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Everolimus in Combination With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Phase 2
18 Years
Not Enrolling
Diffuse Large B-cell Lymphoma

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Trial Information

Everolimus in Combination With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Participants will receive oral Everolimus and intravenous rituximab for DLBCL that has
relapsed or been refractory to prior therapy.

- Each treatment cycle lasts 28 days (4 weeks). Everolimus will be taken orally, once
daily in the morning.

- Rituximab will be administered by an intravenous (IV) infusion on Days 1, 8, 15 and 22
of Cycle 1. In Cycles 2-6, rituximab will be administered only on Day 1 of each cycle.

- Participants will come into the clinic weekly during the first cycle, then on Day 1 of
all cycles thereafter. The following tests and procedures will be performed:

- Weekly During Cycle 1: blood tests

- Day 1 of all Subsequent Cycles: brief physical examination; review of current
medications, treatments, symptoms and side effects; vital signs; performance status
evaluation; blood tests.

- A full body CT and PET scan to assess the participants tumor will be done within 7 days
of completing cycles 2, 4, 6, 9 and 12.

Responding subjects may receive up to 6 cycles of Everolimus plus rituximab, and an
additional 6 months of oral Everolimus for participants continuing to respond.

Inclusion Criteria:

- Histologically determined DLBCL that is relapsed or primary refractory after initial

- Greater than 1 prior line of chemotherapy (including an anthracycline unless
contraindicated) or immunotherapy. Patients must have relapsed after autologous stem
cell transplantation, not be eligible for autologous stem call transplantation in the
judgment of the investigator, or refuse autologous stem cell transplantation.
Salvage chemotherapy and high dose conditioning for autologous stem cell
transplantation count as two separate regimens.

- Measurable disease that has not been previously irradiated on PET-CT of at least 2cm,
OR if the patient has had previous radiation to the marker lesion(s), there must be
evidence of progression since the radiation. Imaging must be completed no greater
than 3 weeks from study enrollment.

- ECOG performance status 0-2

- 18 years of age or older

- Life expectancy of greater than 3 months

- Adequate Organ and marrow function

- Fasting serum cholesterol of 300 mg/dl or less OR 7.75 mmol/L or less AND fasting
triglycerides 2.5 x ULN or less

Exclusion Criteria:

- Currently receiving anticancer therapies or who have received anticancer therapies
within 3 weeks of the start of the study drug

- Receiving any other investigational agents, or have received investigational agents
within 4 weeks of beginning treatment

- Major surgery or significant traumatic injury within 4 weeks of start of study drug,
patients who have not recovered from the side effects of any major surgery (defined
as requiring general anesthesia) or patients that may require major surgery during
the course of the study

- Known leptomeningeal or brain metastases. Imaging or spinal fluid analysis to
exclude CNS involvement is not required, unless there is clinical suspicion by the
treating investigator

- Known HIV infection

- Systemic fungal, bacterial, viral, or other infection not controlled

- Prior history of malignancy (except for non-melanoma skin cancer or in situ cervical
or breast cancer) unless disease free for at least one year. Patients with prostate
cancer are allowed if PSA is less than 1

- Patients should not receive immunization with attenuated live vaccines within one
week of study entry or during study period

- Severely impaired lung function defined as DLCO of <60%

- Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN

- Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent

- Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of Everolimus

- Active bleeding diathesis

- Female patients who are pregnant or breastfeeding, or adults of reproductive
potential who are not using effective birth control methods

- Prior treatment with an mTOR inhibitor

- Known hypersensitivity to murine antibodies,everolimus,other rapamycin

- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study

- No chronic treatment with systemic corticosteroids or other immunosuppressive agents.
Topical or inhaled corticosteroids are permitted

Type of Study:


Study Design:

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

Outcome Measure:

Determine clinical efficacy of Everolimus in combination with rituximab in relapsed/refractory DLBCL

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jeremy S. Abramson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

November 2011

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • rituximab
  • everolimus
  • mTOR
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



Massachusetts General HospitalBoston, Massachusetts  02114-2617
Beth Israel Deaconsess Medical CenterBoston, Massachusetts  02215