Recruiting
Phase 1
Phase 2

Inotuzumab Ozogamicin & Chemotherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT01371630

Conditions

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Burkitt-Like Lymphoma With 11q Aberration

High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements

High Grade B-Cell Lymphoma, Not Otherwise Specified

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blinatumomab

Cyclophosphamide

Cytarabine

Dexamethasone

Inotuzumab Ozogamicin

Study Details

Brief summary:

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.

Conditions

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Burkitt-Like Lymphoma With 11q Aberration

High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements

High Grade B-Cell Lymphoma, Not Otherwise Specified

Study ID

NCT01371630

Start date

Aug 26, 2011

Status verified date

Jul, 2026

Completion date

Dec 25, 2027

Anticipated

Primary completion date

Dec 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

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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.

Study Design

Enrollment

276 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (inotuzumab ozogamicin, combination chemotherapy)

See Detailed Description Arm I

experimental: Arm II (inotuzumab ozogamicin, combination chemotherapy)

See Detailed Description Arm II

experimental: Arm III (inotuzumab ozogamicin, combination chemotherapy)

See Detailed Description Arm III

Interventions

Blinatumomab

Given CIVI

Cyclophosphamide

Given IV

Cytarabine

Given IT and IV

Dexamethasone

Given IV or PO

Inotuzumab Ozogamicin

Given IV

Laboratory Biomarker Analysis

Correlative studies

Mercaptopurine

Given PO

Methotrexate

Given IT, IV, and PO

Prednisone

Given PO

Rituximab

Given IV

Vincristine

Given IV

Primary outcome measure

  • Maximum tolerated dose of inotuzumab ozogamicin based on incidence of dose limiting toxicities (Phase I) [ Time Frame: 28 days ]
  • Progression free survival (PFS) in frontline elderly acute lymphoblastic leukemia (ALL) (Phase II) [ Time Frame: 2 years ]
  • Response rate in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II) [ Time Frame: Up to 5 years ]
  • Survival in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II) [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Elias Jabbour

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-15.