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Phase II Randomized Trial of Early Versus Late Vaccination in Patients With High Risk CLL


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Phase II Randomized Trial of Early Versus Late Vaccination in Patients With High Risk CLL


OBJECTIVES:

- Determine the efficacy and toxicity of cyclophosphamide and rituximab in patients with
previously untreated, high-risk chronic lymphocytic leukemia.

- Determine, preliminarily, the efficacy and toxicity of early vs delayed administration
of vaccine therapy comprising KGEL and autologous tumor cells after cyclophosphamide
and rituximab in these patients.

- Compare the magnitude of the T-cell response to early vs delayed administration of this
vaccine after rituximab and cyclophosphamide and correlate these responses with the
extent of immune reconstruction.

OUTLINE: This is a randomized phase II study for patients with asymptomatic or minimally
symptomatic, untreated CLL with poor-risk features.

Patients undergo peripheral blood collection for vaccine production. Patients then receive
rituximab IV over at least 4 hours on days 1 and 2 in course 1 and on day 1 only in
subsequent courses and cyclophosphamide IV over 1 hour on day 1. Treatment with rituximab
and cyclophosphamide repeats every 21 days for up to 6 cycles in the absence of disease
progression. Patients undergo evaluation 4 weeks after completion of rituximab and
cyclophosphamide. Patients achieving partial or complete response are randomized to 1 of 2
vaccine treatment arms.

- Arm I (early administration): Beginning 2 weeks after evaluation, patients receive
vaccine therapy comprising an autologous tumor admixed with an allogeneic vaccine
(KGEL) that produces sargramostim (GM-CSF) and autologous tumor cells intradermally.
Treatment repeats every 3 weeks for 6 courses in the absence of unacceptable toxicity.

- Arm II (late administration): Beginning 20 weeks after evaluation, patients receive
vaccine therapy comprising KGEL and autologous tumor cells intradermally. Treatment
repeats every 3 weeks for 6 courses in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of chronic lymphocytic leukemia (CLL)

- Meets 1 of the following high-risk features:

- 17p deletion by fluorescent in situ hybridization (FISH)

- 11q deletion by FISH

- Unmutated immunoglobulin heavy chain variable region (IgVH) genes, defined as ≥
98% homology with germline in a Clinical Laboratory Improvement Act (CLIA)
approved laboratory

- Any stage disease

- Previously untreated disease

- Not requiring immediate treatment

- Absolute lymphocyte count ≥ 20,000/mm³

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Creatinine ≤ 2.0 mg/dL

- Bilirubin ≤ 2 mg/dL (unless secondary to obstructive cholestasis from lymphadenopathy
or Gilbert's disease)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infections requiring oral or intravenous antibiotics

- No autoimmune disorder (e.g., autoimmune hemolytic anemia) requiring corticosteroids
before the start of study vaccination

- No other malignancy except nonbasal cell skin cancer, carcinoma in situ of the
cervix, or tumor that was treated with curative intent ≥ 2 years ago

PRIOR CONCURRENT THERAPY:

- No prior therapy for CLL

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy and toxicity

Safety Issue:

Yes

Principal Investigator

Yvette L. Kasamon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

J0579 CDR0000481362

NCT ID:

NCT00343447

Start Date:

August 2006

Completion Date:

May 2007

Related Keywords:

  • Leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410