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A Trial of Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in CD20+, B-cell Lymphomas and Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
CD20+, B-cell Lymphomas, Mantle Cell Lymphoma, Non-Mantle Cell Low Grade B Cell Lymphomas (SLL/CLL), Transformed Lymphoma/DLBCL/PMBCL, Hodgkin's Disease

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Trial Information

A Trial of Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in CD20+, B-cell Lymphomas and Hodgkin's Lymphoma


Everolimus is a pill that interferes with lymphoma cell growth by blocking a cellular
pathway important in causing cancer cells to grow, called mTor. Rituximab is an intravenous
medication that specifically attacks a protein commonly found on lymphoma cells called CD20.

Rituximab is already widely used to treat multiple forms of lymphoma. Moreover, continuing
rituximab after the completion of chemotherapy is already commonly used to help patients
stay in remission longer. Everolimus has been shown in many types of relapsed lymphoma to
decrease the size of lymph nodes by itself. Everolimus is approved by the Food and Drug
Administration (FDA) for the treatment of advanced kidney cancer and subependymal giant cell
astocytoma. It is not approved for use in lymphoma. The use of everolimus in this research
study is investigational. The word "investigational" means that everolimus is not approved
for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of
everolimus in this study.

The combination of everolimus and rituximab for 1 year after high dose therapy is also new.
We believe the combination of these medications right after your chemotherapy will be more
effective in attacking your remaining cancer before they have time to re-grow.

The usual treatment of lymphoma after high-dose chemotherapy is observation. After your
body has fully recovered from the effects of the chemotherapy, you will receive everolimus
daily for one year and IV rituximab four times during that year.


Inclusion Criteria:



- Age >18 years of age

- ECOG performance status ≤ 2

- INR ≤ 2

- Adequate renal and hepatic function defined as a serum creatinine <2.0mg/dL, total
bilirubin <5mg/dL, and AST and ALT ˂ 2.5 ULN.

- Platelet count >75 x 109/L

- Hemoglobin >10mg/dL

- ANC >3.0x109/L

- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L and fasting triglycerides ≤ 2.5
x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can
only be included after initiation of appropriate lipid lowering medication.

- A willingness to use an accepted and effective method of birth control for sexually
active women of childbearing potential during the study and for 8 weeks after the end
of study drug treatment.

- Ability to sign informed consent

Exclusion Criteria:

- Patient who have previously received an mTor inhibitor

- Patients who are pre-terminal or moribund

- Patients with active bacterial of fungal infections requiring oral or intravenous
antimicrobials are not eligible until resolution of the infection

- Female patients who are pregnant or breast feeding, or of reproductive potential who
are not using effective birth control methods. Adequate contraception must be used
throughout the trial and for 8 weeks after the last dose of study drug.

- Patients with known intolerance to rituximab

- HIV positive, Hepatitis B positive, Hepatitis C positive individuals

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients with adverse events when given treatment with maintenance rituximab and prolonged mTOR inhibition with everolimus in CD20+, B cell lymphomas and Hodgkin's Lymphoma after high-dose consolidative therapy

Outcome Description:

• Avoidance of ≥ grade III common toxicities (CTCAE version 4.0)

Safety Issue:

Yes

Principal Investigator

Douglas Gladstone, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

J1228

NCT ID:

NCT01665768

Start Date:

August 2012

Completion Date:

Related Keywords:

  • CD20+, B-cell Lymphomas
  • Mantle Cell Lymphoma
  • Non-Mantle Cell Low Grade B Cell Lymphomas (SLL/CLL)
  • Transformed Lymphoma/DLBCL/PMBCL
  • Hodgkin's Disease
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Mantle-Cell

Name

Location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410