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

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center Genentech
Information provided by:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00809341

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.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: R-CHOP, R-CHOEP, R-EPOCH Drug: R-ICE, Cyclophosphamide	Phase II

MedlinePlus related topics: Lymphoma Nuclear Scans

Drug Information available for: Cyclophosphamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
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

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:

Estimate survival in patient receiving early treatment intensification based on a positive mid-treatment PET scan compared to the historical event-free survival of mid-treatment PET positive patients not given early treatment intensification. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Estimate overall survival in patients whose treatment is determined on the basis of a mid-treatment [18F] FDG-PET scan result. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	55
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PET Negative: Active Comparator PET Negative	Drug: R-CHOP, R-CHOEP, R-EPOCH Based on the PET-CT scan results patients will complete standard chemotherapy consisting of R-CHOP (or equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH)
PET Positive: Active Comparator PET Positive	Drug: R-ICE, Cyclophosphamide Two cycles of R-ICE, followed by high dose cyclophosphamide and Rituximab

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809341

Contacts

Contact: Lode Swinnen, MD

410-614-6398

lswinne1@jhmi.edu

Locations

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

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

Genentech

Investigators

Principal Investigator:

Lode Swinnen, MD

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Sidney Kimmel Comprehensive Cancer Center ( Lode Swinnen, MD )
Study ID Numbers:	J0802, NA_00013656
Study First Received:	December 16, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809341 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:

B-Cell
non-Hodgkin's
Lymphoma

Study placed in the following topic categories:

Immunoproliferative Disorders
Immunologic Factors
Rituximab
Cyclophosphamide
Immunosuppressive Agents
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases

B-cell Lymphomas
Antineoplastic Agents, Alkylating
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Antirheumatic Agents
Alkylating Agents
Lymphoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Immunosuppressive Agents
Pharmacologic Actions
Lymphoma, B-Cell

Lymphatic Diseases
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Alkylating Agents
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009