Pilot Project for Creation of the Diffuse Large B-cell Lymphoma (DLBCL) Response Prediction Model

Study Visits:

If you are found to be eligible, you will have the following tests and procedures performed
during the 2 cycles of your already-scheduled chemotherapy.

Within 5 days before Cycle 1 of chemotherapy:

- You will have a physical exam.

- Blood (about 2 teaspoons) will be drawn for routine tests and to check the status of the
disease. You must fast (not eat or drink anything except water) for at least 6 hours
before this blood draw.

On Days 2 and 3 of Cycles 1 and 2 of chemotherapy, blood (about 2 teaspoons) will be drawn to
check the status of the disease. You should fast for at least 6 hours before the Day 3 blood
draw.

On Day 4 of Cycles 1 and 2 of chemotherapy:

- Blood (about 2 teaspoons) will be drawn to check the status of the disease. You must
fast for at least 6 hours before this blood draw.

- During Cycle 1 only, you will have an FDG-PET/CT scan to check the status of the
disease.

On Day 14 (+/- 5 days) of Cycles 1 and 2 of chemotherapy:

°Blood (about 2 teaspoons) will be drawn for routine tests and to check the status of the
disease. You must fast for at least 6 hours before this blood draw.

Within 5 days before the end of Cycle 2 of chemotherapy:

- You will have a physical exam.

- Blood (about 2 teaspoons) will be drawn for routine tests and to check the status of the
disease. You must fast for at least 6 hours before this blood draw.

- You will have an FDG-PET/CT scan to check the status of the disease.

Some of the blood collected on this study may be banked at the MD Anderson Lymphoma Tissue
Bank under MD Anderson Protocol 2005-0656. You will be given a separate consent form that
describes this banking.

Length of Study:

Your participation on this study will be over after the End-of-Study Visit.

End-of-Study Visit:

Within 21 days (+/- 5 days) after the start of Cycle 2 of chemotherapy, you will have an
FDG-PET/CT scan to check the status of the disease.

If the scan shows that the disease does not appear to be getting better, you will have a fine
needle aspiration (FNA), core needle biopsy, and/or an excisional biopsy to check the status
of the disease. To collect an FNA, a small amount of tissue is withdrawn through a needle. To
perform a core needle biopsy, a sample of tissue is removed using a hollow core needle that
has a cutting edge. To perform an excisional biopsy, the affected area is completely removed
by cutting it out.

Follow-Up:

Researchers may collect information from your medical record after your participation in this
study is over to check how you are doing.

This is an investigational study. FDG-PET/CT scans on this study are performed using
FDA-approved and commercially available methods.

Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Age 18 years or older at the time of screening.

2. Subject/legal representative willing and able to provide written informed consent.

3. Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL.

4. Willing to provide existing relapse-confirmatory DLBCL tumor sample.

5. Relapsed from or refractory to at least one treatment containing rituximab combined
with anthracycline-based chemotherapy.

6. CT scans showing involvement of 1 or more clearly demarcated lesions with a long axis
> 1.5 cm and short axis >/=1.0 cm.

7. Baseline FDG PET/CT scans must demonstrate at least one hypermetabolic lesion as
defined by the Deauville criteria (52) localizing to CT-defined anatomical tumor
sites.

8. Suitable candidate for therapy with high-dose chemotherapy and ASCT as determined by
the treating physician.

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

10. Life expectancy of >/=12 weeks as estimated by the treating physician.

11. Negative serum beta-human chorionic gonadotropin (Beta-hCG) test (women of
childbearing potential only).

12. Adequate organ function defined as follows: Serum creatinine calculated creatinine clearance (CrCl) >/= 50 mL/min as determined by the
Cockcroft-Gault equation.

Exclusion Criteria:

1. Any condition that, in the opinion of the investigator, would interfere with the
interpretation of study results or subject safety including non-malignant FDG avid
diseases such as sarcoidosis or other granulomatous disease.

2. Uncontrolled diabetes mellitus.

3. Concurrent enrollment in another clinical study where they are receiving non-standard
salvage chemotherapy, (i.e., concurrent enrollment is allowable if the patient is
receiving standard salvage chemotherapy and research imaging is allowed).

4. History of serious allergy or reaction to any component of RICE or RDHAP formulations
that would prevent administration.