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

September 24, 2018 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Lode Swinnen, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 16, 2008

First Submitted That Met QC Criteria

December 16, 2008

First Posted (Estimate)

December 17, 2008

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J0802 (Other Identifier: SKCCCRO)
  • NA_00013656 (Other Identifier: JHMIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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