Overview

CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)

Status:
Completed
Trial end date:
2018-04-18
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn if CMC-544 given alone, and possibly given in combination with rituximab, can help to control the disease in patients with ALL. The safety of the study drug(s) will also be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Inotuzumab Ozogamicin
Rituximab
Criteria
Inclusion Criteria:

1. Previously treated ALL (including Burkitt's lymphoma and lymphoblastic lymphoma) in
relapse or primary refractory. Patients in first relapse will be eligible regardless
of the first remission duration. At least 10 patients in Salvage 1-2 will be treated
to assess anti-ALL response more precisely.

2. Age 16 years or older. Pediatric patients (<16 years old) will be allowed into the
study after safety is established, that is at least 10 adult patients having received
1 or more cycles each.

3. Zubrod performance status 0-3.

4. Adequate liver function (bilirubin Aspartate transaminase (SGOT) due to tumor), and renal function (creatinine abnormalities are considered due to tumor, the upper limit for bilirubin is mg/dL and creatinine
5. Male and female patients who are of childbearing potential agree to use an effective
barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to
avoid pregnancy. Female patients need a negative serum or urine pregnancy test within
14 days of study start (applies only if patient is of childbearing potential.
Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized).

Exclusion Criteria:

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

2. Patients with a cardiac ejection fraction (as measured by either Radionuclide
angiography (MUGA) or echocardiogram) < 45% are excluded.

3. Patients who receive other chemotherapy. Patients must have been off previous therapy
for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of
all previous therapy prior to enrollment (consent signing). (Concurrent therapy for
central nervous system [CNS] prophylaxis or treatment for CNS relapse is permitted).
Treatment may start earlier if necessitated by the patient's medical condition (e.g.
rapidly progressive disease) following discussion with the Principal Investigator.

4. Prior allogeneic stem cell transplant in previous 4 months.

5. Peripheral lymphoblasts > 50 x 10^9/L.

6. Pregnant and breast-feeding patients are excluded.

7. Patients with known hepatitis B are excluded.