Drug combo aims to boost remission in rare lymphoma

NCT ID NCT04416451

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This phase 2 trial investigates whether combining rituximab (an antibody therapy) with venetoclax (a targeted pill) can effectively treat marginal zone lymphoma in people who have not yet received any treatment for their cancer. The study enrolls adults with measurable disease and tracks how many achieve a complete response. The goal is to see if this drug pair can become a new standard first-line option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rituximab and venetoclax
What this could lead to
If effective, this combination could offer a new first-line treatment option for marginal zone lymphoma, potentially improving how many patients achieve complete remission.
What could go wrong
This is a small, early-phase study (only 6 participants) with no control group, so results may not be generalizable. Side effects from the drug combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

6 people

The number who actually took part.

Started

May 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age greater than or equal to 18 years * Histologically confirmed Marginal Zone Lymphoma * Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm or spleen \>13 cm. °Patients with intestinal MALT lymphoma must have disease that is detectable by EGD or colonoscopy with biopsy * Patients with gastric MALT lymphoma must be h. pylori negative °Patients who are h. pylori positive are allowed if they have failed a trial of h.pylori eradication * Patients with gastric MALT lymphoma who are h. pylori negative or who have relapsed/refractory disease after h. pylori eradication must be ineligible for, have refused or failed gastric radiation therapy * ECOG performance status ≤ 1 * Life expectancy of greater than 2 years * Patients must have normal organ function as defined below: * Platelet count ≥ 50,000 cells/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count ≥ 1000 cells/mcL. If there is documented bone marrow involvement, ANC must be \>/= 500 cells/mcL * Total bilirubin \< 1.5 x upper normal institutional limits. In patients with Gilbert's disease or documented liver involvement, total bilirubin up to 3x ULN will be allowed * AST(SGOT)/ALT(SGPT) \<3 x institutional upper limit of normal unless elevation is caused by liver involvement with MZL * AST(SGOT)/ALT(SGPT) \<3 x institutional upper limit of normal unless elevation is caused by liver involvement with MZL °OR Creatinine clearance \>60 mL/min for patients with creatinine levels above institutional normal (by Cockcroft-Gault estimate or 12-24h creatinine clearance measurements). * Ability to understand and the willingness to sign a written informed consent document. * Able to swallow pills * HIV-positive patients on combination antiretroviral therapy are eligible if their HIV is under adequate control with an antiretroviral regimen that has been stable for \> 4 weeks, as long as the CD4 count is \> 300. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. * Patients with Hepatitis B surface antibody serum positivity due to prior immunization, as well as those with Hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible. Exclusion Criteria: * Patients who have had prior systemic therapy, including rituximab * Patients who have had prior radiation therapy, with the following exception: °Palliative radiotherapy RT is allowed but must be completed at least 1 week prior to treatment on this study, and prior baseline imaging studies or biopsies. Patients must meet criteria for measurable/assessable disease as outlined above after completion of RT * Prior treatment with ibrutinib or other BTK inhibitor * Patients with h. pylori-associated gastric MALT or stage I/II MZL will be excluded unless they are deemed to be unfit for radiation therapy with curative intent. * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements °Patients with Hep B core ab positivity are allowed provided Hep B PCR is undetectable * Lactating or pregnant women * Participants unwilling to adhere to institutional guidelines for highly effective contraception for 12 months after the last dose of rituximab * Patients who received moderate or strong CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of venetoclax. * Patients who received moderate or strong CYP3A inducers (such as rifampin, carbamazepine, phenytoin, St. John's Wort) within 7 days prior to the first dose of venetoclax.

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Conditions

The condition(s) this trial relates to.

Lymphoma, B-Cell, Marginal Zone marginal zone lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • City of Hope Cancer Center (Data collection only)

    Duarte, California, 91010, United States

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (All protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (All Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (All protocol activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Rockville Centre (All Protocol Activities)

    Rockville Centre, New York, 11570, United States

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604, United States

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