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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Ifosfamide
Carboplatin
Etoposide
High-dose cyclophosphamide
PET scan
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring B-Cell, non-Hodgkin's, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PET Negative

PET Positive

Arm 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.

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).

Outcomes

Primary Outcome Measures

Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan

Secondary Outcome Measures

Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result.

Full Information

First Posted
December 16, 2008
Last Updated
September 24, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00809341
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
B-Cell, non-Hodgkin's, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET Negative
Arm Type
Active Comparator
Arm 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.
Arm Title
PET Positive
Arm Type
Active Comparator
Arm 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).
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
750 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin, Hydroxydaunorubicin
Intervention Description
50 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Oncovin
Intervention Description
1.4 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
100 mg/day on Days 1-5 of each cycle as part of R-CHOP.
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Other Intervention Name(s)
Ifex
Intervention Description
2000 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VP-16
Intervention Description
100 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.
Intervention Type
Drug
Intervention Name(s)
High-dose cyclophosphamide
Other Intervention Name(s)
HiCy
Intervention Description
50 mg/kg/day on Days 2-5 of HiCy.
Intervention Type
Procedure
Intervention Name(s)
PET scan
Other Intervention Name(s)
FDG-PET
Intervention Description
Performed once between Days 16-20 of cycle 3 of R-CHOP.
Primary Outcome Measure Information:
Title
Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: One of the following Biopsy-confirmed, aggressive non-Hodgkin's lymphoma Diffuse large B-cell lymphoma 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: Mantle cell Lymphoblastic Burkitt's Mycosis fungoides/Sezary's syndrome HTLV-1 associated T-cell leukemia/lymphoma Primary CNS lymphoma HIV-associated lymphoma Transformed lymphomas 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lode Swinnen, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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