Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease (Rituxan+BEAM)
|ClinicalTrials.gov Identifier: NCT01702961|
Recruitment Status : Active, not recruiting
First Posted : October 10, 2012
Results First Posted : September 28, 2015
Last Update Posted : October 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Hodgkin's Disease||Drug: Melphalan Drug: Ara-C Drug: VP-16 Drug: BCNU Drug: Rituxan Drug: Stem Cells||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2018|
BEAM + R: Autologous Stem Cell Transplant
Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.
Given on Day -1
Melphalan is administered according to the current SOP.
Other Name: AlkeranDrug: Ara-C
200 mg/m2 IB BID given on Days -5, -4, -3, -2
Other Names:Drug: VP-16
200 mg/m2 IV BID given on Days -5, -4, -3, -2
Other Name: EtoposideDrug: BCNU
BCNU 300 mg/m2 IV given on Day -6
Other Name: CarmustineDrug: Rituxan
375 mg/m2 IB given on Days -6, +14, +21, +28
Other Name: RituxamibDrug: Stem Cells
Stem cells given on Day 0
- Disease-free Survival [ Time Frame: 12 months post-transplant ]Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas
- Median Days to Neutrophil Engraftment [ Time Frame: 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 [ Time Frame: 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 progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702961
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|The Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||George Carrum, MD||Associate Professor; Director-Adult Outpatient Clinic|