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A Phase II Trial Of BEAM/Rituximab/Autologous Hematopoietic Stem Cell Transplantation (AHSCT) For Patients With CD20 Positive Non-Hodgkin's Lymphoma


Phase 2
19 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase II Trial Of BEAM/Rituximab/Autologous Hematopoietic Stem Cell Transplantation (AHSCT) For Patients With CD20 Positive Non-Hodgkin's Lymphoma


OBJECTIVES:

- Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after
treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed
by autologous hematopoietic stem cell transplantation in patients with CD20-positive
B-cell non-Hodgkin's lymphoma.

- Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients
treated with this regimen.

- Determine the response rate in patients treated with this regimen.

- Determine the event-free survival of patients treated with this regimen.

- Determine the toxicity profile of this regimen in these patients.

OUTLINE: Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks
followed 1 week later by hematopoietic stem cell or bone marrow harvest.

Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or
-6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6,
cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1.
Patients undergo autologous hematopoietic stem cell transplantation on day 0.

Patients who have less than a complete remission at day 100 post-transplantation receive 4
additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks.

Patients are followed at day 100, at 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of non-Hodgkin's lymphoma

- Any B cell

- CD20-positive disease

- Failed prior primary induction therapy

- Meets 1 of the following criteria:

- Chemotherapy-refractory disease

- Received at least 3 prior chemotherapy regimens

- Mantle cell lymphoma

- Eligible for transplantation

- No history of T-cell lymphoma

PATIENT CHARACTERISTICS:

Age

- 19 and over

Performance status

- WHO 0-2

Life expectancy

- At least 6 months

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3*

- Platelet count > 50,000/mm^3*

- Hemoglobin > 9.0 g/dL* NOTE: *Unless due to lymphomatous involvement of the bone
marrow

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant or nursing

- Fertile patients must use 2 methods of effective contraception

- No other concurrent serious disease or condition that would preclude study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

evaluation of the relationship between levels of sCD20 in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous peripheral blood progenitor cell transplantation (PBPCT) as they relate to clinical outcomes.

Outcome Description:

To evaluate levels of soluble CD20 antigen (sCD20) in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous hematopoietic stem cell transplantation (AHSCT), and to examine the effect of changes in levels of sCD20 with clinical outcomes.

Outcome Time Frame:

pre and post transplant

Safety Issue:

No

Principal Investigator

Robert G Bociek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Federal Government

Study ID:

UNMC-06302

NCT ID:

NCT00080886

Start Date:

February 2004

Completion Date:

January 2015

Related Keywords:

  • Lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680