Non Hodgkin Lymphoma Clinical Trial
Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin’s or Hodgkin’s 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.
Full Description
OBJECTIVES:
Determine the rate of stable engraftment of donor cells in patients with relapsed non-Hodgkin's or Hodgkin's lymphoma treated with a reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) bone marrow transplantation.
Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen.
Determine the 100-day overall survival and long-term progression-free survival of patients treated with this regimen.
Evaluate the feasibility of collection of molecular chimerism studies at baseline, days 30, 100, 6 months and one and two years and at relapse.
OUTLINE: This is a multicenter study.
Conditioning regimen: Patients undergo extracorporeal photopheresis using methoxsalen and UV light on 2 consecutive days between days -7 to -4. Patients receive pentostatin intravenously (IV) continuously on days -3 to -2 and undergo total body irradiation on day -1.
Allogeneic bone marrow transplantation: Patients undergo infusion of allogeneic bone marrow or stem cells on day 0.
Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine beginning on day -1 and continuing until 6 months after transplantation, oral mycofenolate mofetil beginning on day 100 and continuing for 1 year, and methotrexate IV on days 1 and 3.
Patients are followed at day 100, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 1.8 years.
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.
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There are 18 Locations for this study
Aurora Colorado, 80012, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80933, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80224, United States
Englewood Colorado, 80110, United States
Grand Junction Colorado, 81502, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80502, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
Jacksonville Florida, 32224, United States
Boston Massachusetts, 02111, United States
Rochester Minnesota, 55905, United States
New Brunswick New Jersey, 08903, United States
Cleveland Ohio, 44106, United States
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