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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
George Carrum, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01702961
First received: October 5, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention
Lymphoma
Hodgkin's Disease
Drug: Melphalan
Drug: Ara-C
Drug: VP-16
Drug: BCNU
Drug: Rituxan
Drug: Stem Cells

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Disease-free survival at 12 months post transplant [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: June 2002
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
BEAM + R: Autologous Stem Cell Transplant
Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning
Drug: Melphalan

Given on day -1

Melphalan is administered according to the current SOP.

Other Name: Alkeran
Drug: Ara-C
200 mg/m2 IB BID given on days -5, -4, -3, -2
Other Names:
  • Cytarabine
  • Cytosar-u
Drug: VP-16
200 mg/m2 IV BID given on days -5, -4, -3, -2
Other Name: Etoposide
Drug: BCNU
BCNU 300mg/m2 IV given on day -6
Other Name: Carmustine
Drug: Rituxan
375 mg/m2 IB given on days -6, +14, +21, +28
Other Name: Rituxamib
Drug: Stem Cells
Stem cells given on day 0

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 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702961

Locations
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Investigators
Principal Investigator: George Carrum, MD Associate Professor; Director-Adult Outpatient Clinic
  More Information

No publications provided

Responsible Party: George Carrum, Associate Professor; Director-Adult Outpatient Clinic, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01702961     History of Changes
Other Study ID Numbers: H-11892, Rituxan+BEAM
Study First Received: October 5, 2012
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Lymphoma
Hodgkin's Disease

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Carmustine
Melphalan
Rituximab
Cytarabine
Etoposide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Myeloablative Agonists
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 24, 2014