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A Clinical Trial Evaluating I131-Tositumomab (Anti-CD20) With Escalating Doses of Fludarabine Followed by Autologous or Syngeneic Stem Cell Transplantation for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma in Patients 60 Years of Age and Older


Phase 1
60 Years
N/A
Open (Enrolling)
Both
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell 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, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia

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Trial Information

A Clinical Trial Evaluating I131-Tositumomab (Anti-CD20) With Escalating Doses of Fludarabine Followed by Autologous or Syngeneic Stem Cell Transplantation for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma in Patients 60 Years of Age and Older


PRIMARY OBJECTIVES:

I. To estimate the maximally tolerated dose of fludarabine that can be combined with
131I-anti-CD20 (iodine I 131 tositumomab) delivering =< 27Gy to critical normal organs
followed by autologous or syngeneic transplantation in patients >= 60 years of age with
relapsed B-NHL.

SECONDARY OBJECTIVES:

I. To assess the overall and progression-free survival of the above regimen in such
patients.

II. To evaluate the response rates of the above therapy.

III. To evaluate the toxicity and tolerability of the above therapy.

IV. To evaluate the feasibility of delivering concurrent high-dose radioimmunotherapy (RIT)
and chemotherapy.

OUTLINE: This is a dose-escalation study of fludarabine phosphate as used in combination
with I 131 tositumomab and stem cell transplant.

Patients receive a dosimetric dose of iodine I 131 tositumomab intravenously (IV) over 40-60
minutes on day -24 followed by gamma camera imaging over the next 6 days. Patients then
receive a therapeutic dose of iodine I 131 tositumomab via central line over 40-60 minutes
on day -14. Patients also receive fludarabine phosphate IV once daily (QD) on days -11 to -9
OR days -11 or -7. Patients undergo autologous or syngeneic peripheral blood stem cell
transplantation on day 0.

Patients with circulating lymphoma cells by peripheral smear receive tositumomab IV over 1
hour OR rituximab IV over 1 hour followed by tositumomab IV over 1 hour before the
dosimetric iodine I 131 tositumomab infusion.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months and
then annually thereafter.


Inclusion Criteria:



- Patients must have a histologically confirmed diagnosis of lymphoma expressing the
CD20 antigen and generally must have failed at least one prior standard systemic
therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be
enrolled while in first complete remission (CR) in accordance with current transplant
standard of care for these patients

- Creatinine (Cr) < 2.0

- Bilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert's
syndrome, whom may have a total bilirubin above 1.5 mg/dL

- All patients eligible for therapeutic study must have (>= 2x10^6 CD34/kg) autologous
hematopoietic stem cells harvested and cryopreserved, or this number of cells
harvested from a syngeneic donor

- Patients must have an expected survival of > 60 days and must be free of major
infection

- DONOR: Syngeneic donors must be confirmed syngeneic by ABO typing, human leukocyte
antigen (HLA) typing, and variable number tandem repeat (VNTR) analysis

- DONOR: Syngeneic donors must meet eligibility under Standard Practice
Guidelines/Standard Treatment

Exclusion Criteria:

- Circulating anti-mouse antibody (HAMA) (to be determined before both dosimetry and
therapy)

- Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled
therapy dose

- Inability to understand or give an informed consent

- Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord,
> 25% of red marrow)

- Central nervous system lymphoma

- Other serious medical conditions considered to represent contraindications to bone
marrow transplant (BMT) (e.g., abnormally decreased cardiac ejection fraction,
diffusing capacity (DLCO) < 50% predicted, patient on supplemental oxygen, acquired
Immunodeficiency syndrome [AIDS], etc.)

- Pregnancy

- Prior bone marrow or stem cell transplant

- South West Oncology Group (SWOG) performance status >= 2

- Unable to perform self-care during radiation isolation

- Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma/well
differentiated lymphocytic lymphoma

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose/dose limiting toxicity

Outcome Description:

Assessed according to Bearman scale for Regimen-Related Toxicities.

Outcome Time Frame:

Up to 30 days post-transplant

Safety Issue:

Yes

Principal Investigator

Ajay Gopal

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

1943.00

NCT ID:

NCT00110071

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell 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
  • Splenic Marginal Zone Lymphoma
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell

Name

Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109