Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia

Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed. 2. Patients unfit ≥ 18 - \< 60 years of age with previously untreated ALL pre- B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible. These patients are defined as having at least one of the below comorbidities: 1. ECOG performance status ≥ 2 2. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina) 3. Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%) 4. Creatinine clearance \< 45 mL/min, and 5. Hepatic disorder with total bilirubin \> 1.5 x upper limit of normal <!-- --> 1. If they achieved CR, they are assessable only for event-free and overall survival, or 2. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival 3. Patients age 60 years and older unfit for intensive chemotherapy with one or more comorbidities (e.g., renal insufficiency, heart disease, cardio-vascular disease, uncontrolled hypertension, diabetes, respiratory problems, among others) and a PS of ≥ 1. All ages of Jehovah's witness are eligible. 4. Zubrod performance status 0-3. 5. Adequate liver function (bilirubin \< 1.95 mg/dL and SGPT or SGOT \< 3 x upper limit of normal \[ULN\], unless considered due to tumor), and renal function (estimated kidney function (creatinine clearance) at least 50 mL/min/1.73 m2). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \< 2.6 mg/dL and creatinine \< 3 mg/dL. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed. 2. Patients unfit ≥ 18 - \< 60 years of age with previously untreated ALL pre- B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible. These patients are defined as having at least one of the below comorbidities: 1. ECOG performance status ≥ 2 2. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina) 3. Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%) 4. Creatinine clearance \< 45 mL/min, and 5. Hepatic disorder with total bilirubin \> 1.5 x upper limit of normal <!-- --> 1. If they achieved CR, they are assessable only for event-free and overall survival, or 2. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival 3. Patients age 60 years and older unfit for intensive chemotherapy with one or more comorbidities (e.g., renal insufficiency, heart disease, cardio-vascular disease, uncontrolled hypertension, diabetes, respiratory problems, among others) and a PS of ≥ 1. All ages of Jehovah's witness are eligible. 4. Zubrod performance status 0-3. 5. Adequate liver function (bilirubin \< 1.95 mg/dL and SGPT or SGOT \< 3 x upper limit of normal \[ULN\], unless considered due to tumor), and renal function (estimated creatinine clearance ≥50 mL/min/1.73 m2). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \< 2.6 mg/dL and creatinine \< 3 mg/dL. 6. Provision of written informed consent. 7. Patients in first remission are eligible. 8. Patients with refractory-relapsed ALL, Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified with marrow involvementBof any age are eligible. Exclusion Criteria: 1. Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma. 2. Patient with active heart disease (NYHA class \> 3 as assessed by history and physical examination). 3. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \< 40% are excluded. 4. Patients with active hepatitis are excluded. 5. Pregnant or breast-feeding women are excluded.

Treatments Being Tested

BIOLOGICAL

Blinatumomab

Given CIVI

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT and IV

DRUG

Dexamethasone

Given IV or PO

BIOLOGICAL

Inotuzumab Ozogamicin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, IV, and PO

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Vincristine

Given IV

Locations (1)

M D Anderson Cancer Center
Houston, Texas, United States