IIT CTI Bendamustine, Rituximab, Pixantrone in Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma

Completed · Phase 1

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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 the maximum tolerated dose (MTD) of the combination. A static dose of bendamustine and rituximab will be used and the dose of pixantrone will be escalated in each cohort. Pixantrone will be dosed on a 21 day cycle at 55mg/m2, 85mg/m2, and 115mg/m2 in sequential cohorts dependent on acceptable toxicity profile at each dose level. MTD will be determined based on DLTs that occur during the first 2 cycles of the drug combination. Phase II did not proceed as planned due to withdrawal of pixantrone from the US.

Key facts

Study ID

NCT01491841

Run by

Anne Beaven, MD

People needed

33

Starts

2011-11-01

Expected to finish

2017-02-17

Last updated by the study team

2020-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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