Using inotuzumab ozogamicin with chemotherapy to treat 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)
This study is testing if a new drug combined with lighter chemotherapy can help older patients with acute lymphoblastic leukemia who can't handle stronger treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, inotuzumab, blinatumomab, Immunotherapy, rituximab, methotrexate, cyclophosphamide, prednisone |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT01371630 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of inotuzumab ozogamicin combined with low-intensity chemotherapy in treating patients with acute lymphoblastic leukemia (ALL). The study aims to determine the maximum tolerated dose of inotuzumab ozogamicin in elderly patients and evaluate its efficacy in those who are unfit for intensive therapy. The trial includes a dose-escalation phase followed by an efficacy evaluation phase, focusing on both treatment response and side effects. Additionally, it explores genomic alterations that may predict treatment outcomes and compares different methods for assessing minimal residual disease.
Who should consider this trial
Good fit: Ideal candidates include patients aged 60 and older with untreated acute lymphoblastic leukemia or younger patients with significant comorbidities.
Not a fit: Patients with advanced stages of acute lymphoblastic leukemia who have already received extensive prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide a more effective and tolerable option for elderly and unfit patients with acute lymphoblastic leukemia.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Elias Jabbour, MD — M.D. Anderson Cancer Center
- Study coordinator: Elias Jabbour, MD
- Email: ejabbour@mdanderson.org
- Phone: 713-792-7026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.