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Phase III, Double-Blind, Randomized, Placebo-Controlled Trial of FavID® (Id/KLH) and GM-CSF Following CHOP/Rituximab as First-Line Therapy in Subjects With High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase III, Double-Blind, Randomized, Placebo-Controlled Trial of FavID® (Id/KLH) and GM-CSF Following CHOP/Rituximab as First-Line Therapy in Subjects With High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma


OBJECTIVES:

Primary

- Compare the 3-year disease-free survival of patients with high-intermediate- or
high-risk bulky stage II or stage III or IV diffuse large B-cell lymphoma treated with
sargramostim (GM-CSF) with or without autologous immunoglobulin idiotype-KLH conjugate
vaccine (FavId®) after combination chemotherapy comprising cyclophosphamide,
doxorubicin, vincristine, prednisone, and rituximab (CHOP-R).

Secondary

- Compare the 2-year disease-free survival, duration of response, time to progression,
overall survival, and safety in patients treated with these regimens.

- Estimate the rate of immune reactivity to FavId®.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to risk score (3 [high-intermediate] vs 4 or 5 [high]).

- Chemotherapy: Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV,
vincristine IV, and rituximab IV on day 1 and oral prednisone on days 1-5. Treatment
repeats every 21 days for up to 8 courses in the absence of disease progression or
unacceptable toxicity.

- Sargramostim (GM-CSF) with or without autologous immunoglobulin idiotype-KLH conjugate
vaccine (FavId®): Patients achieving complete remission (CR) or unconfirmed CR after
chemotherapy and who have FavId® available are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive FavId® vaccine subcutaneously (SC) on day 1. Patients also
receive sargramostim (GM-CSF) SC on days 1-4.

- Arm II: Patients receive placebo SC on day 1 and GM-CSF SC as in arm I. In both
arms, treatment repeats once a month for 6 months and then once every 2 months for
24 months (18 total vaccinations) in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 480 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diffuse large B-cell lymphoma

- Bulky stage II or stage III or IV disease

- Treatment naïve

- International Prognostic Index score of 3 (high-intermediate) or 4/5 (high)

- Lymphoma accessible for sampling or existing biopsy material judged suitable for
preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId®)

- No history of CNS lymphoma or meningeal lymphomatosis

- No history of indolent lymphoma

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Platelet count > 75,000/mm^3

- ALT and AST < 2 times upper limit of normal

- Not pregnant or nursing

- No history of unresolved hepatitis B viral infection

- No history of a treated prior malignancy unless in remission ≥ 2 years, except for
treated nonmelanoma carcinomas of the skin or in situ cervical carcinomas or
prostatic carcinomas

- No contraindication to doxorubicin hydrochloride (e.g., abnormal contractility on
ECG)

- No contraindication to vincristine (e.g., peripheral neuropathy)

- No know HIV positivity

- No serious nonmalignant disease, including any of the following:

- Psychiatric disorders

- Compromised pulmonary function

- Congestive heart failure

- Active bacterial, viral, or fungal infections

PRIOR CONCURRENT THERAPY:

- No prior keyhole limpet hemocyanin

- No planned radiotherapy during or after study therapy

- No concurrent systemic immunosuppressive therapy (e.g., steroids)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival as measured by the Kaplan-Meier method at 3 years

Principal Investigator

John F. Bender, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

Favrille

Authority:

United States: Federal Government

Study ID:

CDR0000466677

NCT ID:

NCT00324831

Start Date:

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Tower Cancer Research FoundationBeverly Hills, California  90211