At a glance
ClinicalIndex Comparison Record- ✓Karnofsky performance status >80% (or >60% if poor performance status is attributable to lymphoma)
- ✓Histologically confirmed non-Hodgkin's lymphoma that is chemotherapy-sensitive, including SLL/CLL, follicular, DLBCL, mantle cell, Burkitt's, or lymphoblastic subtypes
- ✓Histologically proven Hodgkin's lymphoma with failure of prior therapy
- ✓No serious organ dysfunction not attributable to tumor (CNS involvement by lymphoma is allowed)
- ✕Chemotherapy-resistant disease
- ✕Patients eligible for any higher priority transplant protocols
- ✕Serious uncontrolled infections at the time of transplant
- ✕Pregnant or breast-feeding women
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Autologous Peripheral Blood Stem Cell Transplant for Patients With Lymphoma
In Brief
A Phase 2 clinical trial evaluating carmustine, cyclophosphamide, and 5 other interventions for Lymphoma. Completed, enrolled 473 participants across 1 site.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. More radiation therapy is given after transplant to kill any remaining cancer cells. PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.
Study Details
Timeline
Interventions
Day -6, 300 mg/m\^2 over 2 hour
NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days. HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m\^2 over 2 hours daily x 4 days. Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing.
NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2. HL without radiation: 150 mg/m\^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4.
Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5.
Patients undergo total body irradiation (TBI) twice daily on days -4 to -1. * \> 1000 cGy to whole lung, kidney, or abdominal bath. * \> 3000 cGy to spinal cord, myocardium, mediastinum, lumbar periaortic lymph nodes. * \> 3600 cGy to whole brain.
Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size. Continue G-CSF until absolute neutrophil count (ANC) \> 1500/μl x 3 consecutive days. If ANC falls \<1000/μL, restart G-CSF.
100 mg/m\^2 over one hour BID on days -6 through -2 of BEAM conditioning regimen.