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Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, B-Cell

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Trial Information

Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma


This is a phase II efficacy trial for patients with untreated, high-risk, B-cell
Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose
chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in
previously untreated patients with high-risk NHL


Inclusion Criteria:



- Untreated, biopsy proven B-cell non-Hodgkin's lymphoma

- Age >/= 18 years

- No other prior malignancy except for adequately treated basal cell or squamous cell
skin cancer, in situ cervical cancer, or other cancer for which the patient has been
disease-free for one year. The patient cannot have been exposed to chemotherapy to
treat any of these diseases for at least 3 years prior to study entry.

- Meet staging studies and laboratory tests prior to induction, consolidation and
radioimmunotherapy.

Exclusion Criteria:

- Significant medical and/or psychiatric illness which may compromise planned
treatment;

- Pregnant or lactating;

- HIV-infection.

- Patients with follicular lymphoma grade 1, 2 or 3A are not eligible for this trial.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

1 Year Progression-free Survival Rate

Outcome Description:

Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

David Rizzieri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke Unversity Medical Center

Authority:

United States: Institutional Review Board

Study ID:

Pro00007096

NCT ID:

NCT00577629

Start Date:

June 2005

Completion Date:

February 2021

Related Keywords:

  • Lymphoma, B-Cell
  • high risk non-hodgkins lymphoma
  • NHL
  • Bexxar
  • high dose chemotherapy
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Duke University Medical CenterDurham, North Carolina  27710