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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL
ClinicalTrials.gov ID: NCT06863259
What this study is testing
What is Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone?
Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
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 goal of this clinical trial is to learn if the combination of drugs Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) are safe to treat relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL) in pediatric and adult patients. It will also learn if these drugs are well tolerated.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 39
You may be able to join if
- Diagnosis: \- Patients must have relapsed B-ALL \> 5 % bone marrow blasts with or without extramedullary disease.
- At least 20% of leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by flow cytometry of a bone marrow aspirate. In...
- Patients with one of the following:
- 2nd or greater relapse OR first relapse less than 24 months from diagnosis OR first or greater relapse in patients over 18.
- Primary refractory disease: defined as \> 1% bone marrow blasts by flow MRD after at least 2 courses of frontline chemotherapy. Patients who receive...
You likely can't join if
- Patients with any prior history of SOS irrespective of severity.
- Patients with isolated CNS, testicular, or any other isolated extramedullary site of relapse.
- Patients with CNS3 disease at time of enrollment regardless of marrow involvement. Concomitant Medications:
- Investigational drugs: patients who are currently receiving another investigational drug.
- Anti-cancer agents: Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued...
- Anti-GVHD or agents to prevent organ rejection post-transplant. Patients who are receiving cyclosporine, tacrolimus, or other agents to prevent...
See the full eligibility criteria
Who can join
- Diagnosis: \- Patients must have relapsed B-ALL \> 5 % bone marrow blasts with or without extramedullary disease.
- At least 20% of leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by flow cytometry of a bone marrow aspirate. In the case of an inadequate aspirate sample (dry tap) or if bone marrow...
- Patients with one of the following:
- 2nd or greater relapse OR first relapse less than 24 months from diagnosis OR first or greater relapse in patients over 18.
- Primary refractory disease: defined as \> 1% bone marrow blasts by flow MRD after at least 2 courses of frontline chemotherapy. Patients who receive 2 courses of chemotherapy and 1 course of blinatumomab are also...
- Any relapse after HSCT or CAR-T therapy.
- Patients with Ph+ ALL must have had at least two prior therapy attempts and failed all available tyrosine kinase inhibitors. Prior Therapy: \- Cytotoxic chemotherapy:
- At least 14 days must have elapsed from the completion of systemic cytotoxic therapy that is known to be myelosuppressive with the exception of hydroxyurea for cytoreduction OR conventional maintenance chemotherapy...
- Anti-cancer agents that are antibodies
- At least 21 days must have elapsed from infusion of last dose of antibody. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days.
- Radiation therapy
- At least 14 days must have elapsed since local palliative radiotherapy. At least 3 months must have elapsed if patient received cranial or craniospinal radiotherapy, if more than 50% of the pelvis was irradiated, or if...
- Hematopoietic stem cell transplant
- At least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patients must have had no more than one previous HSCT and currently have no evidence of active graft vs...
- Chimeric antigen receptor T-cell therapy
- At least 30 days must have elapsed from the last CAR-T cell infusion. Patients may have previously received CD19 or CD22 directed CAR-T cell therapy but must still have CD22 expression on at least 20% of leukemic blasts.
- Prior Inotuzumab ozogamicin Patients with prior InO exposure must have received no more than 2.1 mg/m2 of prior InO and be at least 90 days from last dose.
- Prior Venetoclax exposure Patients with prior venetoclax exposure are eligible provided they are at least 30 days from last dose. Age: \- Patients must be ≥ 1 year and ≤ 39.99 years of age at enrollment. Performance...
- Adequate Renal Function Defined As:
- An estimated GFR of 50 mL/min/1.73m2 as determined by the Levey formula (see appendix C), cystatin C, or radioisotope determination.
- Adequate Liver Function Defined As:
- Direct bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
- SGPT (ALT) \< 2.5 x the age-appropriate upper limit of normal (ULN) per local lab (unless elevation is related to leukemia involvement).
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
What rules you out
- Patients with any prior history of SOS irrespective of severity.
- Patients with isolated CNS, testicular, or any other isolated extramedullary site of relapse.
- Patients with CNS3 disease at time of enrollment regardless of marrow involvement. Concomitant Medications:
- Investigational drugs: patients who are currently receiving another investigational drug.
- Anti-cancer agents: Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal...
- Anti-GVHD or agents to prevent organ rejection post-transplant. Patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft vs host disease post bone marrow transplant or organ rejection...
- Patients \> 10 kg AND \> 24months may receive azole antifungals (See altered venetoclax dosing provided for patients on azoles). Infection:
- Patients with known HIV, hepatitis B or C infections. Testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient.
- Patients who have an active uncontrolled infection defined as:
- Positive bacterial blood culture within 48 hours of study enrollment.
- Fever above 38.2℃ within 48 hours of study enrollment with documented infection Fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours...
- A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection.
- Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection...
- Active viral or protozoal infection requiring IV treatment.
- Patients known to have one of the following concomitant genetic syndromes: Blood syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachmann-Diamond syndrome, or any other known bone marrow failure...
- There have been no human studies of inotuzumab ozogamicin or venetoclax in pregnant women. Based on safety studies, both agents have the potential to impair human male and female fertility to adversely affect human...
- Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the...
- Men with female partners of childbearing potential should use effective contraception during treatment with inotuzumab ozogamicin and venetoclax and for at least 5 months after the last dose of inotuzumab ozogamicin and...
- Lactating females are not eligible unless they agree not to breastfeed their infants.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 2) with the exception of alopecia.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to venetoclax or inotuzumab ozogamicin.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, 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, 1 year to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, 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.