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A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22+ B-Cell Lymphoma

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22+ B-Cell Lymphoma


- Determine the maximum tolerated dose and dose-limiting toxicity of monoclonal antibody
mono-dgA-RFB4 in patients with recurrent or refractory B-cell lymphoma expressing CD22

- Determine the pharmacokinetic profile of this drug in these patients.

- Correlate the pharmacokinetic parameters with the biologic effects and/or toxicity of
this drug in these patients.

- Determine whether clinical responses in these patients occur at lower, equal, or higher
doses than historical responses induced by a similar drug.

OUTLINE: This is a dose-escalation study. Patients are stratified according to number of
circulating tumor cells in peripheral blood (more than 50/mm3 vs 50/mm3 or less).

Patients receive monoclonal antibody Mono-dgA-RFB4 IV over 4 hours on days 1, 3, and 5.
Patients achieving complete, partial, or minimal remission receive additional courses of
therapy every 4 weeks in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody mono-dgA-RFB4 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of
3 or 2 of 6 patients experience dose-limiting toxicity.

Patients achieving complete remission or stable partial remission are followed every 3
months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-18

Inclusion Criteria


- Histologically confirmed recurrent or refractory B-cell lymphoma after at least 1
standard chemotherapy regimen

- Low, intermediate, or high grade

- CD22 antigen on at least 30% of tumor cells by flow cytometry

- No lymphoblastic lymphoma, B-cell chronic lymphocytic leukemia, B-cell or pre-B-cell
acute lymphocytic leukemia, or hairy cell leukemia

- Measurable disease

- Positive bone marrow not considered measurable

- Circulating tumor cells in peripheral blood considered measurable

- No CNS disease (leptomeningeal or parenchymal)

- No lymphomatous or infectious pulmonary parenchymal disease

- No baseline/pleural effusion

- Ineligible for or refused autologous or allogeneic bone marrow transplantation NOTE:
A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ.
The terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this
protocol uses the former terminology.



- Over 18

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months


- Platelet count greater than 50,000/mm^3

- Absolute granulocyte count greater than 750/mm^3


- Bilirubin less than 1.5 mg/dL

- SGPT less than 2 times upper limit of normal

- Albumin greater than 75% lower limit of normal


- Creatinine no greater than 1.4 mg/dL OR

- Creatinine clearance at least 60 mL/min


- Ejection fraction greater than 40% by MUGA or echocardiogram


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No human anti-mouse antibody (HAMA) levels greater than 1 microgram/mL

- No condition that may require stenting of ureters, stabilization of impending
pathological fractures, or relief of airway, bowel, or biliary tract obstruction

- No other concurrent illness that would preclude study


Biologic therapy:

- See Disease Characteristics


- See Disease Characteristics

- At least 2 weeks since prior chemotherapy and recovered

- No concurrent chemotherapy

Endocrine therapy:

- No concurrent corticosteroids unless receiving stable maintenance dose prior to


- No prior radiotherapy

- No concurrent radiotherapy


- Not specified


- No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Edward A. Sausville, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

November 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent small lymphocytic lymphoma
  • Lymphoma



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
Center for Cancer Research Bethesda, Maryland  20892