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

Lymphoma Clinical Trial

— Rituxan+BEAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702961
• Other study ID #: H-11892
• Secondary ID: Rituxan+BEAM
• Status: Completed
• Phase: N/A
• Start date: June 2002
• Est. completion date: January 2017

Study information

• Verified date: November 2018
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

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 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.

Patients 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2017
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Anyone not meeting the above criteria.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Lymphoma

Intervention

Drug:
• Melphalan
Given on Day -1 Melphalan is administered according to the current SOP.
• Ara-C
200 mg/m2 IB BID given on Days -5, -4, -3, -2
• VP-16
200 mg/m2 IV BID given on Days -5, -4, -3, -2
• BCNU
BCNU 300 mg/m2 IV given on Day -6
• Rituxan
375 mg/m2 IB given on Days -6, +14, +21, +28
• Stem Cells
Stem cells given on Day 0

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas
United States	The Methodist Hospital	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival	Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas	12 months post-transplant
Secondary	Median Days to Neutrophil Engraftment	Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.	30 days post-transplant
Secondary	Number of Participants With Overall Best Response Achieved After Transplantation	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 progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir.	3 months post-transplant