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New treatment option for T-cell Acute Lymphoblastic Leukemia
Official title Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma
ClinicalTrials.gov ID: NCT07513129
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for t-cell acute lymphoblastic leukemia.
Also referred to as Venclexta.
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 is an open-label, single institution, Phase 1 study of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult participants with relapsed or refractory T-ALL or T-LBL
- 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 12 to 30
You may be able to join if
- Weight must be \> or = to 40 kg
- Patients must have histologically or cytologically confirmed relapsed or refractory T-ALL or TLBL.
- Age ≥ 12 year to ≤ 30 years.
- Lansky ≥60 for patients \<16, Karnofsky ≥60 for patients ≥ 16 years of age. (See Appendix I)
- Baseline ejection fraction must be \> 40% OR Shortening fraction \>20%. Either can be used at the investigator's discretion.
You likely can't join if
- Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at...
- No investigational or commercial anti-cancer agents or therapies other than those described below may be administered with the intent to treat the...
- The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions: i. intrathecal...
- Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
- Patients with severe uncontrolled peripheral neuropathy significantly impairing motor or sensory function.
- Patients with a concurrent second active malignancy under treatment.
See the full eligibility criteria
- Weight must be \> or = to 40 kg
- Patients must have histologically or cytologically confirmed relapsed or refractory T-ALL or TLBL.
- Age ≥ 12 year to ≤ 30 years.
- Lansky ≥60 for patients \<16, Karnofsky ≥60 for patients ≥ 16 years of age. (See Appendix I)
- Baseline ejection fraction must be \> 40% OR Shortening fraction \>20%. Either can be used at the investigator's discretion.
- Adequate hepatic function (direct bilirubin \< 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT \< 5x ULN unless considered due to leukemic...
- Adequate renal function (calculated creatinine clearance ≥ 30 mL/min) unless related to disease as determined by PI.
- In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of...
- Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.
- Patients may have received any of the study agents prior to enrollment in study if not previously provided in study combination.
- For patients with history or evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of active progression.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion.
- Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
- No investigational or commercial anti-cancer agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.
- The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions: i. intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. Previous CNS...
- Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
- Patients with severe uncontrolled peripheral neuropathy significantly impairing motor or sensory function.
- Patients with a concurrent second active malignancy under treatment.
- Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection. Testing is not required for patients without a known or suspected history.
- Female people who are pregnant or breast-feeding.
- Patient has an infection that is both active and uncontrolled.
- History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition venetoclax, dexamethasone, bortezomib, daratumumab.
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, 12 years to 30 years. 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.