Phase 1 Lymphoma Trial, Recruiting NCT07513129 Sponsor: M.D. Anderson Cancer Center Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT07513129
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who weigh at least 40 kg (approximately 88 pounds).
  • People who have been confirmed by laboratory testing to have T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) that has come back or stopped responding to treatment.
  • People aged 12 to 30 years old.
  • People who are able to carry out a reasonable level of daily activity, as measured by standard medical scoring tools — a score of 60 or above on the relevant scale for their age (confirm with trial site).
  • People whose heart is pumping adequately, as shown by specific heart function measurements (confirm with trial site).
  • People whose liver is functioning well enough, based on blood test results, though some exceptions may apply if abnormal results are caused by the underlying disease (confirm with trial site).
  • People whose kidneys are functioning adequately, based on a calculated measure of kidney filtration — unless any reduced function is related to the disease itself (confirm with trial site).
  • People who have waited a sufficient amount of time since their last cancer treatment before starting this trial — generally at least 14 days, or five half-lives of the previous treatment, whichever is shorter. In some cases, certain short-term medications may be permitted beforehand (confirm with trial site).
  • People receiving treatment to prevent or manage cancer in the central nervous system (brain and spinal cord) may still be considered.
  • People who have previously received one or more of the study drugs, as long as they were not previously given in the same combination used in this trial.
  • People with a history of hepatitis B who have an undetectable viral load while on suppressive therapy.
  • People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load.
  • People who have had brain involvement from cancer that has been treated, with follow-up scans showing no signs of the cancer actively growing.
  • People with known heart disease or a history of treatment with medications that can affect the heart, who are assessed as being in a stable enough cardiac condition (Class 2B or better on a standard heart function scale) as determined by the treating doctor.
  • People who are able to use an approved method of contraception for the duration of the trial and for a set period afterwards. This applies to women who could become pregnant and to men. Accepted methods include hormonal contraception, intrauterine devices (IUDs), surgical sterilisation, vasectomy (in a partner), implantable or injectable contraceptives, and condoms with spermicide. Complete abstinence for the full duration of the trial is also accepted. Periodic abstinence, the rhythm method, and withdrawal are not accepted (confirm with trial site for full details).
  • Men enrolled in the trial must agree to use adequate contraception before, during, and for 4 months after completing the trial.

Who may not be able to join:

  • People who have another serious uncontrolled medical condition, significant abnormal lab results, or a psychiatric illness that could put them at unacceptable risk from the study treatment.
  • People who are currently receiving other anti-cancer treatments not specified in this trial's protocol.
  • People who are taking other chemotherapy or anti-leukaemia medications during the trial, except for a small number of permitted exceptions such as certain medications given directly into the spinal fluid, short-term use of specific drugs for rapidly progressing disease, or approved supportive care treatments (confirm with trial site).
  • People who have a severe digestive or metabolic condition that could interfere with the absorption of medications taken by mouth.
  • People with severe, uncontrolled nerve damage (peripheral neuropathy) that significantly affects movement or sensation.
  • People who are currently being treated for a second active cancer.
  • People with a currently active hepatitis B, hepatitis C, or HIV infection. Note: testing is not required unless there is a known or suspected history.
  • People who are pregnant or breastfeeding.
  • People who have an active infection that is not under control.
  • People whose medical history, current condition, or test results might, in the treating doctor's opinion, affect the study results or make full participation unsafe or not in the person's best interest.
  • People who have had allergic reactions to drugs with a similar makeup to venetoclax, dexamethasone, bortezomib, or daratumumab — the medications used in this trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Miriam B Garcia, DOp, UT MD Anderson

Phone: (713) 745-4312

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
5 June 2026
Est. completion
31 December 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and Adverse Events (AEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov