T-cell Acute Lymphoblastic LeukemiaPhase 1NCT07513129
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
A Phase 1 study testing Venetoclax, Dexamethasone and Bortezomib in people with T-cell Acute Lymphoblastic Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- T-cell Acute Lymphoblastic Leukemia, Lymphoma
- What is being tested?
- Venetoclax, Dexamethasone and Bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2026to 31 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 involvement, in which case direct bilirubin < 3x ULN or AST and/or ALT < 10x ULN will be considered eligible.
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- 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 the prior therapy (whichever is shorter). Hydroxyurea and/or cytarabine (up to 2 g/m2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI.
- 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 load.
- 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 Functional Classification. To be eligible for this trial, patients should be class 2B or better as determined by PI.
- 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 Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- 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, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- 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.
Who cannot join
- 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:
- intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia.
- Previous CNS evaluation and intrathecal (IT) chemotherapy administered prior to consent can be considered as the Cycle 1 Day 1 IT chemotherapy, provided it was completed within 7 days of C1D1. ii. use of hydroxyurea or cytarabine for patients with rapidly proliferative disease.
- use of steroids for treatment of rapidly proliferative disease. iv. Investigational or commercial agent for supportive care may be used in consultation with the treating physician.
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- 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 subjects 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 the study, or is not in the best interest of the patient to participate.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition venetoclax, dexamethasone, bortezomib, daratumumab.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT MD Anderson
Houston, Texas, 77030
Miriam B Garcia, DO, 713-745-4312, mbgarcia@mdanderson.org
Miriam B Garcia, DO
About this study
Official title: A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And Lymphomas
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
Read the detailed description
Primary Objective:
- To determine the safety and tolerability of the combination of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult patients with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or Lymphoma (LBL).
Secondary Objectives:
- To conduct a preliminary assessment of efficacy in adolescent and young adult patients treated with this combination based on:
- Best overall response (BOR), including complete remission (CR), CR with partial hematological recovery (CRh), CR with incomplete blood count recovery (Cri), morphologic free state (MLFS), partial remission (PR), stable disease (SD), and progressive disease (PD)
- Time-to-event outcomes: overall survival (OS), event-free survival (EFS), and duration of response (DOR)
- Composite remission rate (CRc), defined as CR, CRh, CRi, and MLFS
- Conditions
- T-cell Acute Lymphoblastic Leukemia, Lymphoma
- Being tested
- Venetoclax, Dexamethasone, Bortezomib, Daratumumab
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called Venclexta
Given by mouth
DexamethasoneDrug
Given by mouth or IV
BortezomibDrug
Also called Velcade
Given subcutaneously or IV
DaratumumabDrug
Also called Darzalex, Darzalex Faspro
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD) | Experimental | All participants must complete a screening clinic visit, cycle 1 day 1 (- 28 days), day 1 visits for each new cycle (- 7 days), and an end-of-treatment visit (- 7 days). Receives: Drug: Venetoclax; Drug: Dexamethasone; Drug: Bortezomib; Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start5 Jun 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miriam B Garcia, DOp, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513129
- Sponsor's protocol ID
- 2025-1869
- Other IDs
- NCI-2026-02416
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And Lymphomas
- ClinicalTrials.gov ID
- NCT07513129
- Acronym / sponsor ID
- 2025-1869
- Conditions
- T-cell Acute Lymphoblastic Leukemia, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary Objective:
- To determine the safety and tolerability of the combination of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult patients with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or Lymphoma (LBL).
Secondary Objectives:
- To conduct a preliminary assessment of efficacy in adolescent and young adult patients treated with this combination based on:
- Best overall response (BOR), including complete remission (CR), CR with partial hematological recovery (CRh), CR with incomplete blood count recovery (Cri), morphologic free state (MLFS), partial remission (PR), stable disease (SD), and progressive disease (PD)
- Time-to-event outcomes: overall survival (OS), event-free survival (EFS), and duration of response (DOR)
- Composite remission rate (CRc), defined as CR, CRh, CRi, and MLFS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD) | Experimental | Drug: Venetoclax, Drug: Dexamethasone, Drug: Bortezomib, Drug: DaratumumabAll participants must complete a screening clinic visit, cycle 1 day 1 (- 28 days), day 1 visits for each new cycle (- 7 days), and an end-of-treatment visit (- 7 days). |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (15 listed)
- 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:
- Previous CNS evaluation and intrathecal (IT) chemotherapy administered prior to consent can be considered as the Cycle 1 Day 1 IT chemotherapy, provided it was completed within 7 days of C1D1. ii. use of hydroxyurea or cytarabine for patients with rapidly proliferative disease.
- use of steroids for treatment of rapidly proliferative disease. iv. Investigational or commercial agent for supportive care may be used in consultation with the treating physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxAlso: VenclextaGiven by mouth | Drug | Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD) |
| DexamethasoneGiven by mouth or IV | Drug | Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD) |
| BortezomibAlso: VelcadeGiven subcutaneously or IV | Drug | Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD) |
| DaratumumabAlso: Darzalex, Darzalex FasproGiven by IV | Drug | Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD) |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miriam B Garcia, DOp principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venetoclax, Dexamethasone and Bortezomib in people with T-cell Acute Lymphoblastic Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam B Garcia, DO ((713) 745-4312, mbgarcia@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.