Treatment of B-Chronic Lymphocytic Leukemia (B-CLL) With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells - Full Text View

Sponsor:	Baylor College of Medicine
Collaborators:	The Methodist Hospital System Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00458679

Purpose

The purpose of this research study is to determine the safety and effectiveness of special cells that may make the patient's own immune system fight chronic lymphocytic leukemia (CLL).

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia (CLL)	Genetic: IL2	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prolonged Immunization With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells for Treatment of B-Chronic Lymphocytic Leukemia (B-CLL)

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: CD40 Ligand

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

Toxicity: 2-week period after the eighth injection of vaccine (week 14) will be considered for toxicity evaluation [ Time Frame: 2 years post first injection ] [ Designated as safety issue: Yes ]
Safety: Consist of toxicity evaluation, adverse events, and serious adverse events during the entire time period of vaccination and stratified by time points (e.g. during the first 8 injections, during the second course, and the last 6 injections). [ Time Frame: 2 years post first injection ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	December 2006
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Intervention Details:

18 deltoid injections over 52 weeks

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Eligibility for blast collection:
Patients are eligible for administration of their vaccine if they present with B-CLL (not in Richter's transformation) with measurable disease.
Procurement consent signed and faxed to Research Coordinator
Eligibility for Vaccine Administration (protocol entry)
Manipulated B-CLL cells available (at least 12 injections)
Patients are eligible for administration of their vaccine if they present with B-CLL (not in Richter's transformation) with measurable disease
Patients must have a life expectancy of at least 10 weeks.
Patients must have ECOG performance status of 0-2 as below:
- Grade 0: Up and about, no restriction.
- Grade 1: Ambulatory, no strenuous activity.
- Grade 2: Ambulatory, capable of self-care appropriate for age. Up and about > 50% of time, but unable to carry out any physical activities or attend school.
- Grade 3: Limited self-care only. Up and about < 50% of time.
- Grade 4: Disabled, no self-care. Bedridden or confined to chair.
Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and must have an absolute neutrophil count (ANC) of greater than or equal to 500/uL, absolute lymphocyte count (ALC) greater than or equal to 200/uL, hemoglobin greater than or equal to 8 g/dL and platelet count greater than or equal to 50,000/uL.
Patients must be willing to practice appropriate birth control methods during the study and for 3 months after the study is concluded. This includes total abstinence, oral contraceptives, an intrauterine device, contraceptive implants under the skin, contraceptive injections (Depo-Provera [Registered]). Contraceptive foam with a condom is allowed. The male partner should use a condom.
Patients must have adequate liver function (total bilirubin less than or equal to 1.5 mg/dl, SGOT less than or equal to 3 times normal, normal prothrombin time).
Patients must have adequate renal function (creatinine less than 3 times normal for age or creatinine clearance greater than 80 mg/min/1.73m^2).
Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side-effects. Patients will be given a copy of the consent form.
Patient must not have received treatment with other investigational agents within the last 4 weeks.

Exclusion Criteria:

Infected at time of protocol entry, or receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole).
HIV positive
Pregnant or lactating
Suffering from an autoimmune disease (including active graft-versus-host disease-GvHD, refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)
Receiving immunosuppressive drugs
Patients without adequate cardiac function (congestive heart failure, significant arrhythmia)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458679

Contacts

Contact: Malcolm K Brenner, MD, PhD	832-824-4671	mbrenner@bcm.tmc.edu
Contact: Helen E Heslop, MD	832-824-4662	hheslop@bcm.tmc.edu

Locations

United States, Texas
The Methodist Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Malcolm Brenner, MD 832-824-4663 mkbrenne@txccc.org
Principal Investigator: Malcolm Brenner, MD
Sub-Investigator: Larry Rice, MD
Sub-Investigator: Kelty Baker, MD
Sub-Investigator: Alex Preti, MD
Sub-Investigator: George Carrum, MD
Sub-Investigator: Helen E Heslop, MD
Texas Children's Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Malcolm K Brenner, MD 832-824-4671 mbrenner@bcm.tmc.edu
Sub-Investigator: Bambi J Grilley, MD
Sub-Investigator: Helen E Heslop, MD
Sub-Investigator: Gianpietro Dotti, MD
Sub-Investigator: H. ALEJANDRO PRETI, MD
Sub-Investigator: Heidi L Weiss, MD
Sub-Investigator: Lawrence Rice, MD

Sponsors and Collaborators

Baylor College of Medicine

The Methodist Hospital System

Center for Cell and Gene Therapy, Baylor College of Medicine

Investigators

Study Director:

Malcolm K Brenner, MD

Center for Cell and Gene Therapy, Baylor College of Medicine

More Information

No publications provided

Responsible Party:	Malcolm Brenner, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00458679 History of Changes
Obsolete Identifiers:	NCT00602121
Other Study ID Numbers:	19747-PRIMAL, PRIMAL
Study First Received:	April 9, 2007
Last Updated:	August 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:

B-CHRONIC
LYMPHOCYTIC
LEUKEMIA

B-CLL
Chronic Lymphocytic Leukemia
CLL

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012