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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00809341
First received: December 16, 2008
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PET Negative
PET negative patients will complete conventional therapy under a treatment plan formulated by their primary oncologist. Decisions regarding subsequent therapy, including BMT for disease relapse, will also be at the discretion of the primary oncologist.
 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)
Other Names:
  • R-CHOEP
  • R-EPOCH
  • R-CHOP
Active Comparator: PET Positive
R-ICE x 2 cycles (outpatient regimen; Pre-high dose therapy evaluations during R-ICE cycles; Cyclophosphamide 50mg/kg/day day2-5; rituximab d1, 30, 37
 Drug: R-ICE, Cyclophosphamide
Two cycles of R-ICE, followed by high dose cyclophosphamide and Rituximab
Other Names:
  • R-ICE
  • Hi CY
  • Rituxan

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.

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

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
ClinicalTrials.gov Identifier: NCT00809341     History of Changes
Other Study ID Numbers: J0802, NA_00013656, J0802
Study First Received: December 16, 2008
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
B-Cell
non-Hodgkin's
Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 16, 2013