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AzTrials

Diffuse Large B-Cell LymphomaPhase 2NCT04479267

Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma

A Phase 2 study testing Prednisone, Prednisolone and Methylprednisolone in people with Diffuse Large B-Cell Lymphoma and High Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 Rearrangements, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase II trial studies how well polatuzumab vedotin and combination chemotherapy work in treating patients with previously untreated double, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell Lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prednisone, Prednisolone and Methylprednisolone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
21 Aug 2020to 19 Jul 2026
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form (ICF)
  • Previously untreated patients (except for one prior cycle of CHOP+R) with diffuse large B-cell lymphoma (DLBCL) as determined by local pathology. World Health Organization (WHO) histologies will include:
  • Double hit lymphoma (DHL) or triple hit lymphoma (THL) confirmed by fluorescence in situ hybridization (FISH) testing by local pathology (defined as MYC and BCL2 and/or BCL6 rearrangements)
  • High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
  • Double expressor lymphoma (DEL) defined as overexpression of MYC(> or = to 40%) and BCL2 (> or = to 50%) identified by immunohistochemistry (IHC)
  • High grade B-cell lymphoma (HGBL) NOS subtype
Show all 30Show fewer
  • Availability of archival formalin-fixed paraffin-embedded (FFPE) tissue blocks or 15 unstained slides serial sections (3-5 um in thickness) prior to study enrollment. The pathology report must be available for review and a tissue block sent for retrospective central confirmation of diagnosis. If central confirmation is unable to be performed on submitted material, stained slides used for diagnosis and/or additional tumor tissue specimens may also be requested
  • For clarification: Only availability of tumor sample must be verified prior to C1D1 however treatment can commence prior to completion of central review. The adequacy of the tissue will be confirmed if possible (ie. if it will not delay treatment).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Life expectancy of at least 24 weeks
  • At least one bi-dimensionally measurable lesion > 1.5 cm in its longest dimension as measured by CT or magnetic resonance imaging (MRI)
  • Ability and willingness to comply with the study protocol procedures
  • Left ventricular ejection fraction (LVEF) >= 45% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
  • Hemoglobin >= 8.0 g/dL without packed RBC transfusion during 14 days before first treatment (unless due to underlying disease, as established by extensive bone marrow involvement or due to hypersplenism secondary to the involvement of the spleen by DLBCL per the investigator)
  • Absolute neutrophil count (ANC) >= 1,000/uL (unless due to underlying disease, as established by extensive bone marrow involvement or due to hypersplenism secondary to the involvement of the spleen by DLBCL per the investigator)
  • Platelet count >= 75,000/uL (unless due to underlying disease, as established by extensive bone marrow involvement or due to hypersplenism secondary to the involvement of the spleen by DLBCL per the investigator)
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 12 months after the last dose of study treatment
  • A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)
  • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices
  • Women must refrain from donating eggs during the same period
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception
  • For women of childbearing potential, a negative serum pregnancy test result within 7 days prior to commencement of dosing. Women who are considered not to be of childbearing potential are not required to have a pregnancy test
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
  • With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 5 months after the last dose of polatuzumab vedotin, 3 months after the last dose of rituximab, and for at least 6 months after the last dose of cyclophosphamide to avoid exposing the embryo for the duration of the pregnancy. Men must refrain from donating sperm during this same period
  • Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Male patients considering preservation of fertility should bank sperm before study treatment
  • CRITERIA FOR TISSUE SUBMISSION:
  • Eligible patients must have available at the study site a representative formalin-fixed, paraffin-embedded tumor specimen that enabled the definitive diagnosis of DLBCL
  • The specimen must contain adequate evaluable tumor cells (>= 20% for excisional biopsy and >= 50% if sample is a core biopsy) to enable relevant biomarker analysis
  • A tissue block (preferred) or 15 serial, freshly cut, unstained slides plus punch biopsy of the tissue block accompanied by an associated pathology report will be requested. Punch biopsy is required only with the slide submission. Cytological or fine-needle aspiration samples are not acceptable
  • If the archival tissue is unavailable or insufficient on the basis of the above criteria, the patient may still be eligible if the patient is willing to provide tissue from a pretreatment core or excisional/incisional biopsy of the tumor. Cytological or fine-needle aspiration samples are not acceptable. The sample should be shipped according to instructions provided in the laboratory manual. Tissue collected on study will not be returned to sites. If needed, additional slides from previously collected samples may be requested. Cases received from each of the participating institutes should be histological confirmed according to the 2016 WHO classification of tumors of hematopoietic and lymphoid neoplasm. The evaluation process by immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH) requires the possession of representative amount of tissues in a paraffin embedded block to be sent to the primary testing institution (Karmanos Cancer Center, Detroit, Michigan). Shipped slides should be placed in proper containers to avoid breakage during shipping. Blocks of paraffin embedded tissue or slides should be sent with a tracking number the address. In addition, the participation institution should call the laboratory at 313-576-8351 (Julie Boerner) for any sample that they ship and provide tracking number

Who cannot join

  • Contraindication to any of the individual components of R-cyclophosphamide, doxorubicin hydrochloride, oxaliplatin, prednisone (CHOP) or any component of PoV, including prior receipt of anthracyclines or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs) (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
  • Contraindication to rituximab or prior administration of an anti CD 20 antibody
  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer prior to cycle 1 day 1 with the following exceptions:
  • One prior treatment cycle of CHOP+R is allowed. Patients who received one prior R-CHOP will receive 6 cycles of R-CHP plus Polatuzumab Vedotin per protocol treatment.
  • Glucocorticoid treatment required for lymphoma symptom control prior to the start of study treatment, prednisone 100 mg or equivalent can be given for a maximum of 13 days as a prephase treatment, with all tumor assessments completed prior to starting prednisone
  • One dose of prophylactic intrathecal chemotherapy with methotrexate
Show all 37Show fewer
  • Grade 3b follicular lymphoma
  • Primary mediastinal (thymic) large B-cell lymphoma
  • Burkitt lymphoma
  • Primary or secondary central nervous system (CNS) lymphoma (primary or secondary involvement), primary effusion DLBCL, and primary cutaneous DLBCL
  • Current grade 2 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) 5.0
  • History of other malignancy that could affect compliance with the protocol or interpretation of results. Exceptions include, but are not limited to:
  • Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or ductal carcinoma in situ of the breast at any time prior to the study are eligible
  • A patient with any other malignancy that has been treated with surgery alone with curative intent and the malignancy has been in remission without treatment for >= 3 years prior to enrollment is eligible
  • Patients with low-grade, early-stage prostate cancer with no requirement for therapy at any time prior to study are eligible
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
  • History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to cycle 1 day 1
  • Patients with clinical suspicion of active or latent tuberculosis (to be confirmed by a positive interferon gamma release assay)
  • Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology)
  • Patients with occult or prior HBV infection (defined as negative HBsAg and positive hepatitis B core antibody [HBcAb]) may be included if HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) is undetectable, provided that they are willing to undergo DNA testing on day 1 of every cycle and monthly for at least 12 months after the last cycle of study treatment. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible
  • Positive test results for hepatitis C virus (HCV) antibody
  • Patients who are positive for HCV antibody are eligible only if PCR is negative for HCV ribonucleic acid (RNA)
  • Known history of human immunodeficiency virus (HIV) seropositive status
  • For patients with unknown HIV status, HIV testing will be performed at screening
  • Vaccination with a live vaccine within 28 days prior to treatment
  • Recent major surgery (within 6 weeks before the start of cycle 1 day 1) other than for diagnosis
  • Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of study treatment
  • Patients with a history of progressive multifocal leukoencephalopathy
  • Creatinine > 1.5 x ULN or a measured creatinine clearance < 40 mL/min (unless abnormal laboratory values are due to underlying lymphoma per the investigator)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN (unless abnormal laboratory values are due to underlying lymphoma per the investigator)
  • Total bilirubin >= 1.5 x ULN (unless abnormal laboratory values are due to underlying lymphoma per the investigator)
  • Patients with documented Gilbert disease may be enrolled if total bilirubin is =< 3 x ULN
  • International normalized ratio (INR) or prothrombin time (PT) > 1.5 x ULN in the absence of therapeutic anticoagulation (unless abnormal laboratory values are due to underlying lymphoma per the investigator)
  • Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) > 1.5 x ULN in the absence of a lupus anticoagulant (unless abnormal laboratory values are due to underlying lymphoma per the investigator)
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • The use of Evushield or other post-exposure anti-viral medications against COVID19 does not affect study eligibility

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: A Phase II Study Evaluating Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Double and Triple Hit Lymphoma, Double Expressor Lymphoma and High-Grade B Cell Lymphoma

This phase II trial studies how well polatuzumab vedotin and combination chemotherapy work in treating patients with previously untreated double, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell Lymphoma. Polatuzumab vedotin is a monoclonal antibody that works by binding with cancer cells and releasing another chemotherapy drug, called monomethyl auristatin E, into the cell causing the cancer cells to die or stop growing. Chemotherapy drugs, such as rituximab, cyclophosphamide, doxorubicin, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving polatuzumab vedotin with combination chemotherapy may work better in treating patients with double or triple hit lymphoma compared to combination chemotherapy alone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the rate of complete remission (CR) with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin hydrochloride, and prednisone (R-CHP) in patients with newly diagnosed previously untreated double, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell Lymphoma. as measured by positron emission tomography (PET)-defined CR rate using the modified Lugano response criteria at the time of primary response assessment (6-8 weeks after cycle 6 day 1 or last dose of study medication).

PRIMARY OBJECTIVE:

  1. To determine the rate of complete remission (CR) with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin hydrochloride, and prednisone (R-CHP) in patients with newly diagnosed previously untreated double, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell Lymphoma. as measured by positron emission tomography (PET)-defined CR rate using the modified Lugano response criteria at the time of primary response assessment (6-8 weeks after cycle 6 day 1 or last dose of study medication).

SECONDARY SAFETY OBJECTIVE:

  1. To evaluate the safety and tolerability of the combination of polatuzumab vedotin (PoV) plus R-CHP as defined by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

SECONDARY EFFICACY OBJECTIVES:

  1. To assess the progression free survival (PFS) with PoV plus R-CHP in the above-mentioned patient population.

II. To assess the overall survival (OS) with PoV plus R-CHP in the above-mentioned patient population.

III. To assess the overall response rate (ORR; complete response [CR] or partial response [PR]) at the time of primary response assessment, based on modified Lugano PET-computed tomography (CT) criteria, as determined by the investigator.

IV. To assess the duration of response (DOR) to PoV plus R-CHP based on PET-CT, as determined by the investigators in the above-mentioned patient population.

EXPLORATORY OBJECTIVES:

  1. To explore the relationship between CD79b expression and response to treatment with PoV plus R-CHP.

II. To explore the relationship between MYC expression and response to treatment with PoV plus R-CHP.

III. To explore polatuzumab vedotin treatment on Myc protein expression.

OUTLINE:

Patients receive prednisone orally (PO), prednisolone intravenously (IV), or methylprednisolone IV on days 1-5. Patients also receive rituximab IV, polatuzumab vedotin IV over 30-90 minutes, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 12 months.

Being tested
Prednisone, Prednisolone, Methylprednisolone, Rituximab, Polatuzumab Vedotin
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione, 53-03-2, Adasone, Cortancyl, Dacortin, , Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome

    Given PO

  • PrednisoloneDrug

    Also called (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione, .delta.1-Hydrocortisone, 1,2-Dehydrohydrocortisone, 50-24-8, 9120, Adnisolone, Aprednislon, Capsoid, Cortalone, Cortisolone

    Given IV

  • MethylprednisoloneDrug

    Also called (6alpha,11beta)-11,17,21-Trihydroxy-6-methylpregna-1,4-diene-3,20-dione, 6Alpha-Methylprednisolone, Adlone, Caberdelta M, DepMedalone, Depo Moderin, Depo-Nisolone, Duralone, Emmetipi, Esametone

    Given IV

  • RituximabBiological

    Also called 174722-31-7, 687451, ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8

    Given IV

  • Polatuzumab VedotinDrug

    Also called 1313206-42-6, ADC DCDS4501A, Antibody-Drug Conjugate DCDS4501A, DCDS4501A, FCU 2711, POLATUZUMAB VEDOTIN, polatuzumab vedotin-piiq, Polivy, RG7596, Ro 5541077-000

    Given IV

  • CyclophosphamideDrug

    Also called 1-bis(2-chloroethyl)-amino-1-oxo-2-aza-5-oxaphosphoridin monohydrate, 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

    Given IV

  • Doxorubicin HydrochlorideDrug

    Also called 14-Hydroxydaunorubicin Hydrochloride, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-

    Given IV

Study groups in NCT04479267
Study groupRoleWhat they receive
Treatment (polatuzumab vedotin, R-CHP)ExperimentalPatients receive prednisone PO, prednisolone IV, or methylprednisolone IV on days 1-5. Patients also receive rituximab IV, polatuzumab vedotin IV over 30-90 minutes, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Prednisone; Drug: Prednisolone; Drug: Methylprednisolone; Biological: Rituximab; Drug: Polatuzumab Vedotin; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of complete remission

    Will be assessed by modified Lugano response criteria for malignant lymphoma. The complete remission rate will be summarized by a binomial response rate and its associated 2-sided 80% confidence interval (CI) using Pearson-Klopper method. The primary efficacy analysis will be also performed based on all response evaluable subjects as a sensitivity analysis.

    Measured: Up to 6-8 weeks after cycle 6 day 1 (cycles = 21 days) or last dose of study medication

Secondary outcomes (4)

  1. Incidence of adverse events

    Safety will be assessed through summaries of adverse events, summaries of changes from screening assessments in laboratory test results, electrocardiograms, and changes in vital signs. All adverse events occurring on or after first study treatment will be summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute (NCI) Common Terminology Criteria Adverse Events version (v) 4.03 toxicity grade. All serious adverse events will be listed separately and summarized. Deaths reported during the study treatment period and those reported during follow-up after treatment discontinuation will be listed. Relevant laboratory and vital sign (temperature, heart rate, respiratory rate, pulse oximetry, and blood pressure) data will be displayed by time, with NCI Common Terminology Criteria for Adverse Events v5.0. Grade 3 and 4 values identified where appropriate.

    Measured: Up to 30 days after last dose of study treatment

  2. Progression-free survival (PFS)

    The distribution of PFS will be graphically summarized using the Kaplan-Meier (KM) curve and the median PFS and its associated 2-sided CI will be estimated using the KM estimator. The median follow-up time and its 2-sided CI will be estimated using the reverse KM estimator.

    Measured: From the start date of the treatment until the date of progression or death from any cause, whichever occurs first, assessed up to 12 months

  3. Overall response rate (ORR)

    Will be defined as complete response (CR) or partial response (PR) at primary response assessment based on positron emission tomography/computed tomography as determined by the investigator and assessed using modified Lugano response criteria. CR and PR will be summarized using frequency and percentage. The ORR will be summarized by a binomial response rate and its associated 2-sided CI using Pearson-Klopper method.

    Measured: Up to 12 months

  4. Duration of response (DOR)

    The distribution of DOR will be graphically summarized using the KM curve and the median PFS and its associated 2-sided CI will be estimated using the KM estimator.

    Measured: From the date of CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is documented among all treated subjects who had a confirmed CR or PR, assessed up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start21 Aug 2020
  3. Primary completion19 Jun 2025
  4. Study completion19 Jul 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04479267
Sponsor's protocol ID
2019-135
Other IDs
P30CA022453
Status last verified
Sep 2025
First submitted
16 Jul 2020
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prednisone, Prednisolone and Methylprednisolone in people with Diffuse Large B-Cell Lymphoma and High Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 Rearrangements, run by Barbara Ann Karmanos Cancer Institute 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 30 inclusion and 37 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of complete remission (time frame: Up to 6-8 weeks after cycle 6 day 1 (cycles = 21 days) or last dose of study medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04479267.

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 29 Sep 2025.

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