 2 (Eastern Cooperative Oncology Group [ECOG])

          -  Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential

        Exclusion Criteria:

          -  Primary central nervous system (CNS) lymphoma

          -  Grade >= 3 non-hematologic toxicity from prior therapy that has not resolved to =<
             grade (G) 1

          -  Prior whole brain irradiation

          -  Active hepatitis B, either active carrier (hepatitis B surface antigen positive [HBsAg
             +]) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000
             copies/mL, or >= 2,000 IU/mL)

          -  Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic
             hepatitis C or positive hepatitis C serology

          -  Active infection requiring parenteral antibiotics

          -  Human immunodeficiency virus (HIV) infection

          -  Radiation therapy in the month prior to enroll

          -  Breastfeeding females