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Phase I Trial Of Intravenous Bispecific Antibody (4G7XH22) In Patients With Refractory Or Relapsed Non-Hodgkin's Lymphoma Or Chronic Lymphocytic Leukemia (CLL)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma

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Trial Information

Phase I Trial Of Intravenous Bispecific Antibody (4G7XH22) In Patients With Refractory Or Relapsed Non-Hodgkin's Lymphoma Or Chronic Lymphocytic Leukemia (CLL)


OBJECTIVES:

- Determine the maximum tolerated dose and dose-limiting toxicity of bispecific antibody
4G7xH22 in patients with relapsed or refractory non-Hodgkin's lymphoma or chronic
lymphocytic leukemia.

- Assess the clinical toxicity of this antibody in these patients.

OUTLINE: This is a dose escalation study of bispecific antibody (BsAb) 4G7xH22.

Patients receive sargramostim (GM-CSF) subcutaneously on day 1 and BsAb 4G7xH22 IV over 2
hours on day 2. Treatment repeats weekly for a total of 3 courses in the absence of
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6
patients experience dose-limiting toxicity.

Patients are followed weekly for 4 weeks, monthly for 3 months, and then periodically for 1
year.

PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of CD19+ non-Hodgkin's lymphoma or chronic lymphocytic leukemia

- Primary refractory or multiply relapsed (after at least 2 prior chemotherapy
regimens) disease

- Ineligible for bone marrow or peripheral blood stem cell transplantation

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-2

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC greater than 3,000/mm^3

- Platelet count greater than 100,000/mm^3

- Absolute neutrophil count greater than 1,500/mm^3

Hepatic:

- Bilirubin less than 1.5 mg/dL

- Alkaline phosphatase less than 2 times normal

- SGPT less than 2 times normal

Renal:

- Creatinine clearance greater than 50 mL/min

Other:

- No human-anti-murine-antibody response to prior murine monoclonal antibodies

- No immunological or inflammatory disease (e.g., lupus erythematosus)

- No active serious infection

- No other serious medical condition that would limit survival to less than 2 years

- No other active malignancy except non-melanoma skin cancer or carcinoma in situ of
the cervix

- No psychiatric or addictive disorder that would preclude study

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior immunotherapy allowed

Chemotherapy:

- See Disease Characteristics

- No concurrent chemotherapy

Endocrine therapy:

- Concurrent steroids for adrenal failure or adverse reactions to study drug allowed

- Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for
diabetes) allowed

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Pamela Ely, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068556

NCT ID:

NCT00014560

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • refractory chronic lymphocytic leukemia
  • 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 lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent small lymphocytic lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Norris Cotton Cancer CenterLebanon, New Hampshire  03756