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A Single-Center, Open-Label Study to Evaluate the Safety and Efficacy of Nipent, Cytoxan, and Rituxan ("PCR") in the Treatment of Previously Untreated and Treated, Stage III or IV, Low-Grade B-Cell Non-Hodgkin's Lymphoma or Bulky Lymphoma

Phase 2
18 Years
Open (Enrolling)

Thank you

Trial Information

A Single-Center, Open-Label Study to Evaluate the Safety and Efficacy of Nipent, Cytoxan, and Rituxan ("PCR") in the Treatment of Previously Untreated and Treated, Stage III or IV, Low-Grade B-Cell Non-Hodgkin's Lymphoma or Bulky Lymphoma

All of the drugs [Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin)]
in this study are commonly used in the treatment of this cancer. However, using these drugs
in combination is investigational.

Before you can start treatment on this study, you will have what are called "screening
tests". These tests will help the doctor decide if you are eligible to take part in the
study. You will have a complete medical history and physical exam. You will have blood
collected (around 2-3 tablespoons) for routine tests. You will have a chest x-ray and CT
scans of the chest, abdomen (stomach), and pelvis (waist area). Tumors will be measured
using x-rays. You will have a sample of bone marrow collected. To collect a bone marrow
sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of
bone marrow is withdrawn through a large needle. If your doctor feels it is necessary, you
may also have lymph node biopsy samples taken for special tests. Women who are able to have
children must have a negative blood or urine pregnancy test.

During treatment you will be given a combination of three drugs in a 21 day (3 weeks) cycle.
All drugs will be given through a needle in a vein over 4-6 hours. You will receive
pentostatin first, then rituximab, and lastly cyclophosphamide. For each treatment cycle
cyclophosphamide, rituximab, and pentostatin will be given on Day 1, followed by 20 days of

During treatment, you will have around 2-3 tablespoons of blood collected at least once a
week for routine tests. You will also provide a urine sample for routine urine tests.
Depending on how the disease responds, treatment may be stopped after 3, 6, or 9 cycles.
You will be taken off treatment if your disease gets worse. If your treatment is delayed
for more than 2 weeks due to any side effect related to the treatment or for more than 3
weeks for any reason, you will be taken off of this study. If your doctor feels that you
are having serious or intolerable side effects that are not improved by standard supportive
care methods (such as medicine to control nausea or a transfusion to treat anemia) you will
be taken off of this study.

After Cycles 3, 6, and 9, tumors will be measured using x-rays or other scans (CT or MRI).
Bone marrow samples will be taken if they are needed to find out if the drug combination is
working to control your disease.

The maximum number of cycles that you can receive is 9. If you wish to continue using this
drug treatment, and it is beneficial to do so, you may continue to receive these drugs.
However, these drugs are commercially available, so you will be financially responsible
for the cost of these drugs.

After you receive the last cycle of chemotherapy, your doctor will decide your schedule of
follow-up exams. You will have follow-up exams every 3 months for one year, every 6 months
for 2nd year, then once after 1 year. During these exams, you will have a chest x-ray and CT
scans of the chest, abdomen (stomach), and pelvis (waist area). You will also have blood
collected (2-3 tablespoons) for routine tests.

This is an investigational study. All of the study drugs are approved by the FDA for cancer
treatment and are commercially available. However, the use of the drugs in combination is
investigational. Up to 100 patients will take part in this study. All enrolled will be at
M. D. Anderson.

Inclusion Criteria:

1. Histologically or cytologically proven, stage III or IV, low-grade B-cell NHL, as
defined by the updated WHO modification of the REAL classification for peripheral
B-cell neoplasms: B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma;
Lymphoplasmacytic lymphoma/immunocytoma; Follicular lymphoma; Extranodal marginal
zone B-cell lymphoma of MALT type; Nodal marginal zone B-cell lymphoma (+/-
monocytoid B-cells); Lymphoma with primarily bone marrow-only disease are considered

2. Bulky lymphoma or Stage II disease requiring chemotherapy will be considered for
enrollment with documented Sponsor Investigator approval prior to registration.

3. CT or MRI scans confirming measurable tumor size (lymph node must be >1cm in its
longest transverse diameter). Measurement by physical exam is acceptable in the case
of palpable and reproducibly measurable axillary or other superficial tumors.

4. Positive expression of CD20 by biopsy or circulating lymphocytes.

5. Zero or one prior chemotherapeutic or immunotherapeutic treatment regimen for B-cell

6. Male or female greater than or equal to 18 years of age.

7. ECOG performance status of 0-2.

8. Adequate renal function: Creatinine less than 1.5 mg/dL; BUN less than 30 mg/dL or a
creatinine clearance greater than or equal to 60 mL/min based on calculation of
creatinine clearance using the Cockcroft-Gault method or from a 24-hour urine
collection. Creatinine clearance 40- 59 mL/min from a 24-hour urine collection would
require a Nipent dose reduction of 25%. Patients with a Creatinine clearance <40
mL/min from a 24-hour urine collection will be excluded.

9. Adequate bone marrow function: ANC greater than or equal to 1,000 cells/µL; Platelet
count greater than or equal to 75,000 cells/µL; Hemoglobin greater than or equal to 9
g/dL. Patients with idiopathic thrombocytopenia or autoimmune hemolytic anemia are
eligible with prior approval of Sponsor Investigator.

10. Adequate liver function: Bilirubin less than or equal to 2.0 mg/dL; AST and ALT less
than or equal to 5 times ULN.

11. Adequate cardiac function in the judgment of the Investigator, including NYHA
classification of I or II.

12. Female patients of childbearing potential must have a negative serum pregnancy test
within 7 days prior to registration.

13. Patient agrees to use an acceptable method of birth control, if fertile patient (male
or female), to avoid pregnancy for the duration of the study and for at least 3
months thereafter.

14. Completed Patient Informed Consent Form.

Exclusion Criteria:

1. Previous or current intermediate or high-grade lymphoma.

2. WBC greater than 30,000 cells/µL.

3. Received prior therapy using Rituxan, unless such therapy was completed at least 6
months prior to study registration. Patients whose disease was non-responsive to
prior Rituxan therapy will be excluded.

4. Known sensitivity to Nipent, Rituxan, Cytoxan or any component of these drugs.

5. Patient received replacement steroid therapy less than 4 weeks prior to study

6. History of other malignancy that could affect the diagnosis or assessment of the
study treatment.

7. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)

8. Known prior history of and/or active viral hepatitis (HBV or HCV).

9. Patient is unable to comply with the requirements of this study.

10. Patients with Richter's transformation will be excluded.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Objective Response Rate (OR=CR+PR)

Outcome Time Frame:

Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days).

Safety Issue:


Principal Investigator

Felipe Samaniego, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • NHL
  • Lymphoma
  • B-cell chronic lymphocytic leukemia
  • SLL
  • Small Lymphocytic Lymphoma
  • Lymphoplasmacytic lymphoma/immunocytoma
  • Follicular lymphoma
  • Extranodal marginal zone B-cell lymphoma of MALT type
  • Nodal marginal zone B-cell lymphoma
  • Chronic Lymphocytic Leukemia
  • CLL
  • Bulky Lymphoma
  • Nipent
  • Cytoxan
  • Rituxan
  • Cyclophosphamide
  • Rituximab
  • Pentostatin
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



UT MD Anderson Cancer Center Houston, Texas  77030