OncoMatch/Clinical Trials/NCT01371630
Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
Is NCT01371630 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for b acute lymphoblastic leukemia with t(9;22)(q34.1;q11.2); bcr-abl1.
Treatment: Blinatumomab · Cyclophosphamide · Cytarabine · Dexamethasone · Inotuzumab Ozogamicin · Mercaptopurine · Methotrexate · Prednisone · Rituximab · Vincristine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: BCR fusion with ABL1
Philadelphia chromosome (Ph+) positive ALL
Allowed: MYC rearrangement
high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Allowed: BCL2 rearrangement
high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Allowed: BCL6 rearrangement
high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Performance status
ZUBROD 0–3
Zubrod performance status 0-3
Prior therapy
Cannot have received: intensive chemotherapy
Patients age 60 years and older unfit for intensive chemotherapy
Lab requirements
Kidney function
estimated creatinine clearance ≥50 mL/min/1.73 m2; if organ function abnormalities are considered due to tumor, creatinine < 3 mg/dL
Liver function
bilirubin < 1.95 mg/dL and SGPT or SGOT < 3 x upper limit of normal [ULN], unless considered due to tumor; if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is < 2.6 mg/dL
Cardiac function
cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 40% are excluded; severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
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. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina). Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 40% are excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify