Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Extracorporeal Photopheresis; Pentostatin; Total body irradiation (TBI); Allogeneic bone marrow transplantation; Cyclosporin (CSA); Mycophenolate mofetil (MMF); Methotrexate (MTX)
Intervention description: Day -7 to -4: Extracorporeal Photopheresis may be given as an outpatient therapy on two consecutive days any time between days -7 to -4. This must be performed on UVAR or XTS photopheresis machines (Therakos, Inc.) according to standard procedure as per manufacturer's guidelines.; Day -3, -2: Pentostatin 4 mg/m²/d by continuous IV infusion (Total dose = 8 mg/m²); Day -1: TBI 400 cGy total dose given in two 200cGy doses. Patients who have received TBI for a previous transplant or radiation as part of previous treatment for a lymphoid malignancy will receive only 200 cGy in 1 dose.; Day 0: Infusion of unmanipulated allogeneic bone marrow or stem cells. Minimum cell dose of 2 x 106 CD34 cells/kg recipient and no more than 10 x 10^6 CD34/kg; Cyclosporin A or tacrolimus will be administered according to institutional GVHD prophylaxis protocols. Therapeutic levels will be maintained and patients will be switched to oral agents when they can tolerate; At day 100 MMF will be introduced at a dose of 250 mg po BID and cyclosporine or tacrolimus will be tapered according to the discretion of the investigator. The dosage will be escalated to a maximum of 2 g/d at the discretion of the attending physician and will be tapered and discontinued at 12 months if there is no active cGVHD. Doses should be given on an empty stomach; The dose of Methotrexate is based on the corrected ideal body weight for patients with > 33% above ideal weight.
Day +1 MTX 15 mg/m² IV push; Day +3 MTX 10 mg/m² IV push (May be omitted if patient develops mouth sores.)
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Methotrexate; Pentostatin; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent adult Hodgkin lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult Burkitt lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent mycosis fungoides/Sezary syndrome; recurrent adult T-cell leukemia/lymphoma; anaplastic large cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma

Summary:

      RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet (UV)
      light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune
      system and reduce the chance of developing graft-versus-host disease (GVHD) following bone
      marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation
      may be effective in killing cancer cells before bone marrow transplantation.

      PURPOSE: This phase II trial is studying how well giving photophoresis together with
      pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone
      marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's
      lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-Hodgkin's or Hodgkin's lymphoma that has relapsed following either a course of
             high dose chemotherapy or autologous stem cell transplantation.

          -  >= 90 days from prior transplant.

          -  Have a suitable human leukocyte antigen (HLA)-matched related bone marrow donor or a
             compatible matched unrelated bone marrow donor by molecular typing at HLA A, B, C, D,
             DR.

          -  Physically and psychologically capable of undergoing bone marrow transplantation and
             its attendant period of strict isolation.

          -  Age >= 18 years

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Be able to receive 400 cGy Total Body Irradiation (TBI).

          -  Pulmonary function tests: Diffusing capacity or Transfer factor of the lung for carbon
             monoxide (DLCO) >= 50% predicted, the forced expiratory volume in 1 second (FEV1) >=
             50% predicted.

          -  Left ventricular ejection fraction (LVEF) at least 45% by Multi Gated Acquisition Scan
             (MUGA) or echocardiogram.

          -  Renal function: creatinine clearance > 50 ml/min.

          -  Liver function tests: < 3 x Upper Limit of Normal (ULN). Liver function test include
             serum glutamic oxaloacetic transaminase (SGOT) (Aspartate transaminase (AST)), Serum
             Glutamic Pyruvate Transaminase (SGPT) (Alanine transaminase (ALT)), and bilirubin.

        Exclusion Criteria:

          -  Human immunodeficiency virus positive (HIV+) patients (test positive for P21
             antibodies to HIV).

          -  Evidence of active infection (have received parenteral antibiotics <= 2 weeks prior to
             registration).

          -  Pregnant or breast-feeding women.

          -  Curable with any other therapeutic interventions.