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

CompletedPhase 2

Sponsor: M.D. Anderson Cancer Center

Conditions: Acute Lymphoblastic Leukemia

Interventions: CMC-544 (Inotuzumab Ozogamycin), Rituximab

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 \</= 1.5 mg/dL and Alanine transaminase (SGPT) or Aspartate transaminase (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.
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.

Locations (1)

Houston, Texas, United States