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Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01110135
Recruitment Status : Completed
First Posted : April 26, 2010
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ajay Gopal, University of Washington

Study Description
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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

Condition or disease Intervention/treatment Phase
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 Drug: bendamustine hydrochloride Drug: dexamethasone Biological: filgrastim Procedure: leukapheresis Other: laboratory biomarker analysis Other: flow cytometry Drug: etoposide Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Bendamustine (B), Etoposide (E), Dexamethasone (D), and GCSF for Peripheral Blood Hematopoietic Stem Cell Mobilization (BED)
Study Start Date : August 2010
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Lymphosarcoma B-cell Lymphoma Diffuse Large B-Cell Lymphoma Multiple Myeloma Follicular Lymphoma Acute Lymphoblastic Leukemia Mantle Cell Lymphoma Lymphoblastic Lymphoma Peripheral T-cell Lymphoma Extranodal Nasal NK/T Cell Lymphoma Hodgkin Lymphoma Anaplastic Large Cell Lymphoma Chronic Lymphocytic Leukemia Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Cutaneous T-cell Lymphoma Burkitt Lymphoma Mycosis Fungoides Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Adult T-cell Leukemia/lymphoma Sezary Syndrome Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Leukemia, T-cell, Chronic Lymphomatoid Granulomatosis Chronic Graft Versus Host Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (chemotherapy and colony-stimulating factor)

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.

.

 Drug: bendamustine hydrochloride
Given IV
Other Names:
  • bendamustin hydrochloride
  • bendamustine
  • cytostasan hydrochloride
  • Treanda

Drug: dexamethasone
Given PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM

Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen

Procedure: leukapheresis
Given IV

Other: laboratory biomarker analysis
Correlative studies

Other: flow cytometry
Correlative studies

Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213


Outcome Measures
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Primary Outcome Measures :
  1. Successful Mobilization and Collection of PBSCs [ Time Frame: Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride ]
    Count of participants with successful mobilization and collection of PBSCs. 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%.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110135


Locations
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United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ajay Gopal Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
More Information
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Responsible Party: Ajay Gopal, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01110135    
Other Study ID Numbers: 7176
NCI-2010-00509 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 26, 2010    Key Record Dates
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Burkitt Lymphoma
Mycoses
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Hodgkin Disease
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Leukemia, Lymphocytic, Chronic, B-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
 Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Immunoblastic
Plasmablastic Lymphoma
Mycosis Fungoides
Sezary Syndrome
Leukemia, T-Cell
Lymphoma, T-Cell, Cutaneous
Waldenstrom Macroglobulinemia
Leukemia-Lymphoma, Adult T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphomatoid Granulomatosis
Lymphoma, Extranodal NK-T-Cell
Intraocular Lymphoma
Immunoblastic Lymphadenopathy
Recurrence