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



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/4/2018
Start Date:September 2011
End Date:September 2019

Use our guide to learn which trials are right for you!

This study is being done to understand how to treat Mantle Cell Lymphoma (MCL). The goals of
treatment are to control the lymphoma with the least amount of side effects. In many cases,
MCL is treated with an antibody plus chemotherapy. An antibody is a laboratory-produced
substance created to attach to proteins on the cancer cells, eventually destroying them.
Chemotherapy is medicine that specifically destroys cancer cells.

The purpose of this study is to find out what effects, good and/or bad, the drugs Ofatumumab
and Bendamustine have on this type of cancer. Patients in this study will either receive
Ofatumumab alone, or Ofatumumab combined with Bendamustine.


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
factors:

- 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
HDT/ASCT.

- 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
cancer.

- 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
chemotherapy.

- 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.
We found this trial at
6
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Paul Hamlin, MD
Phone: 212-639-6143
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
Phone: 212-639-6143
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
?
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials
Commack, New York 11725
Phone: 212-639-6143
?
mi
from
Commack, NY
Click here to add this to my saved trials
500 Westchester Avenue
Harrison, New York 10604
?
mi
from
Harrison, NY
Click here to add this to my saved trials
Rockville Centre, New York 11570
Phone: 212-639-6143
?
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
701 N Broadway
Sleepy Hollow, New York 10591
(914) 366-3000
Phone: 212-639-6143
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Memorial Sloan Kettering Cancer Center Sleepy...
?
mi
from
Sleepy Hollow, NY
Click here to add this to my saved trials