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Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma Clinical research trials and Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma. Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma clinical trial. Test subjects typically obtain the finest healthcare available for their Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma  Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma
For Condition: Neutropenia,adult non-Hodgkin's lymphoma,adult diffuse large cell lymphoma,adult low grade non-Hodgkin's lymphoma
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Colony-stimulating factors such as pegfilgrastim may increase the number of immune system cells found in bone marrow or peripheral blood and may be effective in preventing or controlling neutropenia caused by chemotherapy. PURPOSE: Randomizedphase II trial to compare the effectiveness of two pegfilgrastim regimens in treating neutropenia after chemotherapy in patients who have mantle cell or diffuse large B-cell non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Compare the safety and efficacy, as measured by the duration of grade 4 neutropenia, of two different schedules of pegfilgrastim administered 4 hours vs 24 hours after cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP) in patients with stage III or IV or bulky stage II mantle cell or diffuse large B-cell non-Hodgkin's lymphoma . - Compare response rates in patients treated with these regimens. - Compare the number of patients who receive all planned doses of this chemotherapy regimen on time when treated with two different schedules of pegfilgrastim. - Compare the hematologic and nonhematologic toxic effects of these regimens in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to lymphoma type (mantle cell vs diffuse large B-cell). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive R-CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, vincristine IV, and rituximab IV on day 1 and oral prednisone on days 1-5. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 (within 4 hours after completion of R-CHOP) and placebo SC on day 2 (within 24 hours after completion of R-CHOP). - Arm II: Patients receive R-CHOP as in arm I. Patients also receive placebo SC on day 1 (within 4 hours after completion of R-CHOP) and pegfilgrastim SC on day 2 (within 24 hours after completion of R-CHOP). In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 16-90 patients (8-45 per treatment arm) will be accrued for this study within 6-20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histological confirmation of 1 of the following non-Hodgkin's lymphomas: - Mantle cell lymphoma - CD5 positive and CD23 negative - Diffuse large B-cell lymphoma, according to the REAL classification - International Prognostic Index score 0-2 - Measurable or evaluable disease - Ann Arbor stage III or IV or bulky stage II disease - No Burkitt's or B-lymphoblastic lymphoma - No premalignant myeloid conditions or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes or acute or chronic myelogenous leukemia) - No T-cell lymphoma or history of indolent lymphoma - No CNS involvement PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 75,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - AST and ALT less than 3 times upper limit of normal (ULN) - Bilirubin no greater than 1.5 times ULN Renal - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 50 mL/min Cardiovascular - No history of impaired cardiac status - No severe heart disease - No cardiomyopathy - No congestive heart failure - LVEF at least 50% at rest by MUGA or echocardiogram Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation - HIV negative - No active infection requiring treatment with systemic (IV or oral) anti-infectives (antibiotic, antifungal, or antiviral) within 72 hours of study therapy - No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No neurological contraindication to vincristine (e.g., peripheral neuropathy) - No known sensitivity to E. coli-derived drug products (e.g., filgrastim [G-CSF], Humulin® insulin, asparaginase, somatotropin, or interferon alfa) - No psychiatric, addictive, or other disorder that would preclude study compliance or giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - No prior bone marrow or stem cell transplantation - No prior pegfilgrastim - No other concurrent hematopoietic growth factors, except epoetin alfa for anemia - No concurrent WBC transfusions Chemotherapy - Not specified Endocrine therapy - No other concurrent corticosteroids, except any of the following: - Protocol-specific prednisone - Topical or inhaled steroids - Premedication for chemotherapy - Treatment for an adverse event Radiotherapy - No concurrent radiotherapy Surgery - More than 2 weeks since prior major surgery Other - No prior therapy for malignancy - At least 30 days since prior participation in an investigational device or drug study - No concurrent enrollment in another investigational device or drug study - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterRosen, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Peter Rosen 310-825-5268 ext. 41092
Additional Information:
Study ID Numbers: CDR0000319032; AMGEN-20020134,UCLA-0212095
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066833
Other Adult Diffuse Large Cell Lymphoma Studies:
1. Study of Allogeneic Bone Marrow Transplantation Using Matched, Related Donors in Patients With Nonmalignant Hematologic Disorders
2. Prophylaxis Trial of Posaconazole vs. Standard Azole Therapy for Neutropenic Patients
3. Gene Message (mRNA) Analysis of Granulocytes
4. Study of Unrelated Allogeneic Bone Marrow Transplantation in Patients With Benign Congenital Bone Marrow Failure Disorders
5. Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Related Studies:
Other adult diffuse large cell lymphoma Clinical Trials
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Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma
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