A Phase 1-2 Study of CAT-8015 in Adult Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

This study has been suspended.

First Received on March 12, 2010.  
Last Updated on August 18, 2012  
History of Changes
This Clinical Trial Sponsored By: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01086644
 

Purpose for Clinical Trial

Background:

– CAT-8015 is a modified monoclonal antibody that was designed in the laboratory to target, attack, and destroy specific cancer cells. Researchers are interested in determining the best and safest dose of CAT-8015 to treat patients with specific kinds of lymphoma, such as B-cell non-Hodgkin’s lymphoma or chronic lymphocytic leukemia, that have not responded well to standard treatments or therapies.

Objectives:

– To determine the optimal and maximum tolerated dose of CAT-8015 to treat relapsed or refractory selected types of lymphoma.

Eligibility:

– Individuals at least 18 years of age who have been diagnosed with B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, or other selected types of lymphoma, who have not responded well to standard treatments or therapies.

Design:

  • Eligible individuals will be asked to provide a blood sample for DNA analysis before receiving CAT-8015.
  • Participants will receive intravenous infusions of CAT-8015 in 28-day treatment cycles. Infusions will be given on Days 1, 3, and 5 of each cycle.
  • Participants will receive different doses of CAT-8015 depending on when they enter the study, up to a maximum tolerated dose or optimum treatment dose.
  • Frequent blood and urine tests will be performed during treatment, as well as other tests as directed by the study doctors. Participants will receive medicines to help prevent possible adverse side effects of CAT-8015, such as allergic reactions or kidney problems.
  • At the end of the treatment cycles determined by study doctors, participants will begin a follow-up period with a visit 30 days after the last infusion of CAT-8015, and then every 3 months until the end of the study.

Condition Study Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Diffuse Large B-Cell Lymphoma (DLBCL)
Non-Hodgkin’s Lymphoma (NHL)
Follicular Lymphoma (FL)
Mantle Cell Lymphoma (MCL)
Drug: CAT-8015 Phase 1
Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1-2 Study of CAT-8015 in Adult Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Chronic Lymphocytic Leukemia
Leukemia
Lymphoma

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures For Clinical Trial:

  • To determine the maximum tolerated dose and safety profile of CAT-8015 in subjects with relapsed or refractory advanced B-cell Lymphoma, Follicular Lymphoma, Mantle cell Lymphoma and CLL. [ Time Frame: Study to last 29 months, the total study duration is 41 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures For Clinical Trial:

  • To describe the preliminary efficacy profile of CAT-8015 in patients with relapsed or refractory advanced B-cell NHL (DLBCL, FL, MCL) or CLL. [ Time Frame: Study to last 29 months, the total study duration is 41 months ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: February 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Active Comparator: Arm A

Only treat CLL, DLBCL, MCL
Drug: CAT-8015

20, 30, 40, 50, or 60 mcg/kg dose escalation on days 1, 3, 5 of each 28 day cycle
Active Comparator: Arm B

Only Treat FL
Drug: CAT-8015

20, 30, 40, 50, or 60 mcg/kg dose escalation on days 1, 3, 5 of each 28 day cycle
Active Comparator: Expansion Phase

CLL, CLBCL, MCL and FL will be broken into 4 individual groups
Drug: CAT-8015

20, 30, 40, 50, or 60 mcg/kg dose escalation on days 1, 3, 5 of each 28 day cycle

 
Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Eligibility

Histologically confirmed B-cell NHL (DLBCL, FL, MCL) and:

  • Have relapsed or refractory disease after at least one prior regimen containing rituximab, either alone or in combination.
  • Have measurable disease (at least one lesion greater than or equal to 20 mm in one dimension or greater than or equal to 15 mm in two dimensions by conventional or high resolution [spiral] computed tomography (CT).
  • Not be a candidate for, or opted not to receive, a hematopoietic stem cell (HSC) or bone marrow (BM) transplant.

OR, confirmation of B-cell CLL (including small lymphocytic lymphoma [SLL]), requiring treatment and:

  • Have a characteristic immunophenotype by flow cytometry.
  • Have relapsed or refractory disease after at least 2 prior lines of treatment, at least 1 of which must have contained rituximab.
  • Not be a candidate for, or opted not to receive, an HSC or BM transplant.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086644

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert J Kreitman, M.D. National Cancer Institute (NCI)

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