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A Phase II, Open-Label, Randomized, Multicenter Trial To Evaluate The Preliminary Safety And Efficacy of Hu1D10 In Patients With Relapsed Or Refractory Grades I, II, or III B-Cell Non-Hodgkin's Lymphoma (Including Follicular, Small Lymphocytic And Marginal Zone/MALT)


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

Thank you

Trial Information

A Phase II, Open-Label, Randomized, Multicenter Trial To Evaluate The Preliminary Safety And Efficacy of Hu1D10 In Patients With Relapsed Or Refractory Grades I, II, or III B-Cell Non-Hodgkin's Lymphoma (Including Follicular, Small Lymphocytic And Marginal Zone/MALT)


OBJECTIVES:

- Compare the relative safety of 3 different regimens of monoclonal antibody Hu1D10 in
patients with relapsed or refractory grade I, II, or III B-cell non-Hodgkin's lymphoma.

- Compare the preliminary tumor response and progression-free survival of patients
treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3
treatment arms.

- Arm I: Patients receive monoclonal antibody (MOAB) Hu1D10 IV over approximately 2 hours
on days 1, 8, 15, and 22.

- Arm II: Patients receive MOAB Hu1D10 as in arm I at a higher dose.

- Arm III:Patients receive MOAB Hu1D10 IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24,
and 26.

Treatment in all arms continues in the absence of disease progression or unacceptable
toxicity.

Patients are followed at weeks 1, 4, and 12 and then at months 6, 9, 12, 18, and 24.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed relapsed or refractory grade I, II, or III non-Hodgkin's
lymphoma (NHL), including follicular, small lymphocytic, or marginal zone/MALT
lymphoma

- Previously treated with radiotherapy, immunotherapy, and/or chemotherapy for NHL

- Progression of disease or no response since last treatment for NHL

- 1D10+ lymphoma by immunohistochemistry or flow cytometry

- Bidimensionally measurable disease at least 2 cm in a single dimension

- No CNS metastases

- Circulating tumor cells no greater than 5,000/mm^3

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Platelet count at least 75,000/mm^3 (unless disease related)

- Neutrophil count at least 1,000/mm^3 (unless disease related)

- Hemoglobin greater than 8.0 g/dL

Hepatic:

- Bilirubin less than 2.5 mg/dL

- SGOT less than 4 times upper limit of normal

Renal:

- Creatinine less than 2.5 mg/dL

Cardiovascular:

- No clinically significant cardiac disease (New York Heart Association class III or
IV)

- No evidence of myocardial infarction or cardiac arrhythmia (unless surgically
repaired) within the past 6 months

Pulmonary:

- No clinically significant pulmonary disease

Other:

- No other malignancy within the past 2 years except non-melanoma skin cancer or
carcinoma in situ

- No significant psychiatric or CNS impairment

- No active serious infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after study

- Negative anti-Hu1D10 antibody response (HAHA/HAMA)

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- At least 4 weeks since prior interferon therapy

- At least 3 months since prior immunotherapy

- No prior monoclonal antibody Hu1D10

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior cytotoxic chemotherapy

Endocrine therapy:

- At least 4 weeks since prior corticosteroids (more than 10 mg prednisone/day)

- No concurrent corticosteroids at more than 10 mg prednisone/day for pre-existing
diseases or adverse reactions

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior external beam radiotherapy

- At least 3 months since prior radioimmunotherapy

Surgery:

- Not specified

Other:

- No other concurrent lymphoma therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Tillman Pearce, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Facet Biotech

Authority:

United States: Federal Government

Study ID:

CDR0000068585

NCT ID:

NCT00014664

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Protein Design Labs, Inc.Freemont, California  94555