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Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed
Phase 1

Conditions

Lymphoma
Leukemia

Treatments

Biological: lumiliximab

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00058396
MSKCC-02096
IDEC-152-20
CDR0000288828 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Full description

OBJECTIVES:

  • Determine a recommended phase II dose of IDEC-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia.
  • Determine the safety profile of this drug in these patients.
  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
  • Determine the efficacy of this drug in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study.

Patients receive IDEC-152 monoclonal antibody IV over at least 2 hours on days 1, 2, 8, 15, and 22.

Cohorts of 3-10 patients receive escalating doses of IDEC-152 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3, 2 of 6, or 3 of 10 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 6 months.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed chronic lymphocytic leukemia OR small lymphocytic lymphoma

    • Stage III-IV OR

    • Stage I-II, if determined to have disease progression evidenced by 1 of the following characteristics:

      • Rapid doubling of peripheral lymphocyte count
      • Progressive lymphadenopathy
      • Progressive splenomegaly
      • B symptoms
      • Grade 2 or 3 fatigue
  • CD23+ disease

  • Progressive disease after at least 1 prior chemotherapy course

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • Platelet count at least 50,000/mm^3

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • AST/ALT no greater than 1.5 times upper limit of normal (ULN)

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • No New York Heart Association class III or IV cardiac disease
  • No myocardial infarction within the past 6 months
  • No unstable arrhythmia
  • No evidence of ischemia on EKG within the past 14 days

Pulmonary

  • FEV_1 at least 60% of predicted
  • DLCO at least 55% of predicted

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study treatment
  • HIV negative
  • No secondary malignancy requiring active treatment (except hormonal therapy)
  • No serious nonmalignant disease that would preclude study participation
  • No active uncontrolled bacterial, viral, or fungal infection
  • No clinically active autoimmune disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior anticancer biologic therapy
  • More than 4 weeks since prior anticancer radioimmunotherapy
  • No prior exposure to IDEC-152 or anti-CD23 antibodies

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior anticancer chemotherapy

Endocrine therapy

  • Concurrent hormonal therapy allowed for second malignancy

Radiotherapy

  • More than 4 weeks since prior anticancer radiotherapy

Surgery

  • More than 4 weeks since prior major surgery (except for diagnostic surgery)

Other

  • More than 4 weeks since prior anticancer investigational therapy
  • No other concurrent anticancer therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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