Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma

Stopped early · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT00057954

Run by

Eastern Cooperative Oncology Group

People needed

6

Starts

2005-11-09

Expected to finish

2011-05-01

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aurora Presbyterian Hospital — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
• St. Mary - Corwin Regional Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Tufts-NEMC Cancer Center — Boston, Massachusetts, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.