MDACC Study Summary 2004-0914 (Archived)

Study Summary
No. 2004-0914:.......Leukemia......William G. Wierda......Leukemia

Study Summary Title



Study Summary Number:	2004-0914

Study Title:	A Phase I Trial of Autologous CLL B Cells Transduced to Express Chimeric CD154 (ISF35)

Physician

New Patient Referral



Name:	William G. Wierda	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-0428 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Day 3 after the infusion, then weekly for 4 weeks. Then monthly for 2 months. Then quarterly for one year after last infusion.

Treatment Agents:	ISF35-Transduced Cells	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Outpatient


Description/ Intervention:	The goal of this clinical research study is to evaluate the safety and side effect profile of ISF35 and to learn if ISF35 can stimulate the immune system and help to control CLL.

Study Objectives / Outcomes

Primary Objective
Assess the toxicities, tolerability, and safety of a single infusion of 1x10⁸, 3x10⁸, and 1x10⁹ autologous Ad-ISF35-transduced CLL B cells (ISF35) given intravenously in up to 18 patients with CLL.

Secondary Objectives
- Assess the anti-leukemia activity of ISF35 by evaluating reduction in leukemia count, reduction in adenopathy and splenomegaly, and improvement in bone marrow function.
- Assess the quality of life with ISF35 treatment.
- Assess pharmacodynamic endpoints including induction of T cell anti-leukemia immune responses, antibody production against autologous CLL B cells, changes in bystander leukemia cell phenotype including expression of co-stimulatory molecules (CD80 and CD86) and apoptosis-related receptors (CD95 and DR5), expression of intracellular pro- and anti-apoptotic proteins and effector caspases, and changes in plasma cytokine levels.

Study Status Information



Study Activation / Registration Date:	05/19/2006

IRB Review and Approval Date:	04/12/2005

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Subjects must have a diagnosis of B cell CLL, measurable disease, and an NCI-WG indication for treatment: -Massive/progressive splenomegaly -Massive/progressive lymphadenopathy -Progressive anemia -Progressvie thrombocytopenia -Weight loss (10%) in preceeding 6 mo -Fatigue -Fever/night sweats without infection -Progressive lymphocytosis

2) Subjects must be age 18 years or older.

3) Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. Both men and women participants must agree to use contraception for the duration of the study.

4) Subjects must have Zubrod performance status of less than or equal to 2.

5) Subjects must have adequate hematologic, renal, hepatic, and coagulation function. -PLT>/=50K; HGB>/=10g/dL; sCr</=1.5xULN; CrCl >/=40; T bili </= 2.5xULN; ALT</=2.5xULN; PT INR </=2; PTT</= 1.66xULN.

6) Subjects must be able to give written informed consent.

Exclusion Criteria:

1) Presence of more than 55% prolymphocytes.

2) Chemotherapy (e.g., purine analogues, alkylating agents, or corticosteroids), antibody therapy, immunotherapy, radiation therapy, or participation in any investigational drug treatment within 4 weeks of enrollment into protocol or at any time during the study.

3) Ongoing toxicity from prior anti-neoplastic therapy.

4) Prior gene therapy or allogeneic stem cell transplantation.

5) Untreated autoimmune hemolytic anemia or immune thrombocytopenia.

6) Active infection requiring parenteral antibiotics.

7) Known HIV/HBV/HCV seropositivity.

8) Uncompensated hypothyroidism (defined as TSH greater than 4x upper limit of normal not treated with replacement hormone). To receive up to two repeat infusions of ISF35 transduced autologous CLL cells, subjects must have additional cells available, and continue to fulfill the Eligibility Criteria.

Links

Registration Number: NCT00779883
Study Information on Clinical Trials Registry (clinicaltrials.gov)