Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed as a Phase II/III, multi-center trial, comparing two transplant strategies to determine whether non-myeloablative allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will improve long-term progression-free survival compared to autologous HSCT. Recipients will be biologically assigned to the appropriate treatment arm depending on the availability of a Human Leukocyte Antigen (HLA) matched sibling.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Collaborators: Blood and Marrow Transplant Clinical Trials Network; National Cancer Institute (NCI); National Heart, Lung, and Blood Institute (NHLBI); National Marrow Donor Program
• Treatments: Carmustine; Cyclophosphamide; Etoposide; Fludarabine; Fludarabine phosphate; Lenograstim; Methotrexate; Rituximab; Tacrolimus

Criteria

Initial Patient Inclusion Criteria:

• Histologically confirmed recurrent Revised European American Lymphoma (REAL) classification follicle center lymphoma, follicular grades I and II, OR histologically confirmed World Health Organization (WHO) classification follicular lymphoma grades 1, 2, 3a or 3b; for either classification, the diffuse component or presence of large cleaved cells (if present) cannot be more than 50% of high power field; patients do not have to express t(14;18) to be eligible

• Received three or fewer prior regimens of chemotherapy; monoclonal antibody therapy and involved field radiation therapy will not be counted as a prior therapy

• Beyond first Complete Remission (CR) or first Partial Remission (PR) AND demonstrate chemosensitive disease; chemosensitive disease will be defined as less than 20% bone marrow involvement in the aspirate or core biopsy with follicular lymphoma AND lymph node size in axial diameter of less than 3 cm or a greater than 50% reduction in estimated lymph node volume to be measured as product of bi-dimensional measurements; Positron Emission Tomography (PET) scanning will not be used for staging or response purposes

• Patients with adequate organ function as measured by:

1. Cardiac: left ventricular ejection fraction at rest at least 45%

2. Hepatic: bilirubin less than 2 times the upper limit of normal and alanine transaminase (ALT) and aspartate aminotransferase (AST) less than 3 times the upper limit of normal

3. Renal: creatinine clearance greater than 40 mL/min

4. Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), Forced expiratory volume in one second (FEV1), and Forced vital capacity (FVC) greater than 50% of predicted (corrected for hemoglobin)

• If the patient is younger than 18 years of age and they have reached the age of assent, then they must have completed the local Institutional Review Board (IRB) assent process.

• Able to receive cyclophosphamide and rituximab mobilization chemotherapy no earlier than 3 weeks from the beginning of the most recent cycle of salvage chemotherapy and no later than 6 weeks from enrollment

Patient Inclusion Criteria for Proceeding to Hematopoietic Stem Cell Transplant (HSCT):

• Collection of an autologous or allogeneic graft of at least 2.0 * 10^6 CD34+ cells/kg

• Blood count recovery defined as Absolute Neutrophil Count (ANC) greater than 1000/mm3 and platelets greater than 100 * 10^9/L

Patient Inclusion Criteria for Maintenance Therapy:

• Liver and renal function tests within the inclusion criteria for initial autograft

• Off intravenous antibiotics and off amphotericin B formulations for proven, probable or possible fungal infections

• No active Cytomegalovirus (CMV) infections or for patients with CMV infection post-autograft, treated with ganciclovir, valganciclovir, or foscarnet per institutional guidelines and CMV antigenemia negative

• Mucositis resolved and off hyperalimentation

Exclusion Criteria:

• Karnofsky performance score less than 70%

• Follicular lymphoma that show histologic evidence of transformation

• Uncontrolled hypertension

• Patients with uncontrolled bacterial, viral or fungal infection (currently taking medication and progression without clinical improvement).

• Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent more than 5 years previously will be reviewed on a case-by-case basis by a Protocol Chair or Medical Monitor.

• Pregnant (positive Beta Human chorionic gonadotropin (β-HCG)) or breastfeeding

• Seropositive for Human immunodeficiency virus (HIV)

• Unwilling to use contraceptive techniques during treatment

• Prior autologous or allogeneic HSCT

• Known anaphylactic reaction to rituximab