MDACC Study Summary 2010-0708

Study Summary
No. 2010-0708:.......Leukemia......Elias Jabbour......Leukemia

Study Summary Title



Study Summary Number:	2010-0708

Study Title:	Phase II Study of the Hyper - CVAD Regimen in Combination with Ofatumumab as Frontline Therapy for patients with CD-20 positive Acute Lymphoblastic Leukemia

Physician

New Patient Referral



Name:	Elias Jabbour	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:	713-792-4764 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	GSK

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Cytarabine HCVAD Methotrexate Ofatumumab	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to learn if ofatumumab combined with standard chemotherapy can help to control ALL. The safety of these drug combinations will also be studied.

Study Objectives / Outcomes

Primary Objectives:

To evaluate the clinical efficacy of the combination of hyper-CVAD + ofatumumab in patients with newly diagnosed acute lymphoblastic leukemia with any level of CD20 expression:
- Event-free survival
- Overall response rate
- Overall survival

Secondary Objectives:

To evaluate the safety of this combination.

Study Status Information



Study Activation / Registration Date:	07/12/2011

IRB Review and Approval Date:	07/12/2011

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 of all ages with newly diagnosed, previously untreated CD-20+ ALL, or lymphoblastic lymphoma, or having achieved CR with one course of induction chemotherapy.

2) Failure to one induction course of chemotherapy (these patients will be analyzed separately).

3) Performance status of 0, 1, or 2.

4) Adequate organ function with creatinine less than or equal to 3.0 mg/dL (unless considered tumor related), bilirubin less than or equal to 3.0 mg/dL (unless considered tumor related).

5) Adequate cardiac function defined as no history of arrhythmia, history of MI, or abnormal EKG within 3 months prior to study enrollment. Cardiac function will be assessed by history and physical examination

6) No active or co-existing malignancy(other than ALL or lymphoblastic lymphoma) with life expectancy less than 12 months due to that malignancy.

Exclusion Criteria:

1) Pregnant or nursing women.

2) Known to be HIV+

3) Ph+ ALL

4) Active and uncontrolled disease/infection as judged by the treating physician

5) Unable or unwilling to sign the consent form

6) Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)

7) Treatment with any known non – marketed drug substance or experimental therapy within 5 terminal half lives (calculated by multiplying the reported terminal half life by 5) or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study.

8) History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae

9) Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.

10) Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result

Links

Registration Number: NCT01363128
Study Information on Clinical Trials Registry (clinicaltrials.gov)