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SCCA Lymphoma Clinical Trials

Combination Chemotherapy + G-CSF + Plerixafor for Lymphoma Patients Undergoing Mobilization of Autologous PBSC (FH 2310)
Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor
Status Conditions Phase Study ID
Recruiting Non-Hodgkin's Lymphoma Phase II FH 2310
NCT01097057
Summary

RATIONALE: Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as filgrastim (G-CSF), and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.

PURPOSE: This phase II trial is studying how well giving rituximab, ICE combination chemotherapy, and G-CSF together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells.


Investigator
Leona Holmberg, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Hepatic: bilirubin =< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome) and ALT and AST =< 3 times the upper limit of normal
  • Cardiac: left ventricular ejection fraction at rest >= 50% demonstrated by MUGA or echocardiogram
  • Renal: creatinine clearance (calculated creatinine clearance is permitted) > 50 mL/min
  • Signed informed consent
  • Planned autologous transplant within 3 months after collection of PBSCs
  • Diagnosis of CD20+ non-Hodgkin's lymphoma

Exclusion

  • HIV positive
  • Karnofsky performance score < 70%
  • Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
  • Pregnant or breastfeeding
  • Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization
  • Prior autologous or allogeneic HSCT
  • Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
  • Hepatitis B carriers
  • Prior other malignancies except resected basal cell carcinoma or treated cervical carcinoma or breast cancer in situ; cancer treated with curative intent > 5 years previously will be allowed
  • Other investigational agents during study participation
Last Updated
November 07, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.