Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease

Completed · Not applicable

Conditions studied: Lymphoma, Hodgkin's Disease

In brief

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 (recurrence of disease). For patients who did not have a complete response after traditional chemotherapy, the chance is high that the tumor will return even after high-dose chemotherapy. To improve the response and decrease the chance of relapse, doctors have used rituximab, an antibody that kills lymphoma cells, both before and after transplantation. These doctors have reported that more patients had control of the tumor for an extended period of time using rituximab with high-dose chemotherapy with autologous stem cell transplantation. How widely this is applicable is not known. The purpose of this clinical research trial is to confirm that there is a good control of tumor in patients with lymphoma or Hodgkin's disease treated with rituximab and conventional stem cell transplantation.

Key facts

Study ID

NCT01702961

Run by

Baylor College of Medicine

People needed

75

Starts

2002-06-01

Expected to finish

2017-01-01

Last updated by the study team

2018-12-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Anyone not meeting the above criteria.

Where it is running

• Texas Children's Hospital — Houston, Texas, United States
• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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