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Phase I/II Study of the Combination of Bendamustine, Rituximab and Pixantrone in Patients With Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

Phase I/II Study of the Combination of Bendamustine, Rituximab and Pixantrone in Patients With Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma


Inclusion Criteria:



1. Part I: Subjects must have relapsed or refractory B cell NHL;

2. 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;

3. 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;

4. Age ≥ 18 years old;

5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2;

6. Subjects must have measurable or evaluable disease based on physical exam and/or
radiographs (CT, MRI, PET) or bone marrow involvement;

7. Female subject is either post-menopausal or surgically sterilized;

8. Laboratory Values:

- Absolute neutrophil count (ANC) ≥ 1.0 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

9. Ability to provide written informed consent obtained prior to participation in the
study and any related procedures being performed

Exclusion Criteria:

1. No chemotherapy, radiation, biologics or immunotherapy within 2 weeks prior to
registration (6 weeks if last received BCNU or mitomycin C).

2. No radioimmunotherapy within 2 months prior to registration.

3. 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.

4. 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.

5. 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.

6. Subjects who have received investigational drugs ≤ 4 weeks prior to registration.

7. 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 LVEF < 45%

- Any history of torsade de pointes, ventricular fibrillation, uncontrolled
ventricular tachycardia, or uncontrolled atrial fibrillation.

8. Female patients who are pregnant or breastfeeding

9. 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.

10. Concurrent use of other anti-cancer agents or anti-cancer treatments.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Anne Beaven, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

Pro00030834

NCT ID:

NCT01491841

Start Date:

November 2011

Completion Date:

November 2021

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Duke University Medical CenterDurham, North Carolina  27710