Clinical trial NCT00096460 (phase 2/phase 3, status: terminated)
Conditions: recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, follicular lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: cyclophosphamide and rituximab, filgrastim, non-myeloablative conditioning regimen, rituximab maintenance therapy, gvhd prophylaxis
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, N[C@@H](CCCNC(N)=N)C(O)=O, NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O, ClCCN(CCCl)P1(=O)NCCCO1, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O
Reason stopped: 
    lower than anticipated accrual
  
Eligibility 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