MDACC Study Summary 2008-0313

Study Summary
No. 2008-0313:.......Leukemia......Marina Konopleva......Leukemia

Study Summary Title



Study Summary Number:	2008-0313

Study Title:	Therapy Targeting the Interleukin-3 Receptor (IL3R) for Patients with Relapsed or Refractory and Elderly or Poor-Risk Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome with DT388IL3 (IND#11314): a Phase I/II Clinical Trial

Physician

New Patient Referral



Name:	Marina Konopleva	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:	713-794-1628 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Patients with AML or MDS will require lab reviews twice a week and physician's visit twice a month.

Treatment Agents:	DT388IL3	Home Care:	Only supportive care (antibiotics, antifungals, antiviral) medications will be given at home.

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

Estimated Length of Stay in Houston:	Hospitalization is required for administration of the agent for 3-8 days. For patients not on Medicare, third party payor or hospital pre-approval must be obtained.


Description/ Intervention:	The goal of this clinical research study is to find the highest safe dose of DT388IL3 that can be given to patients with AML, high-risk myelodysplasia, or poor-risk myeloid leukemia. The effectiveness of this drug will also be studied.

Study Objectives / Outcomes

1.Estimate the maximal tolerated dose (MTD) of DT388IL3 fusion protein as a bolus IV infusion for 5 daily doses in patients with refractory or relapsed AML, MDS which has evolved to AML, or poor-risk AML, or high risk MDS.
2. Define the dose-limiting toxicities (DLT) of this DT388IL3 regimen in these patients.
3. Measure the pharmacokinetics and immune responses associated with this DT₃₈₈IL3 regimen.
4. Evaluate response and correlate with patient disease burden and IL3 receptor density.

Study Status Information



Study Activation / Registration Date:	12/09/2008

IRB Review and Approval Date:	08/11/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	90

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) All patients must be informed about the study and signed informed consent.

2) All patients must have acute myeloid leukemia, or high risk myelodysplastic syndrome diagnosed by morphologic, histochemical or cell surface marker criteria.

3) Patients with AML must have either (a) relapsed or refractory leukemia after receiving at least one prior conventional induction therapy. Those in early first relapse must not have a matched donor and/or are not a candidate for allogeneic stem cell transplantation; (b) poor-risk AML.

4) Treatment related AML, except if it is associated with favorable cytogenetics (e.g.: inversion 16, t(17;16), t(8.21), t(15;17), and not a candidate for stem cell transplantation.

5) AML with antecedent hematological disease (e.g. MDS, myelofibrosis, polycythemia vera, etc.), and not a candidate for stem cell transplantation.

6) De novo AML >/= 70 years of age.

7) AML with unfavorable cytogenetics regardless of age (>/=18 years), if patients are not candidates for allogeneic transplantation (unfavorable cytogenetics are the following: complex (>/=3 abnormalities), -7, -5, 7q-, 5q-, abnormalities of 11q23, excluding t(9;11), t(9;22), inversion 3, t(3;3), t(6;9)).

8) Patients with chemotherapy resistant or intolerant high risk myelodysplastic syndrome diagnosed by morphologic, histochemical or cell surface marker criteria, either according to the FAB or the WHO classification will be eligible. These patients must not be eligible or willing to undergo immediate allogeneic stem cell transplantation.

9) Patients must have a performance status of </= 2 on the Zubrod scale.

10) Patients must have bilirubin </= 1.5 mg/dl, transaminases </= 2.5x upper limit of normal, albumin >/= 3gm/dl, creatinine </= 1.3mg/dl, and adequate cardiac reserve (EF>50%).

11) Must give written informed consent.

12) Must be willing to be treated at an approved treatment site.

13) Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion.

14) Age > 18 years.

15) Patient's disease burden must be low with a blast marrow index of </= 40%. Blast marrow index is calculated from the product of the marrow biopsy cellularity and the blast percentage (% cellularity X % blasts).

16) Patients must have a 24 hour creatinine and urea clearance. Average of the two measurements must be >/= 60 cc per minute.

Exclusion Criteria:

1) Inability to give informed consent because of psychiatric problems, or complicated medical problems.

2) Serious concurrent medical problems, uncontrolled infections, DIC or pregnancy.

3) Active CNS leukemia.

4) Patients who have had a myocardial infarction within the past six months.

5) Pregnant or nursing women will be excluded from study.

6) Patients with allergies to diphtheria toxin will be excluded.

7) Patients requiring oxygen will be excluded from the study.

8) History of congestive heart failure.

Links

Registration Number: NCT00397579
Study Information on Clinical Trials Registry (clinicaltrials.gov)