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Taking people in United StatesPhase 1/2

Tests inotuzumab ozogamicin with chemotherapy for acute lymphoblastic leukemia

Tests inotuzumab ozogamicin with low-intensity chemotherapy in adults with acute lymphoblastic leukemia.

Key facts

Who runs it
M.D. Anderson Cancer Center
Where
Houston, United StatesSee the site
Trial code
Registry title
Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
Status
Recruiting
Phase
Phase 1/2
People taking part
276 people, planned
Started
26 Aug 2011
Expected to end
25 Dec 2027
Type of study
Interventional, 3 groups
Treatments tested
  • Blinatumomab
  • Cyclophosphamide
  • Cytarabine
  • Dexamethasone
  • Inotuzumab Ozogamicin
  • Laboratory Biomarker Analysis
  • Mercaptopurine
  • Methotrexate
  • Prednisone
  • Rituximab
  • Vincristine
Record updated
15 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with B-cell acute lymphoblastic leukemia or related B-cell lymphomas. It includes people not treated before, or whose disease came back or did not respond. Some groups are older adults or adults not fit for intensive chemotherapy.

Age
18 years or older. Some groups: 60 years or older, or 18 to under 60 years if unfit for intensive chemotherapy.
Sex
Women and men can join.
Disease stage
Previously untreated pre-B ALL (Philadelphia chromosome negative or positive), including first remission. Also relapsed or refractory ALL, Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, and high-grade B-cell lymphomas with marrow involvement.
Earlier treatment
For untreated ALL in people 60 or older, minimal earlier treatment is allowed: less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents. For adults 18 to under 60, one or two cycles of chemotherapy before are allowed.
Biomarker or test result
Philadelphia chromosome negative or positive ALL. For lymphomas: MYC and BCL2 and/or BCL6 rearrangements, or an 11q aberration, depending on the type.

Main reasons for not taking part

  • Newly diagnosed Burkitt's leukemia or lymphoma, T-cell ALL, or lymphoblastic lymphoma
  • Active heart disease (NYHA class above 3)
  • Cardiac ejection fraction below 40%
  • Active hepatitis
  • Pregnant or breast-feeding women

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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
  • 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:; ECOG performance status ≥ 2; Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina); Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%); Creatinine clearance < 45 mL/min, and; Hepatic disorder with total bilirubin > 1.5 x upper limit of normal; <!-- -->; If they achieved CR, they are assessable only for event-free and overall survival, or; If they failed to achieve CR, they are assessable for CR, event-free, and overall survival
  • 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
  • Zubrod performance status 0-3
  • 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
  • Provision of written informed consent
  • Patients in first remission are eligible
  • 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

Who cannot take part

  • Patient with active heart disease (NYHA class > 3 as assessed by history and physical examination)
  • Patients with active hepatitis are excluded
  • Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 40% are excluded
  • Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma
  • Pregnant or breast-feeding women are excluded

Where in United States

  • M D Anderson Cancer CenterHouston, United StatesContact: Elias JabbourTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Arm I (inotuzumab ozogamicin, combination chemotherapy)Treatment being tested

    See Detailed Description Arm I

    Treatment: Blinatumomab, Cyclophosphamide, Cytarabine, Dexamethasone, Inotuzumab Ozogamicin, Laboratory Biomarker Analysis, Mercaptopurine, Methotrexate, Prednisone, Rituximab, and Vincristine

  • Arm II (inotuzumab ozogamicin, combination chemotherapy)Treatment being tested

    See Detailed Description Arm II

    Treatment: Blinatumomab, Cyclophosphamide, Cytarabine, Dexamethasone, Inotuzumab Ozogamicin, Laboratory Biomarker Analysis, Mercaptopurine, Methotrexate, Prednisone, Rituximab, and Vincristine

  • Arm III (inotuzumab ozogamicin, combination chemotherapy)Treatment being tested

    See Detailed Description Arm III

    Treatment: Blinatumomab, Cytarabine, Dexamethasone, Inotuzumab Ozogamicin, Laboratory Biomarker Analysis, Methotrexate, Rituximab, and Vincristine

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)
Plain-language title
Tests inotuzumab ozogamicin with chemotherapy for acute lymphoblastic leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
15 July 2026