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Study Summary
No. 2004-0818:.......Lymphoma......Felipe Samaniego......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:		2004-0818
Study Title: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
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Physician New Patient Referral
Name:Felipe SamaniegoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Pts will receive therapy in 21 day cycles. Pts will return for up to 9 cycles.
Follow-up after the end of txt consists of a visit 3 mos following the Off
Study visit and then every 3 mos for one year, every 6 mos for 2nd yr, then
once after 1 yr.
Treatment
Agents:		Cyclophosphamide
Pentostatin
Rituximab		Home Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of the clinical research study is to learn if treatment with a
combination of three drugs, Cytoxan (cyclophosphamide), Rituxan (rituximab) and
Nipent (pentostatin), will help to control the disease in patients with
previously untreated non-Hodgkin's lymphoma, CLL, or bulky lymphoma. The
safety of this treatment will also be studied.
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Study Objectives / Outcomes
Primary Objective:

      To determine the objective response rate, following treatment with pentostatin, rituximab, and cyclophosphamide, of patients with zero or one prior treatment regimen for stage III or IV, low-grade B-cell non-Hodgkin's lymphoma (NHL) or bulky lymphoma.

      Secondary Objectives:

      1. To determine the duration of response, time to progression, and time to
      treatment failure of patients with previously untreated or first line treated
      NHL

      2. To evaluate the toxicity of combination pentostatin, rituximab, and cyclophosphamide
      therapy

      3. To evaluate the incidence and severity of adverse events graded according
      to the NCI Common Terminology Criteria for Adverse Events (CTCAE)
      Version 3.0

      4. To correlate disease response of SLL/CLL with tumor ZAP70 expression
      and immunoglobulin heavy chain mutations.
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Study Status Information
Study Activation / Registration Date:06/29/2005
IRB Review and Approval Date:12/15/2004
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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 eligible

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 NHL.

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 Cockroft-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 registration.

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) illness.

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.
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Links
Registration Number: NCT00496873
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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