Evaluation of the Safety and Efficacy of Nipent, Cytoxan, and Rituxan

NCT00496873 | Completed Phase 2 Results

• 2 other identifiers: 2004-0818NCI-2010-00635
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999

  Number of participants with response out of total treated participants using IWG defined 6 categories based on IWG 1999 Response Criteria for NHL of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD). CR: is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. PR: is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions. SD: participants who have achieved less than a PR but who have not developed findings consistent with progressive disease.

  Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months

• Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu) With Low-grade Lymphoma (N=83) After 6-9 Cycles of PCR Therapy

  Number of participants with response according to the International Working Group (IWG) anatomic criteria for assessing six categories of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD), relapsed disease (RD), and progressive disease (PD). Response was assessed after 3, 6, and 9 cycles of therapy.

  9 cycles of 21 days, up to 7 months

Secondary Outcomes (1)

• 3-Year Progression-Free Survival

  PFS assessed 7 days prior to every cycle and then every 3 months after off-treatment for one year, every 6 months for second year, then once on third year

Study Arms (1)

Cytoxan + Rituxan + Nipent

EXPERIMENTAL

Cytoxan 600 mg/m\^2 on Day 1 of 21-day cycle. Rituxan 375 mg/m\^2 on Day 1 of 21 Day Cycle. Nipent 4 mg/m\^2 on Day 1 of 21 Day Cycle.

Drug: Cytoxan; Drug: Nipent; Drug: Rituxan

Interventions

Cytoxan DRUG

600 mg/m\^2 on Day 1 of 21-day cycle.

Also known as: Cyclophosphamide, Neosar

Cytoxan + Rituxan + Nipent

Nipent DRUG

4 mg/m\^2 on Day 1 of 21 Day Cycle.

Also known as: Pentostatin, Deoxycoformycin, DCF

Cytoxan + Rituxan + Nipent

Rituxan DRUG

375 mg/m\^2 on Day 1 of 21 Day Cycle.

Also known as: Rituximab

Cytoxan + Rituxan + Nipent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Bulky lymphoma or Stage II disease requiring chemotherapy will be considered for enrollment with documented Sponsor Investigator approval prior to registration.
• 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.
• Positive expression of cluster of differentiation antigen 20 (CD20) by biopsy or circulating lymphocytes.
• Zero or one prior chemotherapeutic or immunotherapeutic treatment regimen for B-cell NHL.
• Male or female greater than or equal to 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate renal function: Creatinine less than 1.5 mg/dL; blood urea nitrogen (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.
• Adequate bone marrow function: absolute neutrophil count (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.
• Adequate liver function: Bilirubin less than or equal to 2.0 mg/dL; AST and ALT less than or equal to 5 times upper limit of normal (ULN).
• Adequate cardiac function in the judgment of the Investigator, including New York Heart Association (NYHA) classification of I or II.
• Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration.
• 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.
• Completed Patient Informed Consent Form.

You may not qualify if:

• Previous or current intermediate or high-grade lymphoma.
• White blood cell count (WBC) greater than 30,000 cells/µL.
• 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.
• Known sensitivity to Nipent, Rituxan, Cytoxan or any component of these drugs.
• Patient received replacement steroid therapy less than 4 weeks prior to study registration.
• History of other malignancy that could affect the diagnosis or assessment of the study treatment.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) illness.
• Known prior history of and/or active viral hepatitis (HBV or HCV).
• Patient is unable to comply with the requirements of this study.
• Patients with Richter's transformation will be excluded.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Astex Pharmaceuticals, Inc.: collaborator
• Pharmatech: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Follicular

Interventions

Cyclophosphamide; Pentostatin; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Coformycin; Formycins; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Felipe Samaniego, MD/Associate Professor, Lymphoma/Myeloma
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Felipe Samaniego, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: June 1, 2005
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 29, 2023
• Results First Posted: August 23, 2016

Record last verified: 2023-03

Locations

US (1)