Autologous Versus Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Patients With Chemosensitive Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response or First Partial Response (BMT CTN #0202)

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