Overview

Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia

Status:
Not yet recruiting
Trial end date:
0000-00-00
Target enrollment:
48
Participant gender:
All
Summary
The goal of this clinical research study is to learn if inotuzumab ozogamycin can help to control the disease in participants with acute lymphocytic leukemia (ALL). The safety of this treatment will also be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Pfizer
Last Updated:
2017-04-19
Criteria
Inclusion Criteria:

1. Patients at least 12 years of age.

2. Patients with a diagnosis of CD22-positive ALL (ie, >/=10% blasts CD22-positive)
based on local immunophenotyping and histopathology) who have: a.Refractory disease,
defined as disease progression or no response while receiving their most recent prior
anti-cancer therapy., b.Relapsed disease, defined as response to their most recent
prior anti-cancer therapy with subsequent relapse.

3. Performance status of 0 to 3.

4. Adequate renal function including serum creatinine (ULN) or estimated creatinine clearance >/= 15 mL/min as calculated using the method
standard for the institution.

5. Adequate liver function, including total serum bilirubin patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase
(AST or ALT) tumor, total serum bilirubin must be
6. No active or co-existing malignancy requiring chemotherapy or radiation within 6
months.

7. Female subjects of childbearing potential should be willing to use effective methods
birth control or be surgically sterile, or abstain from heterosexual activity for the
course of the study. Subjects of childbearing potential are those who have not been
surgically sterilized or have not been free from menses for > 1 year. Effective
methods of birth control include birth control pills or injections, intrauterine
devices (IUDs), or double-barrier methods (for example, a condom in combination with
spermicide).

8. Male subjects should agree to use an effective method of contraception starting with
the first dose of study therapy through the duration of treatment.

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. Prior allogeneic stem cell transplantation (ASCT) or other anti-CD22 immunotherapy
within
7. Active CNS or extramedullary disease unless approved by the PI.

8. Monoclonal antibodies therapy within 2 weeks before study entry

9. Radiotherapy and cancer chemotherapy (except for intrathecal chemotherapy,
hydroxyurea, and cytarabine. Cytarabine and hydroxyurea are allowed to be used
emergently in case of leukocytosis) or any investigational drug within 2 weeks before
study entry.

10. Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction
syndrome (SOS)