A Current Practice Study of Rituxan in Patient Receiving BEAM Chemotherapy and Autologous Blood Stem Cell Transplantation for High Risk Lymphoma or Hodgkin's Disease
N/A
N/A
Both
Lymphoma, Hodgkin's Disease
Trial Information
A Current Practice Study of Rituxan in Patient Receiving BEAM Chemotherapy and Autologous Blood Stem Cell Transplantation for High Risk Lymphoma or Hodgkin's Disease
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 cytosine
arabinoside, and melphalan. BCNU is given on the first day, Ara-C and VP-16 on the second,
third, fourth and fifth days, and melphalan on the sixth day. The infusion of blood stem
cells is given through the catheter the day after the last dose of chemotherapy. This is
called Day 0. A week later the subject will receive shots under the skin of Neupogen to help
the stem cells grow quickly. Three additional doses of rituximab are given weekly starting 2
weeks later. If the subject recovers and is discharged from the hospital before getting all
the doses of rituximab, they can receive the remainder in clinic.
Patient's will remain in the hospital for approximately 3-4 weeks and in the Houston area
for about 30 days from the infusion of the donor cells. The patient will have blood, urine,
bone marrow, and X-ray examinations performed as necessary to monitor the results of
treatment. They will have blood tests daily while hospitalized.
As an outpatient the patient will be monitored to make sure their immune system (system in
the body that helps protect the body and fights bacterial, viral and fungal infections) is
recovering, and the patient may require additional infusions of immunoglobulins
(infection-fighting blood proteins) until the blood protein levels are safe. The patient
will also be taking antibiotic pills for about 6 months to prevent infections. They will
have X-rays and other diagnostic tests (PET scans) every 6-12 months during the next 5 years
to make sure the tumor stays under control.
Inclusion Criteria:
- Patients with biopsy-proven, relapsed, or refractory CD20+ lymphoma, or HD.
- At least 2 e6 CD34/kg autologous PBSC stored. If patients are nonmobilizers, then at
least 2 e8 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 2 X upper limit of normal, SGPT less than or
equal to 3 X 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.
Exclusion Criteria:
- Anyone not meeting the above criteria.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival at 12 months post transplant
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
George Carrum, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Associate Professor; Director-Adult Outpatient Clinic
Authority:
United States: Food and Drug Administration
Study ID:
H-11892
NCT ID:
NCT01702961
Start Date:
June 2002
Completion Date:
October 2018
Related Keywords:
- Lymphoma
- Hodgkin's Disease
- Lymphoma
- Hodgkin's Disease
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Texas Children's Hospital | Houston, Texas |
| The Methodist Hospital | Houston, Texas 77030 |
