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New treatment option for B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Official title Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT01371630
What this study is testing
What is Blinatumomab?
Blinatumomab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for b acute lymphoblastic leukemia with t(9;22)(q34.1;q11.2); bcr-abl1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior...
- Patients unfit ≥ 18 - \< 60 years of age with previously untreated ALL pre- B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL (includes...
- 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%)
You likely can't join if
- Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma.
- Patient with active heart disease (NYHA class \> 3 as assessed by history and physical examination).
- Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \< 40% are excluded.
- Patients with active hepatitis are excluded.
- Pregnant or breast-feeding women are excluded.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma.
- Patient with active heart disease (NYHA class \> 3 as assessed by history and physical examination).
- Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \< 40% are excluded.
- Patients with active hepatitis are excluded.
- Pregnant or breast-feeding women are excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.