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SCCA Lymphoma Clinical Trials

Bendamustine + Dexamethasone + Filgrastim for Peripheral Stem Cell Mobilization (FH 7176)
A Phase II Study of Bendamustine (B), Dexamethasone (D), and GCSF (G) for Peripheral Blood Hematopoietic Stem Cell Mobilization
Status Conditions Phase Study ID
Closed Lymphoma
Multiple Myeloma
Phase II FH 7176
NCT01110135
Summary

RATIONALE: Giving chemotherapy, such as bendamustine hydrochloride and dexamethasone, before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be collected and stored.

PURPOSE: This phase II trial is studying how well giving bendamustine hydrochloride, dexamethasone, and filgrastim together for peripheral stem cell mobilization works in treating patients with refractory or recurrent lymphoma or multiple myeloma.


Investigator
Ajay K. Gopal, MD Damian J. Green, MD
Location    
SCCA Network 206-288-7232 Refer Patient
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

  • Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkin lymphoma), or multiple myeloma; other transplant eligible diagnoses (e.g. germ cell tumor) can be included with PI approval
  • WHO classification of patients' malignancies must be provided
  • Patients with multiple myeloma must have a serum protein electrophoresis with immunofixation; serum beta-2 microglobulin; serum free light chains; 24-hour urine collection for Bence-Jones protein (light chains) and monoclonal component by urine protein electrophoresis evaluated within one month of enrollment
  • Patients with lymphoid malignancies must have a CT of chest, abdomen, and pelvis within one month of enrollment; patients with evidence of lymphadenopathy in the neck must have a CT of neck
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient must have adequate:
  • Bone Marrow Function: ANC >= 1,500/mm^3
  • Platelets >= 100,000/mm^3 (without transfusion or growth factor support)
  • Renal Function: A creatinine clearance greater than 50/ml per minute by the following formula (all tests must be performed within 28 days prior to registration): CrCl = (140-age) (Wt in Kg) x 0.85 (female) OR 1.0 (male)/72 x serum Cr
  • Hepatic function:
  • Total bilirubin < 1.5 times upper limit of normal
  • AST and ALT < 2.5 times upper limit of normal
  • All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
  • Adequate venous access for apheresis procedure
  • Three or fewer prior myelotoxic treatment regimens

Exclusion

  • Patients known positive for HIV, or infectious hepatitis type B or C
  • Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • Patients who have previously demonstrated resistance to bendamustine therapy (i.e. no response or progression w/in 6 months)
  • Greater than four prior cycles of lenalidomide therapy
  • Fludarabine or other nucleoside analog (except gemcitabine or cytarabine) therapy within 24 months of registration
  • Symptomatic cardiopulmonary disease
  • Prior autologous or allogeneic transplantation
  • Prior radioimmunotherapy within 12 weeks of registration
  • Prior failed (< 5 x 10^6 CD34/kg) peripheral blood stem cell (PBSC) collection
  • Prior pelvic or spinal irradiation
  • Previous chemotherapy/immunotherapy within 3 weeks before study entry
  • Concurrent use of other anti-cancer agents or experimental treatments
  • Known allergy or intolerance to bendamustine, mannitol, GCSF or dexamethasone
  • More than 3 cycles of myelotoxic salvage chemotherapy within the past 4 months (specific regimens include ICE, DHAP, MTX/HiDAC, hyperCVAD, VTD-PACE)
Last Updated
September 10, 2014
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.