Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT01110135
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01110135
Study Brief:
Protocol Section:
NCT01110135