Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT01665768
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Everolimus — 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.
  • Rituximab — BIOLOGICAL
    375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)

Study Details

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.

Key Dates

Start date
Sep 30, 2012
Status verified
Oct 2021
Primary completion
Oct 31, 2017
Completion
Aug 31, 2020

Study Design

Enrollment
56 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Everolimus and Rituximab
    Everolimus daily for one year and IV rituximab four times during that year.

Primary Outcome Measure

Safety as Assessed by Avoidance of Grade 3-4 Adverse Events [ Time Frame: Up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-

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By research site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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