Overview

IPI-145 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn if IPI-145 can help to control the disease in patients with ALL. The safety of the study drug will also be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Infinity Pharmaceuticals, Inc.
Criteria
Inclusion Criteria:

1. Previously treated ALL (including Burkitt's lymphoma, lymphoblastic lymphoma) in
relapse or primary refractory. Patients with ALL or B or T cell origin may be treated.
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 of normal [ULN], unless considered due to tumor), and renal function (creatinine mg/dL). Even if organ function abnormalities are considered due to tumor, the upper
limit for bilirubin is
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 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 3 months.

5. Peripheral lymphoblasts > 50 x 109/L.

6. Pregnant and breast-feeding patients are excluded.

7. Patients with known hepatitis B or C are excluded.