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Role of Rituximab Containing Salvage Chemotherapy and in Vivo Purging in Obtaining PCR Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma or Transplant Eligible Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkins Lymphoma

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Trial Information

Role of Rituximab Containing Salvage Chemotherapy and in Vivo Purging in Obtaining PCR Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma or Transplant Eligible Mantle Cell Lymphoma


Following the first relapse, patients with follicular type of Non-Hodgkin's lymphoma may
have an option to receive high dose chemotherapy followed by autologous (from you) blood
stem cell transplantation. One of the common causes of relapse is persistence of lymphoma
cells in the bone marrow and in the collected stem cell products.

Patients who do not have a complete response after traditional chemotherapy, have a greater
chance of the lymphoma returning even after receiving high dose chemotherapy with stem cell
transplantation. In order to improve the response and decrease the relapse rate, additional
therapy may be used to kill the lymphoma cells by using antibodies both before and after the
transplantation. Antibodies are protein made by white cells in our body to fight off
infection and sometimes tumor. Rituxan (rituximab) is an antibody that is effective against
your type of lymphoma. Researchers have reported that patients show an improved response and
a lower chance of relapse when using rituximab with high dose chemotherapy with autologous
stem cell transplantation. It is unknown how effective rituximab is in clearing persistence
of minimal remaining disease in patients with follicular lymphoma.


Inclusion Criteria:



- Patients with biopsy-proven refractory CD20+ Follicular lymphoma or transplant
eligible mantle cell lymphoma in CR1 or later.

- Patients must be transplant eligible per KUCC BMT SOP with chemo-sensitive/marrow
negative disease.

- Patients planning to harvest and hold may also be included as long as above criteria
are met.

Exclusion Criteria:

- Pregnancy

- Zubrod performance status greater than 2

- Life expectancy is severely limited by concomitant illness.

- Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation

- Symptomatic pulmonary disease precluding transplantation

- Serum creatinine greater than 1.8 mg/dL

- Serum bilirubin greater than 2 X upper limit of normal, SGPT greater than 3 times
upper limit of normal

- Evidence of chronic active hepatitis or cirrhosis

- Unable to sign informed consent.

- Allergy to Rituximab

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the role of Rituximab containing salvage regimens in achieving BCL2 PCR negative stem cell harvest product in patients with relapsed CD20+ follicular lymphoma or transplant eligible mantle cell lymphoma.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Siddhartha Ganguly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

11571

NCT ID:

NCT00856245

Start Date:

February 2009

Completion Date:

November 2013

Related Keywords:

  • Non-Hodgkins Lymphoma
  • non-Hodgkins
  • lymphoma
  • stem cell transplant
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353
University of Kansas Medical Center, Westwood CampusKansas City, Kansas  66205