MDACC Study Summary 2010-0991

Study Summary
No. 2010-0991:.......Leukemia......Hagop Kantarjian......Leukemia

Study Summary Title



Study Summary Number:	2010-0991

Study Title:	Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) with Low-intensity Chemotherapy in Patients with Acute Lymphoblastic Leukemia (ALL)

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:	Pfizer

Phase of Study:	Phase I/Phase II	Return Visit:

Treatment Agents:	6-mercaptopurine ARA-C Hyper-CVAD Inotuzumab Ozogamicin Methotrexate Prednisone Rituximab Vincristine	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:

Description/
Intervention:

The goal of the Phase I part of this clinical research study is to test 2 dose
levels of the drug inotuzumab ozogamycin to find the highest tolerable dose
that can be given in combination with chemotherapy. The goal of Phase II is to
learn if inotuzumab ozogamycin given in combination with chemotherapy can help
to control ALL. The safety of the study drugs will also be studied.

Inotuzumab ozogamycin is designed to attach to a protein that is often found in
leukemia cells. This may cause the cancer cells to die.

Rituximab is designed to attach to cancer cells and damage them, which may
cause the cells to die.

Hyper-CVAD includes a combination of cyclophosphamide, vincristine,
dexamethasone, methotrexate, Ara-C (cytarabine), and Neulasta (pegfilgrastim).
The maintenance therapy used in this study is called POMP, which includes a
combination of mercaptopurine, methotrexate, vincristine, and prednisone.
These chemotherapy drugs are designed to interfere with the multiplication of
cancer cells, which may slow or stop their growth and spread throughout the
body. This may cause the cancer cells to die.

Study Objectives / Outcomes

Phase I: Determine the maximum tolerated dose (MTD) of inotuzumab ozogamycin in combination with low-intensity chemotherapy in elderly patients (age 60 or older) with ALL.

Phase II:

a. Evaluate the efficacy of inotuzumab ozogamycin in combination with low-intensity chemotherapy in elderly patients with ALL. To evaluate the side effects of the treatment.

b. Evaluate the regimen efficacy in refractory-relapsed ALL.

Primary Study Endpoint
a. Phase I: Define the dose limiting toxicities (DLTs) and MTD.
b. Phase II: Evaluate progression-free survival (PFS) ) in frontline elderly ALL.
c. Evaluate response rate and survival in refractory-relapsed ALL.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	08/26/2011

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

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) Patients age 60 years or older with previously untreated ALL of pre-B, Philadelphia chromosome (Ph-) negative ALL. Minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed.

2) Zubrod performance status 0-3.

3) Adequate liver function (bilirubin </= 1.5 mg/dL and SGPT or SGOT </= 3 x upper limit of normal [ULN], unless considered due to tumor), and renal function (creatinine </= 2 mg/dL). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dL and creatinine </= 3 mg/dL.

4) Provision of written informed consent.

5) Patients in first remission are eligible.

6) Patients with refractory-relapsed ALL of any age are eligible, provided they are not eligible for regimens of higher priority. Currently study 2012-0151 (inotuzumab vs. intensive chemotherapy in ALL salvage 1 and 2) is an FDA pivotal trial and is a higher priority (September 10, 2012).

Exclusion Criteria:

1) Ph-positive ALL, Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma.

2) Patient with active heart disease (NYHA class >/= 3 as assessed by history and physical examination).

3) Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 40% are excluded.

4) Patients with active hepatitis are excluded.

5) Pregnant or breast-feeding women are excluded.

Links

Registration Number: NCT01371630
Study Information on Clinical Trials Registry (clinicaltrials.gov)