Status:
COMPLETED
IIT CTI Bendamustine, Rituximab, Pixantrone in Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Anne Beaven, MD
Collaborating Sponsors:
CTI BioPharma
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase I trial of the combination of bendamustine, rituximab and pixantrone in patients with relapsed/refractory B cell non-Hodgkin lymphoma. A standard 3+3 design will be used to determine t...
Detailed Description
This is a phase I trial utilizing a traditional 3+3 design to evaluate maximum tolerated dose (MTD) and optimal dose schedule of pixantrone in combination with bendamustine (120mg/m2 on day 1 of each ...
Eligibility Criteria
Inclusion
- Part I: Subjects must have relapsed or refractory B cell NHL;
- Part II: Subjects must have relapsed or refractory aggressive B cell NHL including follicular lymphoma (FL) grade 3, Diffuse Large B Cell Lymphoma (DLBCL), transformed NHL, mantle cell lymphoma (MCL), or other aggressive B cell NHL histology as per the WHO 2008 criteria;
- Refractory disease (defined as persistence of evaluable disease after therapy) or relapsed disease following at least one prior treatment regimen that should include autologous stem cell transplant unless a patient was not eligible or refused prior transplant;
- Age ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2;
- Subjects must have measurable or evaluable disease based on physical exam and/or radiographs (CT, MRI, PET) or bone marrow involvement;
- Female subject is either post-menopausal or surgically sterilized;
- Laboratory Values:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; lower levels accepted if due to marrow involvement by lymphoma
- Platelets ≥ 75,000/mcl; lower levels accepted if due to marrow involvement by lymphoma
- Total bilirubin ≤ 1.5 X institutional upper limit of normal; ≤ 3.0 ULN accepted in subjects with Gilbert's Syndrome
- AST/ALT ≤ 1.5 X institutional upper limit of normal. Subjects with known liver involvement by lymphoma: AST/ALT ≤ 2 X institutional upper limit of normal
- Serum creatinine \< 1.5 X institutional upper limit of normal
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
Exclusion
- No chemotherapy, radiation, biologics or immunotherapy within 2 weeks prior to registration (6 weeks if last received BCNU or mitomycin C).
- No radioimmunotherapy within 2 months prior to registration.
- Subjects receiving chronic, systemic treatment with corticosteroids equivalent to \> 20mg of prednisone per day. Subjects receiving replacement for adrenal insufficiency will be allowed on the study. Topical or inhaled corticosteroids are allowed.
- Subjects with a history of another primary malignancy ≤ 3 years ago, with the exception of inactive basal, squamous cell carcinoma of the skin or superficial melanoma only requiring excision, prostate cancer with a PSA that has not increased for at least 3 months, carcinoma in situ of the cervix.
- Major surgery ≤ 4 weeks prior to registration. Minor surgery ≤ 2 weeks prior to registration. Insertion of a vascular access device is not considered major or minor surgery. Subjects must have recovered from all surgery related toxicities to ≤ grade 1 or to baseline if subject started with \> grade 1 toxicity, not otherwise violating the above inclusion criteria.
- Subjects who have received investigational drugs ≤ 4 weeks prior to registration.
- Impaired Cardiac Function:
- QTc \> 480 on screening ECG.
- Previous history of angina pectoris or acute MI within 6 months
- Congestive heart failure (New York Heart Association functional classification III-IV) or baseline MUGA/ECHO shows estimated LVEF \< 45%
- Any history of torsade de pointes, ventricular fibrillation, uncontrolled ventricular tachycardia, or uncontrolled atrial fibrillation.
- Female patients who are pregnant or breastfeeding
- Patients with history of untreated hepatitis B or who are known carriers of hepatitis B will be excluded from this trial. All subjects will be screened prior to study entry.
- Concurrent use of other anti-cancer agents or anti-cancer treatments.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01491841
Start Date
November 1 2011
End Date
February 17 2017
Last Update
March 4 2020
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705