Expired Study
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Baltimore, Maryland 21231


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

J0802


NCT ID:

NCT00809341


Secondary ID:

NA_00013656


Study Acronym:


Brief Title:

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


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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Low accrual


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lode Swinnen, MD
Principal Investigator
Johns Hopkins University

Study Dates

Start Date:January 2009
Completion Date:April 2014
Completion Type:Actual
Primary Completion Date:April 2014
Primary Completion Type:Actual
Verification Date:September 2018
Last Changed Date:September 24, 2018
First Received Date:December 16, 2008
First Results Date:August 17, 2018

Study Outcomes

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

Study Interventions

Intervention Type:Biological
Name:Rituximab
Description: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.
Arm Name:PET Negative
Other Name:Rituxan
Intervention Type:Drug
Name:Cyclophosphamide
Description:750 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
Arm Name:PET Negative
Other Name:Cytoxan
Intervention Type:Drug
Name:Doxorubicin
Description:50 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
Arm Name:PET Negative
Other Name:Adriamycin
Intervention Type:Drug
Name:Vincristine
Description:1.4 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
Arm Name:PET Negative
Other Name:Oncovin
Intervention Type:Drug
Name:Prednisone
Description:100 mg/day on Days 1-5 of each cycle as part of R-CHOP.
Arm Name:PET Negative
Intervention Type:Drug
Name:Ifosfamide
Description:2000 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.
Arm Name:PET Positive
Other Name:Ifex
Intervention Type:Drug
Name:Carboplatin
Description:Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.
Arm Name:PET Positive
Other Name:Paraplatin
Intervention Type:Drug
Name:Etoposide
Description:100 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.
Arm Name:PET Positive
Other Name:VP-16
Intervention Type:Drug
Name:High-dose cyclophosphamide
Description:50 mg/kg/day on Days 2-5 of HiCy.
Arm Name:PET Positive
Other Name:HiCy
Intervention Type:Procedure
Name:PET scan
Description:Performed once between Days 16-20 of cycle 3 of R-CHOP.
Arm Name:PET Negative
Other Name:FDG-PET

Study Arms

Study Arm Type:Active Comparator
Arm Name:PET Positive
Description:R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a positive PET scan will receive two cycles of R-ICE (rituximab, ifosfamide, carboplatin, etoposide) followed by HiCy (high-dose cyclophosphamide).
Study Arm Type:Active Comparator
Arm Name:PET Negative
Description:R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a negative PET scan will complete their chemotherapy regimen as prescribed by their oncologist.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Genentech, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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