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Adequacy of Peripheral Blood Stem Cell Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine: A Pilot Project and a Proof of Concept Study


Phase 0
18 Years
70 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

Adequacy of Peripheral Blood Stem Cell Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine: A Pilot Project and a Proof of Concept Study


Inclusion Criteria:



- Patients with relapsed or refractory C20+ non-Hodgkin's lymphoma (proven by biopsy,
radiological findings or clinical exam) referred to BMT clinic of Kansas University
Medical Center for consideration of autologous stem cell transplantation. No separate
recruitment method or advertisement will be used to enroll patients.

- Age 18-70 years.

Exclusion Criteria:

- Pregnancy and nursing mother

- Karnofsky performance status less than 50%

- 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 times 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:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the efficacy of G-CSF induced PBSC mobilization after two cycles of rituximab and Bendamustine (BR) as salvage therapy in patients with relapsed non-Hodgkins lymphoma

Outcome Time Frame:

Quarterly

Safety Issue:

Yes

Principal Investigator

Siddhartha Ganguly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Food and Drug Administration

Study ID:

11908

NCT ID:

NCT01022021

Start Date:

January 2010

Completion Date:

December 2013

Related Keywords:

  • Lymphoma
  • non-Hodgkin's lymphoma
  • autologous stem cell transplant
  • Lymphoma

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353