Pentostatin, Alemtuzumab, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Mayo Clinic
Study ID
NCT00669318
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • alemtuzumab — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • pentostatin — DRUG
  • sargramostim — DRUG

Study Details

RATIONALE: Drugs used in chemotherapy, such as pentostatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving pentostatin together with alemtuzumab and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving pentostatin together with alemtuzumab and rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Key Dates

Start date
Jul 31, 2008
Status verified
Jun 2014
Primary completion
May 31, 2013
Completion
May 31, 2014

Study Design

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

Arms

  • Experimental: Treatment (Pentostatin, Alemtuzumab, Rituximab)
    Course 1: Patients receive: * 2 mg/m\^2 pentostatin IV on days 8 and 22; * 3 mg alemtuzumab subcutaneously (SC) on day 3; * 10 mg alemtuzumab SC on day 4; * 30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; * 20 mg/m\^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; * 6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2. Courses 2 and 3: Patients receive: * 2 mg/m\^2 pentostatin IV on days 1 and 15; * 30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26; * 20 mg/m\^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26; * 6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3).

Primary Outcome Measure

Complete Response Rate [ Time Frame: Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Holden Comprehensive Cancer Center at University of IowaIowa CityIowa52242-1002-
Mayo ClinicRochesterMinnesota55905-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-

Find similar trials in Iowa City, IA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Holden Comprehensive Cancer Center at University of Iowa· Iowa City, IAMayo Clinic· Rochester, MNUniversity of Virginia Cancer Center· Charlottesville, VA

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