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Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [F] F.G.-PET Scanning

Phase 2
18 Years
70 Years
Open (Enrolling)

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Trial Information

Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [F] F.G.-PET Scanning



- Determine the 2-year progression-free survival (PFS) rate after treatment with
rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with bulky stage
II or stage III or IV diffuse large B-cell non-Hodgkin's lymphoma who remain positron
emission tomography (PET)-positive after 3 courses of rituximab, cyclophosphamide,
vincristine, doxorubicin hydrochloride, and prednisone.


- Determine the proportion of mid-treatment PET-positive patients who become PET-negative
after 4 courses of R-ICE.

- Determine the PFS of mid-treatment PET-negative patients treated with these regimens.

- Determine the overall survival of patients treated with these regimens.

- Determine the toxicity of these regimens in these patients.


- Rituximab and CHOP chemotherapy (R-CHOP): Patients receive rituximab IV,
cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and
oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 4 courses
in the absence of disease progression or unacceptable toxicity. Patients undergo
fludeoxyglucose F18 positron emission tomography (PET) scanning and conventional
restaging during course 3. Based on the PET results, patients are assigned to 1 of 2
treatment groups.

- Group I (PET negative): Patients receive 2 more courses of R-CHOP as above in the
absence of disease progression or unacceptable toxicity.

- Group II (PET positive): Patients receive R-ICE comprising rituximab IV on day 1,
ifosfamide IV continuously over 24 hours and carboplatin IV over 30 minutes on day
2, and etoposide IV over 2 hours on days 1-3. Patients also receive filgrastim
(G-CSF) subcutaneously once daily starting on day 4 and continuing until blood
counts recover. Treatment repeats every 14 days for 4 courses in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 10 years from
the date of study entry.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.

Inclusion Criteria


- Diffuse large B-cell non-Hodgkin's lymphoma

- Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease

- The following lymphoma types are excluded:

- Primary central nervous system lymphoma

- Transformed low-grade lymphoma (prior history of low-grade lymphoma or
clear presence of low-grade lymphoma on histologic sections)

- Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative
radiotherapy is usually indicated)

- Immunodeficiency-related lymphoma (i.e., after organ or bone marrow

- Measurable disease

- Patient must have at least one objective measurable disease site (i.e.,
measurable in at least 2 perpendicular parameters)

- Measurable disease in the liver is required if the liver is the only site of
lymphoma involvement

- Abnormal positron emission tomography scans will not constitute evaluable
disease, unless verified by CT scan or other appropriate imaging


- ECOG performance status 0-3

- For patients > 50 years of age, a normal ejection fraction by ECHO or MUGA is
required within 6 weeks prior to registration

- Absolute neutrophil count ≥ 1,500/mm^3*

- Platelet count > 100,000/mm^3*

- Creatinine < 2.0 mg/dL*

- Bilirubin < 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use an accepted and effective method of contraception

- No prior malignancy within the past 5 years unless it was in situ OR was treated with
curative intent AND the patient has remained relapse-free

- HIV negative NOTE: *Unless abnormal due to lymphoma


- No prior chemotherapy or radiation therapy for lymphoma

- No prior anthracyclines or platinum compounds used as systemic chemotherapy

- No prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow

- No concurrent pentostatin or trastuzumab (Herceptin®)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2- year progression-free survival (PFS)

Outcome Time Frame:

Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years.

Safety Issue:


Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



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