R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00809341
• Other study ID #: J0802
• Secondary ID: NA_00013656J0802
• Status: Terminated
• Phase: Phase 2
• Start date: January 2009
• Est. completion date: April 2014

Study information

• Verified date: September 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research is being done to see if a PET scan that is obtained after 3 cycles of a standard chemotherapy regimen can help guide treatment for patients with a blood disease called Non-Hodgkin's Lymphoma.

The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen can cure about half of patients with lymphoma, but in many others disease relapses (comes back). Relapses are generally treated with more chemotherapy.

We believe that a PET scan (a type of imaging study that "lights up" in areas of cells with high activity such as lymphoma), may identify patients early who are at high risk of relapse.

The purpose of this research study is to find out if people whose treatment is changed early to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have longer remissions than they would if they did not receive that high dose chemotherapy.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• Rituximab
375 mg/m^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m^2 on Days 1, 30, and 37 as part of HiCy.

Drug:
• Cyclophosphamide
750 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
• Doxorubicin
50 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
• Vincristine
1.4 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
• Prednisone
100 mg/day on Days 1-5 of each cycle as part of R-CHOP.
• Ifosfamide
2000 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.
• Carboplatin
Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.
• Etoposide
100 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.
• High-dose cyclophosphamide
50 mg/kg/day on Days 2-5 of HiCy.

Procedure:
• PET scan
Performed once between Days 16-20 of cycle 3 of R-CHOP.

Locations

Country	Name	City	State
United States	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan		2 years
Secondary	Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result.		5 years