Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab

Part of paid clinical trials in Lakeland, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT00609869
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    Lenalidomide was administered orally with escalating doses on 28-days cycles. The first cycle was administered with a starting dose of 2.5 mg daily on days 1-7, 5mg on days 8-14 and 10 mg on days 15-21, followed by seven days off. On cycle 2 and beyond lenalidomide was administered at 20 mg daily on days 1-21.
  • Rituximab — DRUG
    Rituximab was administered at 375 mg/m\^2 intravenously on a weekly basis for the first cycle starting on day 15. Subsequent rituximab doses were administered on day one of cycle 2 and beyond, every 4 weeks. Doses were repeated on 28-day cycles until disease progression or unacceptable toxicity, but were planned for 12 cycles.

Study Details

The purpose of this research is to evaluate the use of Rituximab in combination with Revlimid in the treatment of refractory Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL). Revlimid® is a drug that changes the immune system and it may also get in the way with the growth of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug Administration (FDA) for the treatment of specific types of Myelodysplasia syndrome (MDS) and Multiple Myeloma, two different types of blood cancer. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.

Key Dates

Start date
Oct 31, 2007
Status verified
Sep 2015
Primary completion
Feb 28, 2014
Completion
Aug 31, 2015

Study Design

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

Arms

  • Experimental: Lenalidomide and Rituximab
    28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously. Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles. Rituximab: at 375 mg/m\^2 on a weekly basis for the first cycle starting on day 15.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 6 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Center for Cancer Care & Research/WatsonLakelandFlorida33805-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Lakeland, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Center for Cancer Care & Research/Watson· Lakeland, FLH. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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