New combo therapy aims to keep lymphoma at bay after transplant
NCT ID NCT04491370
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a drug called polatuzumab vedotin can safely help control lymphoma after a stem cell transplant. About 20 people with B-cell or Hodgkin lymphoma who have had a relapse or not responded to prior treatment will receive the drug if their disease is stable after transplant. The goal is to see if this approach can prevent the cancer from coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- polatuzumab vedotin
- What this could lead to
- If this works, it could offer a way to keep lymphoma from coming back after a stem cell transplant, potentially improving long-term control of the disease.
- What could go wrong
- This is an early-phase trial with only 20 participants, so results may not apply to everyone. The drug can cause serious side effects, and it's unclear if it will improve outcomes compared to standard care.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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12 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Diagnosis B-cell NHL: Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Follicular Lymphoma, Richter syndrome, and CD20+ Hodgkin Lymphoma. * Disease Status Primary Induction Failure, 1st, 2nd or 3rd relapse/progression having attained a CR, PR, or stable disease post reinduction therapy. * Performance Level Patients must have a performance status ≥ 50%. Use Karnofsky for patients \> 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score. * Life Expectancy Patients must have a life expectancy of \> 6 weeks. * Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. 1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea). 2. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. * Organ Function Requirements Adequate Renal Function Defined As: * Creatinine clearance or radioisotope GFR \> 60 mL/min/1.73 m2 or * A serum creatinine based on age/gender as follows: Age Maximum Serum Creatinine (mg/dL) Male Female * 12 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4 * 16 years 1.7 1.4 * Adequate Liver Function Defined As: * Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age, and * SGOT (AST) or SGPT (ALT) \< 3 x upper limit of normal (ULN) for age for presumed hepatic leukemia or lymphoma. * Adequate Cardiac Function Defined As: * Shortening fraction of \> 27% by echocardiogram, or * Ejection fraction of \> 50% by radionuclide angiogram. * Adequate Pulmonary Function Defined As: • Normal respiratory rate for age and a pulse oximetry \> 94% on room air unless due to underlying malignancy. * Peripheral Blood Stem Cell Collection • Patients have a target of 5.0 x 106 CD34 (minimum of 2.5 x 106 CD34) PBSC collected and cryopreserved prior to start of myeloablative conditioning * All patients and/or their parents or legal guardians must sign a written informed consent. Exclusion Criteria: * Patient may not have had a prior stem cell transplant * Patients must not have active CNS lymphoma * Other concurrent investigational agents for treatment of B-cell lymphoma * Pregnancy and/or active Breast Feeding * Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation. * Patient must not have an uncontrolled infection. * Patient must not have ≥ Grade 3 neuropathy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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New York Medical Center
RECRUITINGValhalla, New York, 10595, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Drug attack on Hard-to-Treat lymphomas
- PET scans guide Nivolumab-Chemo combo in relapsed hodgkin lymphoma
- Patient's own t cells engineered to hunt lymphoma in early trial
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Triple drug combo targets mantle cell lymphoma