Clinical trial NCT00809341: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: B-Cell
non-Hodgkin's
Lymphoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-12-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result.
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lode Swinnen, MD
role: PRINCIPAL_INVESTIGATOR
References: