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A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan (Anti-CD20) Antibody With Fludarabine, Low-Dose Total Body Irradiation (TBI) and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
B-cell Chronic Lymphocytic Leukemia, 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 Grade III Lymphomatoid Granulomatosis, 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, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia

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Trial Information

A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan (Anti-CD20) Antibody With Fludarabine, Low-Dose Total Body Irradiation (TBI) and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma


PRIMARY OBJECTIVES:

I. To assess the feasibility, safety, and potential efficacy of treating patients with
B-Cell non-Hodgkin lymphoma (NHL) with 90Y-ibritumomab tiuxetan, combined with HLA-matched
related or unrelated donor hematopoietic cell transplantation.

OUTLINE: Patients receive rituximab intravenously (IV) followed by, no more than 4 hours
later, indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day -21.
Patients undergo gamma camera imaging on day -19. Patients receive rituximab IV followed by,
no more than 4 hours later, yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14.
Patients also receive fludarabine phosphate IV over 30-60 minutes on days -7 to -5 and
undergo low-dose total-body irradiation (TBI) on day 0. After TBI, patients undergo
allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients who undergo
PBSCT from a related donor receive oral cyclosporine twice daily on days -3 to 56 followed
by a taper to day 180 in the absence of graft-versus-host disease (GVHD). These patients
also receive oral mycophenolate mofetil twice daily on days 0 to 27. Patients who undergo
PBSCT from an unrelated donor receive oral cyclosporine twice daily on days -3 to 100
followed by a taper over 11 weeks in the absence of GVHD. These patients also receive oral
mycophenolate mofetil three times daily on days 0 to 40 followed by a taper to day 96.

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 a lymphoid malignancy
expressing the cluster of differentiation (CD)20 antigen and have failed at least one
prior standard systemic therapy

- Patients must have evidence of persistent lymphoma by physical examination,
radiographic studies, bone marrow evaluation, flow cytometry, or polymerase chain
reaction (PCR)

- Creatinine < 2.0

- Bilirubin < 1.5 mg/dL

- Patients must have an expected survival of > 60 days and must be free of major
infection including human immunodeficiency virus (HIV)

- Patients must have an HLA-identical related or unrelated donor

- DONOR: Donor eligibility includes both HLA-matched relatives or HLA matched,
unrelated volunteer donors; related donors should be matched by molecular methods at
the intermediate resolution level at HLA-A, B, C, and DRB1 according to FHCRC
Standard Practice Guidelines and to the allele level at DQB1; unrelated donors should
be identified using matching criteria that follows the FHCRC Standard Practice
Guidelines limiting the study to eligible donors that are allele matched for HLA-A,
B, C, DRB1, and DQB1 (Grade1), and accepting up to one allele mismatch as per
Standard Practice Grade 2.1 for HLA-A, B, or C

- Donor must consent to granulocyte colony-stimulating factor (G-CSF) (filgrastim)
administration and leukapheresis

- Donor must have adequate veins for leukapheresis or agree to placement of central
venous catheter (femoral, subclavian)

Exclusion Criteria:

- Systemic anti-lymphoma therapy given in the previous 30 days

- Patients who have experienced progressive disease within 3 months of prior Bexxar or
Zevalin

- Inability to understand or give an informed consent

- Central nervous system lymphoma

- Pregnancy

- Fertile men or women unwilling to use contraceptive techniques during and for 12
months following treatment

- Southwest Oncology Group (SWOG)/Eastern Cooperative Oncology Group (ECOG) performance
score > 2

- Eligible for radioimmunotherapy-based autologous transplant trial

- Medical condition that would contraindicate allogeneic transplantation

- Evidence of Human Anti-Mouse Antibody (HAMA) for patients with prior exposure to
therapeutic murine antibodies

- Eligible for other therapeutic options that will be more likely to have a better
long-term disease-free survival with lower potential toxicity (e.g., non-transplant
therapy, autologous transplants, etc.) than this study

- Other grave medical conditions considered to represent contraindications to bone
marrow transplant (BMT) (e.g. unstable angina, pulmonary dysfunction [diffusing
capacity of the lung for carbon monoxide (DLCO) < 30%, total lung capacity (TLC) <
30%, continuous supplemental oxygen], acquired immune deficiency syndrome [AIDS],
etc.)

- DONOR: Identical twin

- DONOR: Age less than 12 years

- DONOR: Pregnancy

- DONOR: Infection with HIV

- DONOR: Inability to achieve adequate venous access

- DONOR: Known allergy to G-CSF

- DONOR: Current serious systemic illness or infection

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Treatment related mortality (TRM)

Outcome Time Frame:

At day +100

Safety Issue:

No

Principal Investigator

Ajay Gopal

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

1726.00

NCT ID:

NCT00119392

Start Date:

June 2004

Completion Date:

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • 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 Grade III Lymphomatoid Granulomatosis
  • 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
  • Splenic Marginal Zone Lymphoma
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Mantle-Cell

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109