Clinical trial for B Acute Lymphoblastic Leukemia
Official title Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT03150693
What this study is testing
What is Inotuzumab ozogamicin?
An investigational medicine being studied for the treatment of newly diagnosed B‑cell acute lymphoblastic leukemia. It is designed to target CD22 receptors on cancer cells and deliver a chemotherapy agent to kill them.
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
- The study looks at how well inotuzumab ozogamicin works with frontline chemotherapy and what side effects it causes.
- Who it's for
- Young adults newly diagnosed with B‑cell acute lymphoblastic leukemia
- What's involved
- Participants receive the drug inotuzumab ozogamicin together with standard chemotherapy, along with routine medical visits and tests to monitor safety and effectiveness.
- Time commitment
- The trial lasts several months, with regular clinic visits and blood tests as scheduled by the study team.
- Phase 3: a large, late-stage study
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 39
You may be able to join if
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
- Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible.
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic...
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age \>= 18 years and \< 40 years
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2
You likely can't join if
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or...
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=\< 7 days) with corticosteroids or hydroxyurea...
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast...
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and...
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity...
See the full eligibility criteria
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
- Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age \>= 18 years and \< 40 years
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Direct bilirubin =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Calculated (calc.) creatinine clearance \>= 50 mL/min by Cockcroft-Gault
- RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF side effects AND PHASE III ONLY): Completion of remission induction therapy
- RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF side effects AND PHASE III ONLY):Patients with M2 marrow or better are eligible
- Rating: M0, M1; Blast Cells (%): 0-5.0
- Rating: M2; Blast Cells (%): 5.1-25.0
- Rating: M3; Blast Cells (%): \> 25-50
- Rating: M4; Blast Cells (%): \> 50.0
- The term "blast cell" includes any cell that cannot be classified as a more mature normal element, and includes "leukemic cells," pathologic lymphocytes, and stem cells
- RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF side effects AND PHASE III ONLY): Absolute neutrophil count (ANC) \>= 750/mm\^3
- RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF side effects AND PHASE III ONLY): Platelet count \>= 75,000/mm\^3
- RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF side effects AND PHASE III ONLY): Total bilirubin =\< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome
- RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF side effects AND PHASE III ONLY): Aspartate aminotransferase (AST) =\< 8 x upper limit of normal (ULN)
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by...
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=\< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to...
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects
- REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity resulting
The study team makes the final eligibility decision.
Where it is enrolling
- Antioch, California, United States
- Clovis, California, United States
- Costa Mesa, California, United States
- Dublin, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Irvine, California, United States
- Modesto, California, United States
- Oakland, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Richmond, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Jose, California, United States
- San Leandro, California, United States
- San Rafael, California, United States
- Santa Clara, California, United States
- Santa Rosa, California, United States
+ 103 more site(s).
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Antioch, California, United States; Clovis, California, United States; Costa Mesa, California, United States; Dublin, California, United States; Fremont, California, United States; Fresno, California, United States and 117 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.