Status:
TERMINATED
Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Blood and Marrow Transplant Clinical Trials Network
Conditions:
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
BACKGROUND: Although patients with follicular non-Hodgkin's lymphoma (NHL) typically experience a relatively indolent course, the disease is rarely curable with conventional chemotherapy. Patients wi...
Eligibility Criteria
Inclusion
- Initial Patient
- 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:
- Cardiac: left ventricular ejection fraction at rest at least 45%
- 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
- Renal: creatinine clearance greater than 40 mL/min
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00096460
Start Date
August 1 2004
End Date
March 1 2009
Last Update
January 5 2023
Active Locations (30)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
2
Scripps Clinic
La Jolla, California, United States, 92037
3
UCSD Medical Center
La Jolla, California, United States, 92093
4
Stanford Hospital and Clinics
Stanford, California, United States, 94305