Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease
- Conditions
- Interventions
- Registration Number
- NCT01702961
- Lead Sponsor
- Baylor College of Medicine
- Brief Summary
High-dose chemotherapy followed by autologous (the patient's own) peripheral blood (circulating blood) stem cell (cells that divide to form white cells, red cells and cells that help clot) transplantation is a conventional treatment for patients with lymphoma (cancer of lymph glands) and Hodgkin's disease (cancer of lymph glands) after first relapse (recurre...
- Detailed Description
Subjects will receive the chemotherapy through a plastic tube (catheter) placed into a vein under the collarbone. The antibody rituximab is given on the day of admission. The subject will also start a six-day course of chemotherapy at that time. The chemotherapy will consist of the following drugs: BCNU, etoposide also called VP-16, Ara-C also called cytosin...
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Patients with biopsy-proven, relapsed, or refractory CD20+ lymphoma, or HD.
- At least 2e6 CD34+/kg autologous PBSC stored. If patients are non-mobilizers, then at least 2e8 TNC/kg autologous marrow should be stored.
- Patient is not pregnant.
- Zubrod performance status less than or equal to 2.
- Life expectancy is not severely limited by concomitant illness.
- Left ventricular ejection fraction greater than or equal to 50%.
- No uncontrolled arrhythmias or symptomatic cardiac disease.
- FEV1, FVC and DLCO greater than or equal to 50%.
- No symptomatic pulmonary disease.
- Serum creatinine less than or equal to 1.5 mg/dL.
- Serum bilirubin less than or equal to 2X upper limit of normal, SGPT less than or equal to 3X upper limit of normal.
- No evidence of chronic active hepatitis or cirrhosis.
- No effusion or ascites greater than or equal to 1L prior to drainage.
- HIV negative.
- Patient or guardian able to sign informed consent.
- Patients of any age may be enrolled on this protocol.
- Anyone not meeting the above criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BEAM+R: Autologous Stem Cell Transplant BCNU Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM+R: Autologous Stem Cell Transplant Melphalan Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM+R: Autologous Stem Cell Transplant Rituxan Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM+R: Autologous Stem Cell Transplant Stem Cells Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM+R: Autologous Stem Cell Transplant VP-16 Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM+R: Autologous Stem Cell Transplant Ara-C Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells
- Primary Outcome Measures
Name Time Method Disease-free Survival 12 months post-transplant Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas
- Secondary Outcome Measures
Name Time Method Median Days to Neutrophil Engraftment 30 days post-transplant Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10\^9/L for three consecutive readings.
Number of Participants With Overall Best Response Achieved After Transplantation 3 months post-transplant Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (\>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or ...
Trial Locations
- Locations (2)
The Methodist Hospital
🇺🇸Houston, Texas, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States