Imprime PGG, Alemtuzumab, and Rituximab in Treating Patients With High Risk Chronic Lymphocytic Leukemia

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT01269385
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • B-cell Chronic Lymphocytic Leukemia
  • Refractory Chronic Lymphocytic Leukemia
  • Stage 0 Chronic Lymphocytic Leukemia
  • Stage I Chronic Lymphocytic Leukemia
  • Stage II Chronic Lymphocytic Leukemia

Eligibility Criteria

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

Interventions

  • alemtuzumab — BIOLOGICAL
    Given subcutaneously
  • rituximab — BIOLOGICAL
    Given IV
  • PGG beta-glucan — DRUG
    Given IV
  • flow cytometry — OTHER
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • DNA analysis — GENETIC
    Correlative studies
  • fluorescence in situ hybridization — GENETIC
    Correlative studies
  • polymerase chain reaction — GENETIC
    Correlative studies
  • polymorphism analysis — GENETIC
    Correlative studies
  • mutation analysis — GENETIC
    Correlative studies

Study Details

RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can kill chronic lymphocytic leukemia (CLL) cells and are effective therapies for this disease. Biological therapies, such as Imprime PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose), may stimulate the immune system in different ways and help monoclonal antibodies kill CLL cells. Giving PGG beta-glucan together with alemtuzumab and rituximab could make therapy with monoclonal antibodies, such as alemtuzumab and rituximab, more effective. PURPOSE: This phase I/II trial is studying the side effects and best dose of PGG beta-glucan when given together with alemtuzumab and rituximab and to see how well it works in treating patients with earlier stage high-risk chronic lymphocytic leukemia.

Key Dates

Start date
Jan 31, 2011
Status verified
Aug 2018
Primary completion
Jun 30, 2014
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: Arm I
    Patients receive PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31; alemtuzumab subcutaneously on days 3, 4, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; and rituximab IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of PGG Beta Glucan in Combination With Alemtuzumab and Rituximab Assessed by Analyzing the Number of Dose-limiting Toxicity Events (Phase I) [ Time Frame: First cycle of treatment (35 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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By research site
Mayo Clinic· Rochester, MN

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