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

Johns Hopkins Medicine

Status and phase: Terminated; Phase 2

Conditions: Non-Hodgkin's Lymphoma

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00809341

NA_00013656 (Other Identifier)

J0802 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

PET Negative

Active Comparator group

Description:

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.

Treatment:

Biological: Rituximab

Procedure: PET scan

Drug: Doxorubicin

Drug: Prednisone

Drug: Vincristine

Drug: Cyclophosphamide

PET Positive

Active Comparator group

Description:

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).

Treatment:

Biological: Rituximab

Procedure: PET scan

Drug: Doxorubicin

Drug: Etoposide

Drug: Ifosfamide

Drug: Prednisone

Drug: High-dose cyclophosphamide

Drug: Vincristine

Drug: Cyclophosphamide

Drug: Carboplatin