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Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant

Phase 2
18 Years
Open (Enrolling)
Mantle Cell Lymphoma

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Trial Information

Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant

Inclusion Criteria:

- Untreated, non-transplant eligible, newly diagnosed mantle cell lymphoma with
measurable disease as determined by CT, and bone marrow biopsy.

- Age > or = to 65 years or > 18 year and ineligible for HDT/ASCT.

- Subjects must not be candidates for intensive high-dose chemotherapy, with or without
an autologous stem cell transplant (ASCT), due to one or more of the following

- Age ≥ 65 years

- Patients <65 years of age must be ineligible for HDT/ASCT on the basis of
comorbidity, organ dysfunction or patient refusal for HDT/ASCT Comorbid disease, such
as CAD, CHF, pulmonary dysfunction, liver or kidney dysfunction, precluding high dose
therapy secondary to expected increased morbidity and mortality.

- poor performance status (KPS 70% or less)

- Ejection fraction <45%

- Impaired pulmonary function test with DLCO <50% expected

- Patient refusal

- Medical conditions which in the opinion of the treating physician and DMT preclude

- Patients must have a serum creatinine clearance ≥ 40 mL/min (as per the Jelliffe
method) or by 12-hour or 24-hour urine creatinine clearance.

- Patients must have ANC>1,000/mcl and Platelets>100,000/mcl (unless secondary to MCL).

- Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of
Gilbert's disease (or pattern consistent with Gilbert's).

- Negative serologies for Hepatitis B (HB) defined as a negative test for HBsAg. In
addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB
DNA test will be performed and if negative, patient may be included but must undergo
HBV DNA PCR testing at the beginning of treatment and throughout treatment duration,
at least every 2 months. In addition patients will require treatment with Entacavir
.5mg po qday per MSKCC institutional guidelines.

- No active co-morbid cardiac condition such as active CHF or CAD.

- KPS performance ≥ 70%.

- Histologically confirmed mantle cell lymphoma classified according to WHO criteria
confirmed at MSKCC.

- No prior treatment for mantle cell lymphoma with the exception of corticosteroids for
7 days or less or 1 course of involved-field radiation.

- No prior malignancies within 5 yrs, unless treated early stage breast cancer, treated
carcinoma in situ of the cervix, resected skin malignancies, or treated prostate

- Women who are pre-menopausal must have a negative serum pregnancy test. Subjects must
agree to use appropriate contraception until 4 weeks after the completion of

- Patients must be HIV negative, and have negative serologies for Hepatitis C.

Exclusion Criteria:

- Subjects who have current active hepatic or biliary disease (with exception of
patients with Gilbert's syndrome, asymptomatic gallstones, hepatic involvement by
MCL, or stable chronic liver disease per investigator assessment).

- Known pregnancy or breast-feeding.

- Medical illness unrelated to MCL within the prior one month that will preclude
administration of chemotherapy safely. This includes patients with uncontrolled
infection, chronic renal insufficiency, myocardial infarction within the past 6
months, unstable angina, active congestive heart failure, cardiac arrhythmias other
than chronic atrial fibrillation and chronic active or persistent hepatitis.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

single agent efficacy (as determined by response rate)

Outcome Description:

of the monoclonal antibody ofatumumab alone in low risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Paul Hamlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

September 2013

Related Keywords:

  • Mantle Cell Lymphoma
  • Bendamustine HCL
  • Ofatumumab (GSK 1841157)
  • Immunotherapy
  • Chemoimmunotherapy
  • 11-050
  • Lymphoma
  • Lymphoma, Mantle-Cell



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021