RecruitingPhase 1/2

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

United States276 participantsStarted 2011-08-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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

Exclusion criteria

What they're measuring

Maximum tolerated dose of inotuzumab ozogamicin based on incidence of dose limiting toxicities (Phase I)

Timeframe: 28 days

Progression free survival (PFS) in frontline elderly acute lymphoblastic leukemia (ALL) (Phase II)

Timeframe: 2 years

Response rate in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II)

Timeframe: Up to 5 years

Survival in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II)

Timeframe: Up to 1 year

Trial details

NCT IDNCT01371630

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-25

Contact for this trial

Elias Jabbour, MD

713-792-7026 ejabbour@mdanderson.org

View on ClinicalTrials.gov More B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 trials