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

Study results available
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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

Everolimus

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

Rituximab

375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)

Sponsors & Collaborators

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01665768 on ClinicalTrials.gov