MDACC Study Summary 2008-0519

Study Summary
No. 2008-0519:.......Leukemia......Hagop Kantarjian......Leukemia

Study Summary Title



Study Summary Number:	2008-0519

Study Title:	A PHASE I STUDY OF DT2219ARL (IND# 100780), A BISPECIFIC SINGLE CHAIN IMMUNOTOXIN FOR THE TREATMENT OF CD19 (+), CD 22 (+) B-LINEAGE LEUKEMIA OR LYMPHOMA

Physician

New Patient Referral



Name:	Hagop Kantarjian	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:	713-792-7026 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Scott & White Cancer Research Institute University of Minnesota Cancer Center

Phase of Study:	Phase I	Return Visit:	Every 1-2 weeks

Treatment Agents:	DT2219ARL	Home Care:	None

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	About 8 days

Description/
Intervention:

The goal of this clinical research study is to find the highest tolerable dose
of DT2219ARL that can be given to patients with ALL. The safety of DT2219ARL
will also be studied.

Pharmacokinetic (PK) testing and pharmacodynamic (PD) testing will also be
studied. PK testing measures the amount of study drug in the body at different
time points. PD testing is used to look at how the level of study drug in your
body may affect the disease.

Study Objectives / Outcomes

1. To determine the toxicities and maximum tolerated dose (MTD) of DT2219ARL (a bispecific recombinant immunotoxin [IT] targeting the CD19 and CD22 cell surface antigens) given as a 4 hour intravenous (IV) infusion every other day x 4 to patients with CD19+, CD22+ B-lineage leukemia refractory to other forms of therapy.

2. To determine the pharmacokinetic (PK) profile (Cmax, T1/2, AUC, Cl, Vd) of DT2219ARL.

3. To determine any therapeutic activity of DT2219ARL within the confines of a Phase I study as determined by the change in percentage of blasts in bone marrow and peripheral blood and recovery of normal hematopoiesis.

4. To measure levels of human anti-DT2219ARL antibodies.

5. To determine if there is a correlation between PK parameters and toxicity or response.

6. To determine if the expression of the CD19 and CD22 cell surface antigens is affected by treatment with DT2219ARL using flow cytometric analysis of lymphoblasts in peripheral blood and bone marrow and whether the CD19 and CD22 surface antigen expression on patient blasts correlate with response.

Study Status Information



Study Activation / Registration Date:	06/18/2009

IRB Review and Approval Date:	09/26/2008

Study Type:	Phase I

Recruitment Status:	Open

Projected Accrual:	30

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) Age > 12 years.

2) Histologic verification of B-cell lineage leukemia or lymphoma and evidence of relapse / refractory disease.

3) Disease refractory to conventional therapy and other therapies of higher priority.

4) Presence of CD19 and/or CD22 on at least 50% of the lymphoblasts or lymphoma cells obtained via bone marrow aspirate or peripheral blood as determined by flow cytometry or node biopsy.

5) ECOG performance 0-2.

6) Patients must have recovered from effects of prior therapy. At least 2 weeks should have elapsed since the last dose of chemotherapy

7) Patients who have recovered from the side effects of prior therapy and have a > 50% rise in peripheral blast count (confirmed twice) or > 50% growth of lymph nodes are immediately eligible

8) In order to prevent tumor lysis syndrome, leukemia patients must have a peripheral blast count under 50 x 10^9/L. This should be achieved with hydroxyurea cytoreduction, prior to starting DT2219ARL as follows. In patients with peripheral blasts and a white blood cell (WBC) >50 x 10^9/L, give hydroxyurea 1-5 g daily for up to 5 days, to reduce WBC below 50 x 10^9/L.

9) Patients who have relapsed following autologous or allogeneic bone marrow transplant (BMT) are eligible.

10) Adequate renal function defined as a serum creatinine </= 1.5 x upper limit of the normal range.

11) Adequate liver function defined as a total bilirubin </= 1.5 x upper limit of the normal range and SGOT (AST) or SGPT (ALT) < 2.5 x upper limit of the normal range.

12) Adequate cardiac function defined as an ejection fraction of >/= 40% by MUGA scan or echocardiography.

13) Women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study.

14) Serum albumin must be at least 3.0g/dL.

15) Life expectancy >12 weeks and < 6 months.

Exclusion Criteria:

1) Presence of leukemic or infectious pulmonary parenchymal disease.

2) Presence of CNS leukemia. CSF with < 5 WBC/uL will not exclude the patient.

3) Presence of any uncontrolled systemic infection.

4) Documented seizure disorder or abnormal neurological examination.

5) Documented penicillin or cephalosporin allergies.

6) Pregnant and breast feeding women are excluded.

Links

Registration Number: NCT00889408
Study Information on Clinical Trials Registry (clinicaltrials.gov)