Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00096460
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT00096460
Study Brief:
Protocol Section:
NCT00096460