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A Phase II Study of Bendamustine (B), Etoposide (E), Dexamethasone (D), and GCSF for Peripheral Blood Hematopoietic Stem Cell Mobilization (BED)

Phase 2
18 Years
Open (Enrolling)
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Peripheral T-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Multiple Myeloma, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia

Thank you

Trial Information

A Phase II Study of Bendamustine (B), Etoposide (E), Dexamethasone (D), and GCSF for Peripheral Blood Hematopoietic Stem Cell Mobilization (BED)


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).


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).


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.

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)

- World Health Organization (WHO) classification of patients' malignancies must be

- 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

- 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)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Successful mobilization and collection of PBSCs

Outcome Description:

Defined as collection of > 2 x 10^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.

Outcome Time Frame:

Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride

Safety Issue:


Principal Investigator

Ajay Gopal

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Institutional Review Board

Study ID:




Start Date:

August 2010

Completion Date:

Related Keywords:

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Intraocular Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Multiple Myeloma
  • Small Intestine Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Hodgkin Disease
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Waldenstrom Macroglobulinemia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Mantle-Cell



Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109