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Treatment Intensification With R-ICE and High-Dose Cyclophosphamide for Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

Treatment Intensification With R-ICE and High-Dose Cyclophosphamide for Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning


Patients will receive 3 cycles of chemotherapy prior to mid-treatment PET-CT.
Rituximab-CHOP, or an equivalent regimen must be used. During the third cycle of
Rituximab-CHOP chemotherapy, a PET-CT scan will be performed. The PET scan will be
designated as negative or positive. Based on the results, patients will either complete
standard dose therapy or receive two cycles of R-ICE followed by high dose cyclophosphamide
and rituximab.

A repeat PET-CT is required between 4 to 6 weeks following treatment completion. Patients
will be followed-up every 4 months for 2 years, then every 6 months for one year, then
annually until 5 years.


Inclusion Criteria:



- One of the following Biopsy-confirmed, aggressive non-Hodgkin's lymphoma

1. Diffuse large B-cell lymphoma

2. Mediastinal (thymic) B-cell lymphoma

- Any stage (I through IV) as defined by the Ann Arbor staging system

- ECOG performance status of 0 to 2

- Radiographically measurable disease

- No more than 3 cycles of chemotherapy for lymphoma

- Greater than or equal to 18 years

- Adequate pulmonary, cardiac, hepatic, or renal function

- HIV antibody negative

- Women- Not pregnant or breastfeeding

- Men of reproductive potential must agree to use contraception

Exclusion Criteria:

- Patients with the following aggressive lymphomas are not eligible:

1. Mantle cell

2. Lymphoblastic

3. Burkitt's

4. Mycosis fungoides/Sezary's syndrome

5. HTLV-1 associated T-cell leukemia/lymphoma

6. Primary CNS lymphoma

7. HIV-associated lymphoma

8. Transformed lymphomas

9. Immunodeficiency-associated lymphomas

- Previous diagnosis of another hematologic malignancies

- Progressive disease on CHOP or Rituximab-CHOP

- Active CNS involvement by lymphoma

- Serious co-morbid disease that could preclude full participation in study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate survival in patient receiving early treatment intensification based on a positive mid-treatment PET scan compared to the historical event-free survival of mid-treatment PET positive patients not given early treatment intensification.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Lode Swinnen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

J0802

NCT ID:

NCT00809341

Start Date:

January 2009

Completion Date:

September 2014

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • B-Cell
  • non-Hodgkin's
  • Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231