Brief Title
Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma
Official Title
A Phase II Study of Bendamustine (B), Etoposide (E), Dexamethasone (D), and GCSF for Peripheral Blood Hematopoietic Stem Cell Mobilization (BED)
Brief Summary
This phase II trial is studying how well giving bendamustine hydrochloride, etoposide,
dexamethasone, and filgrastim together for peripheral stem cell mobilization works in
treating patients with refractory or recurrent lymphoma or multiple myeloma. Giving
chemotherapy, such as bendamustine hydrochloride, etoposide, 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 filgrastim, and certain
chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be
collected and stored
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the frequency of bendamustine (bendamustine hydrochloride) combined with GCSF
(filgrastim) and dexamethasone to successfully mobilize peripheral blood stem cells (PBSCs)
(as determined by collecting a minimum of 2 x 10^6 cluster of differentiation (CD)34+/kg).
SECONDARY OBJECTIVES:
I. To evaluate the response rate to bendamustine by diagnosis using established
disease-specific response criteria.
II. To examine the number of apheresis cycles required to collect a minimum of 2 x 10^6 CD34+
cells/kg and ideally >= 5 x 10^6 CD34+ cells/kg (when achievable).
III. To assess the impact of bendamustine on B and T-lymphocyte populations in the peripheral
blood (CD20+ cells, natural killer [NK] cells, CD4+25+ foxP3- regulatory cells, and CD8
cells).
OUTLINE:
Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 1
and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone orally (PO) on days 1-4,
and filgrastim subcutaneously (SC) beginning on day 5 and continuing until peripheral blood
stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3
days or until > 5 x 10^6 CD34+/kg has been collected.
After completion of study treatment, patients are followed for up to 5 years.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Successful Mobilization and Collection of PBSCs
Condition
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Intervention
bendamustine hydrochloride
Study Arms / Comparison Groups
Treatment (chemotherapy and colony-stimulating factor)
Description: Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected. .
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
43
Start Date
August 2010
Primary Completion Date
November 2013
Eligibility Criteria
Inclusion Criteria:
- 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 principal investigator (PI)
approval
- World Health Organization (WHO) classification of patients' malignancies must be
provided
- Patients with lymphoid malignancies must have a computed tomography (CT) of chest,
abdomen, and pelvis within six weeks 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
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelets >= 100,000/mm^3 (without transfusion or growth factor support)
- Creatinine clearance (CrCl) greater than 50/ml per minute (all tests must be performed
within 28 days prior to registration)
- Total bilirubin < 1.5 times upper limit of normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (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 plan in place for apheresis procedure
- Three or fewer prior myelotoxic treatment regimens (specific regimens include
ifosfamide, carboplatin and etoposide [ICE]; cisplatin, cytarabine, and dexamethasone
[DHAP]; methotrexate [MTX]/high-dose cytarabine [HiDAC]; cyclophosphamide,
vincristine, doxorubicin, and dexamethasone [hyperCVAD]; bortezomib, thalidomide,
dexamethasone and 4-day continuous infusions of cisplatin, doxorubicin,
cyclophosphamide, and etoposide [VTD-PACE])
Exclusion Criteria:
- Patients known positive for human immunodeficiency virus (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
- Greater than six prior cycles of lenalidomide therapy
- Patients who have previously demonstrated resistance to bendamustine therapy (i.e. no
response or progression w/in 6 months)
- Fludarabine or other nucleoside analog (except gemcitabine or cytarabine) therapy
within 24 months of registration; patients with limited exposure to fludarabine/other
nucleoside analog therapy within 24 months may be considered eligible with review and
approval by the PI or Co-PI prior to study entry
- Symptomatic cardiopulmonary disease
- Prior autologous or allogeneic transplantation
- Prior radioimmunotherapy within 12 weeks of registration
- Prior failed (< 5 x 10^6 CD34/kg) PBSC collection due to inability to mobilize stem
cells
- Prior pelvic or spinal irradiation
- Previous systemic 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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ajay Gopal, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01110135
Organization ID
7176
Secondary IDs
NCI-2010-00509
Responsible Party
Principal Investigator
Study Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Ajay Gopal, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Verification Date
April 2017