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CompletedNCT00002681Updated Jun 10, 2011

Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma

A Phase 1/2 interventional study of aldesleukin and daclizumab in Leukemia and Lymphoma, sponsored by Roger Williams Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-10.

Sponsored by Roger Williams Medical Center · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia or lymphoma cells. Combining these two therapies may be an effective treatment for leukemia and lymphoma.

PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy plus interleukin-2 in treating patients who have leukemia or lymphoma.

Read the detailed description

OBJECTIVES:

  • Assess the safety and tolerability of a multidose regimen of humanized anti-Tac monoclonal antibody (HAT) and interleukin-2 (IL-2) in patients with leukemia and lymphoma.
  • Describe the pharmacokinetics/pharmacodynamics of HAT and IL-2 in a multidose schedule, including serum half-life of free HAT, area under the curve, and volume of distribution.
  • Evaluate the immunogenicity of HAT.
  • Identify immunologic parameters that correlate with efficacy.
  • Evaluate the preliminary efficacy of HAT in these patients.
  • Monitor patients receiving indium-111-labeled HAT for circulating infused antibody for pharmacokinetics, tumor imaging, and bioactivity (binding ability).

OUTLINE: Patients are stratified according to disease (Hodgkin's lymphoma vs acute myelogenous leukemia vs chronic myelogenous leukemia).

Patients receive humanized anti-TAC monoclonal antibody (HAT) IV over 30 minutes on day 1, then IV over 30 minutes every 7 days and interleukin-2 subcutaneously daily. Treatment continues for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of neutralizing antibodies.

Patients are followed weekly for 2 months.

PROJECTED ACCRUAL: A total of 25 patients with Hodgkin's lymphoma and 14 each with AML and CML will be accrued for this study.

02

Conditions studied

  • Leukemia
  • Lymphoma

Keywords

  • recurrent adult Hodgkin lymphoma
  • recurrent adult acute myeloid leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • atypical chronic myeloid leukemia, BCR-ABL negative
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 25 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Roger Williams Medical Center is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of one of the following malignancies:

    • Hodgkin's lymphoma
    • Acute myelogenous leukemia
    • Chronic myelogenous leukemia
  • Failed standard therapy or in chronic phase if on standard therapy
  • At least 30% of malignant cells reactive with anti-Tac as determined by immunofluorescence studies

    • All Hodgkin's lymphoma patients eligible due to 100% Tac-positivity of Reed-Sternberg cells
  • Measurable disease
  • No symptomatic CNS disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • 0-2

Life expectancy:

  • Greater than 2 months

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 3 times normal
  • No significant hepatic disease

Renal:

  • Creatinine no greater than 3 times normal
  • No significant renal disease

Cardiovascular:

  • No significant cardiovascular disease

Pulmonary:

  • No significant pulmonary disease

Other:

  • No significant endocrine, rheumatologic, or allergic disease
  • No HIV-I antibody
  • No active disease due to any of the following:
  • Cytomegalovirus Herpes simplex virus I/II
  • Hepatitis B or C Tuberculosis
  • Negative pregnancy test required of fertile women

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior murine anti-Tac monoclonal antibody

Chemotherapy:

  • At least 4 weeks since chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since radiotherapy

Surgery:

  • Not specified

Other:

  • Concurrent treatment allowed for complications of primary disease
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Enrollment
25 participants (estimated)

Interventions

  • Biologicalaldesleukin
  • Biologicaldaclizumab
06

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002681
Lead sponsor
Roger Williams Medical Center
Collaborators
National Cancer Institute (NCI), Beth Israel Deaconess Medical Center
First posted
Jan 27, 2003
Start date
Jul 1995
Primary completion
Sep 2003
Completion
Dec 2003
Last update
Jun 10, 2011

Study contacts

Richard P. Junghans, MD, PhD
study chair · Beth Israel Deaconess Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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