Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
NCT01665768 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2021-10-26
Summary
This research is being done to determine if combining an investigational drug called Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose chemotherapy.
Conditions
- CD20+, B-cell Lymphomas
- Mantle Cell Lymphoma
- Non-Mantle Cell Low Grade B Cell Lymphomas (SLL/CLL)
- Transformed Lymphoma/DLBCL/PMBCL
- Hodgkin's Disease
- Gray Zone Lymphoma
Interventions
- DRUG
-
The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL.
- BIOLOGICAL
-
375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)
Sponsors & Collaborators
- collaborator INDUSTRY
-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
lead OTHER
Principal Investigators
-
Douglas Gladstone, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-09-30
- Primary Completion
- 2017-10-31
- Completion
- 2020-08-31
Countries
- United States
Study Locations
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