Rituximab Plus CHOP With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00599170
First received: January 11, 2008
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The use of R-CHOP, given every two weeks, will be associated with improvements in response rate, and progression-free survival, when compared to R-CHOP given every three weeks. The addition of sargramostim will allow safer adminIstration of the dose-intensified R-CHOP, while at the same time, improving the functional capability of the macrophages, and thus increasing the likelihood of improved clinical response and disease-free survival.

The current phase II study is being proposed in order to develop preliminary data on the efficacy and toxicity of this approach, for future study in larger, phase III randomized trials. Laboratory correlates of response will also be studied, including activation markers on monocytes/macrophages before and after sargramostim exposure; and presence or absence of informative Fc gamma III polymorphisms.


Condition Intervention Phase
Diffuse, Large B-Cell, Lymphoma
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rituximab Plus CHOP Given Every Two Weeks With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • The primary endpoint in this trial will be tumor complete response (CR, CRu) to R-CHOP + GM-CSF, given every 14 days [ Time Frame: Every 2 cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response duration [ Time Frame: Every 2 cycles ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: January 2008
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Rituximab 375 mg/m2 iv on day 1 q 15 days just prior to CHOP, beginning with cycle 1.
Drug: Rituximab
375 mg/m2 IV

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously untreated, histologically or cytologically documented diffuse large B cell non-Hodgkin's lymphoma.
  2. Lymphoma must be CD20 positive.
  3. All stages of disease.
  4. Measurable or non-measurable tumor parameter(s). Non-measurable tumor parameters will be defined as not having bi-dimensional measurements (i.e. gastric or marrow involvement) but can be followed for response by other diagnostic tests such as gallium, PET imaging and/or bone marrow biopsy.
  5. Age ≥ 18 years.
  6. KPS ≥ 50% (ECOG PS 0, 1, or 2).
  7. Able to give signed informed consent.
  8. Adequate hepatic function: bilirubin ≤ 2.0 mg/dl (unless elevated secondary to lymphomatous involvement of liver or biliary system. For bilirubin > 3.0 due to hepatic involvement, the initial dose of doxorubicin will be decreased by 50%, and the initial dose of vincristine will be omitted. SGOT <5X upper limit of normal.
  9. Adequate renal function: creatinine < 2.0 mg/dl, or creatinine clearance ≥ 60 ml/min, unless secondary to renal involvement by lymphoma.
  10. Adequate hematologic function: granulocytes (ANC) >1000/mm3, platelets > 75,000/dl, unless these parameters are abnormal secondary to lymphomatous involvement of bone marrow. All patients must be off colony stimulating factor therapy at least 24 hours prior to institution of cycle #1 chemotherapy.
  11. Left ventricular ejection fraction that is at or above the lower institutional limits of normal, as assessed by nuclear scan or echocardiogram obtained within 6 weeks of registration.
  12. Concurrent radiation with or without steroids for emergency conditions secondary to lymphoma (i.e. CNS tumor, cord compression, etc) will be permitted, provided that additional, measurable or evaluable sites of lymphomatous disease are present at study entry.
  13. Female patients must have a negative pregnancy test within 72 hours of entering into the study. Both men and women will be included and, if of child bearing potential, must agree to use adequate contraception for the duration of the treatment. Women must avoid pregnancy and men avoid fathering children while in the study.

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Exclusion Criteria:

  1. Presence of second active tumor, other than non melanomatous skin cancer, carcinoma in situ of the cervix.
  2. Primary central nervous system lymphoma, including parenchymal brain or spinal cord lymphoma.
  3. Pregnant women or nursing mothers.
  4. ECOG performance score 3 or more (KPS <50%).
  5. Expected survival < 3 months.
  6. Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the principal investigator.
  7. Serious, on-going non-malignant disease or infection, which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
  8. Major surgery, other than diagnostic surgery, within four weeks.
  9. History of prior therapy with Rituximab within 12 months. Patients treated with Rituximab more than 12 months earlier are eligible only if it was given for indications other than the treatment of aggressive lymphoma.
  10. History of prior cytotoxic chemotherapy or radiotherapy for this lymphoma.
  11. History of cutaneous or muco-cutaneous reactions or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for 2 days or more. This exclusion relates to the long-term possibility of severe muco-cutaneous or cutaneous reactions to Rituximab, which maybe occurred at increased frequency in patients who have had severe skin disease or reactions in the past.
  12. Any acute inter-current infection that may interfere with planned protocol treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599170

Locations
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Anil Tulpule, MD University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00599170     History of Changes
Other Study ID Numbers: 13nhl-07-3
Study First Received: January 11, 2008
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
This is a standard phase II trial, in which patients with newly diagnosed diffuse large B cell lymphoma will receive R-CHOP with GM-CSF

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 31, 2014