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

NCT00809341 | Terminated Phase 2 Results DMC

• 2 other identifiers: J0802NA_00013656
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Hodgkin's Lymphoma

Keywords

B-Cell; non-Hodgkin's; Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (1)

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

  5 years

Study Arms (2)

PET Negative

ACTIVE COMPARATOR

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; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Procedure: PET scan

PET Positive

ACTIVE COMPARATOR

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; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide; Drug: High-dose cyclophosphamide; Procedure: PET scan

Interventions

Rituximab BIOLOGICAL

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.

Also known as: Rituxan

PET Negative; PET Positive

Cyclophosphamide DRUG

750 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.

Also known as: Cytoxan

PET Negative; PET Positive

Doxorubicin DRUG

50 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.

Also known as: Adriamycin, Hydroxydaunorubicin

PET Negative; PET Positive

Vincristine DRUG

1.4 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.

Also known as: Oncovin

PET Negative; PET Positive

Prednisone DRUG

100 mg/day on Days 1-5 of each cycle as part of R-CHOP.

PET Negative; PET Positive

Ifosfamide DRUG

2000 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.

Also known as: Ifex

PET Positive

Carboplatin DRUG

Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.

Also known as: Paraplatin

PET Positive

Etoposide DRUG

100 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.

Also known as: VP-16

PET Positive

High-dose cyclophosphamide DRUG

50 mg/kg/day on Days 2-5 of HiCy.

Also known as: HiCy

PET Positive

PET scan PROCEDURE

Performed once between Days 16-20 of cycle 3 of R-CHOP.

Also known as: FDG-PET

PET Negative; PET Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Ifosfamide; Carboplatin; Etoposide; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Lode Swinnen
• Organization: Johns Hopkins Sidney Kimmel Cancer Center

lswinne1@jhmi.edu

410-955-8603

Study Officials

• Lode Swinnen, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: January 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 25, 2018
• Results First Posted: September 25, 2018

Record last verified: 2018-09

Locations

US (1)