Clinical Trials Logo

Clinical Trial Summary

This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression, molecular response, and immunologic parameters related to this treatment.will have an ocular exam prior to treatment. Patients in this study will receive 6 cycles of combination chemotherapy with the standard CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for six to eight cycles. Patients achieving at least a partial response to chemotherapy will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be continued for 12 months in the absence of signs of progressive/recurrent disease, or unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on the presence of symptoms or other clinical manifestations of toxicity. Patients will undergo bone marrow evaluation for molecular testing at baseline. Those found to be positive will have repeat assessments performed post induction therapy, and after six months of PEG Intron. Patients will also undergo immunologic evaluation at baseline, post induction therapy, and after six months of PEG Intron. At the end of PEG Intron therapy, patients will have disease reevaluation and then annual data collection for long-term toxicity, duration of response and survival.


Clinical Trial Description

This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression, molecular response, and immunologic parameters related to this treatment. Adult patients with indolent, advanced stage, anthracycline naive NHL requiring treatment may be eligible. Patients must have measurable disease, no severe organ dysfunction, and normal ejection fraction in older patients. Patients also must have adequate hematologic, hepatic and renal function, performance status, and life expectancy of at least 18 months. Patients may not have CNS lymphoma, uncontrolled co-morbid conditions, pregnancy, HIV, and active psychiatric conditions. Additionally, patients may not have had prior hypersensitivity to interferon-alpha, other cancer within 5 years, significant heart disease or myocardial infarction within the last 6 months, and history of thrombosis. Additionally, patients will have an ocular exam prior to treatment. Patients in this study will receive 6 cycles of combination chemotherapy with the standard CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for six to eight cycles. Patients achieving at least a partial response to chemotherapy will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be continued for 12 months in the absence of signs of progressive/recurrent disease, or unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on the presence of symptoms or other clinical manifestations of toxicity. Patients will undergo bone marrow evaluation for molecular testing at baseline. Those found to be positive will have repeat assessments performed post induction therapy, and after six months of PEG Intron. Patients will also undergo immunologic evaluation at baseline, post induction therapy, and after six months of PEG Intron. At the end of PEG Intron therapy, patients will have disease reevaluation and then annual data collection for long-term toxicity, duration of response and survival. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00574730
Study type Interventional
Source University of Nebraska
Contact
Status Completed
Phase N/A
Start date May 23, 2001
Completion date June 7, 2012

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04240704 - Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL Phase 1
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Recruiting NCT00807196 - Zevalin With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Non Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT00764829 - Blood Samples to Evaluate Biomarkers of Donor Chimerism N/A
Completed NCT00726934 - The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients N/A
Completed NCT01517581 - Brown Fat Activity and White Fat Accumulation N/A
Completed NCT00193505 - Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma Phase 2
Terminated NCT01744912 - Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies Phase 1
Terminated NCT01500161 - Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match Phase 2
Active, not recruiting NCT03533283 - An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma Phase 1/Phase 2
Active, not recruiting NCT00001379 - Treatment and Natural History Study of Lymphomatoid Granulomatosis Phase 2
Completed NCT00901225 - Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant Phase 2
Terminated NCT01598025 - Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor N/A
Terminated NCT01326728 - Relapsed Malignant Blood Cancer After Allogeneic Hematopoietic Stem Cell Transplantation
Completed NCT01290549 - A Study of Escalating Doses of Polatuzumab Vedotin in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and Polatuzumab Vedotin in Combination With Rituximab in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma Phase 1
Completed NCT00807677 - A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies Phase 1
Completed NCT00837200 - Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies Phase 2
Terminated NCT00054834 - Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma Phase 1
Terminated NCT00003500 - Antineoplaston Therapy in Treating Patients With Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma Phase 2
Active, not recruiting NCT02099266 - Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment N/A