Diffuse Large B-Cell LymphomaPhase 1/2NCT04517435
ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma
A Phase 1/2 study testing ME-401, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by Deepa Jagadeesh at 1 site in United States.
Trial summary
This study is being done to evaluate if ME-401 can improve the treatment of patients with diffuse large b-celllymphoma (DLBCL). Many patients with DLBCL that are treated with the standard of care (R-CHOP) are cured. However, a little less than half of patients will have their cancer come back despite being treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- ME-401, Rituximab and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to 17 May 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants must have histologically confirmed diffuse large B-cell lymphoma (DLBCL). Participants with previously diagnosed indolent lymphoma (follicular and marginal zone lymphoma but not small lymphocytic lymphoma) who have transformed to DLBCL are eligible only if they have not previously been treated for indolent lymphoma.
- --If participants received single rituximab (maximum 4-8 doses with no maintenance) for their low grade lymphoma ≥12 months prior to starting study drug are eligible to participate
- Participants must have radiographically measurable disease. At least one bi-dimensionally measurable nodal lesion ≥1.5 cm in its longest diameter by CT scan or MRI, as defined by the Lugano Classification
- Patients participating in the phase II part are allowed to receive brief (<15 days) treatment with glucocorticoids (max dose of prednisone 40 mg) and/or 1 cycle of chemotherapy such as R-CHOP [or some component(s) thereof] for the diagnosis of B-cell lymphoma provided they had all necessary staging tests performed prior to R-CHOPor steroids including CT and/or PET/CTscans, and bone marrow biopsy. Treatment must occur within 30 days prior to enrollment.
- No prior therapy with PI3K inhibitors or Bruton tyrosine kinase (BTK) inhibitors
- ECOG Performance status ≤2. Performance Status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated.
Show all 25Show fewer
- Participants must have adequate hematologic, hepatic, and renal function as defined below:
- Hemoglobin ≥9.0g/dl unless the anemia is clearly due to DLBCL. If there is BM involvement, this criteria can be waived after discussion with the Sponsor Investigator (per investigators discretion).
- Absolute neutrophil count≥1,000/mcL, unless the neutropenia is clearly due to DLBCL. If there is BM involvement, this criteria can be waived after discussion with the Sponsor Investigator(per investigator discretion)
- Platelet count ≥75,000/mcl unless thrombocytopenia is clearly due to DLBCL. If there is BM involvement, this criteria can be waived after discussion with the Sponsor Investigator(per investigator discretion)
- Bilirubin ≤ 2.0 x ULN unless considered secondary to Gilbert's syndrome, in which case ≤ 3 x ULN
- AST (SGOT) < 2.0 x institutional upper limit of normal
- ALT (SGPT) < 2.0 x institutional upper limit of normal
- Creatinine clearance ≥45 mL/min calculated by Cockcroft-Gault or 24 hour collection
- Adequate cardiac function left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiogram or MUGA (Multi Gated Acquisition Scan).
- QT-interval corrected according to Fridericia's formula (QTcF) ≤450 milliseconds (ms); participants with QTc < 480 msec may be enrolled provided the QTc prolongation is due to a right bundle branch block and stable .
- Negative pregnancy test in women of child-bearing age. The effects of ME-401 on the developing human fetus are unknown. For this reason and because chemotherapeutic agents used in this study are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 2 weeks prior to initiation of treatment, for the duration of study participation and for 3 months after completing treatment. Should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Men must agree to refrain from sperm donation for at least 90 days after the last dose of ME-401
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
- International Prognostic Index must be documented:
- ECOG performance status ≥2
- Age ≥60 years
- extranodal sites ≥ 2
- LDH >upper limit of normal
- Ann Arbor Stage III or IV
- Is there evidence of transformation from indolent lymphoma?
Who cannot join
- Participants receiving any other investigational agents.
- Known CNS involvement by lymphoma. Participants at high risk for secondary CNS involvement but without neurologic symptoms suspected to be due to lymphoma are allowed to be enrolled and receive prophylactic intrathecal chemotherapy including but not limited to methotrexate, cytarabine and glucocorticoids. Participants who are enrolled and subsequently identified to have pathologic confirmation of CNS involvement by lymphoma may be continued on study at the discretion of the principal investigator.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to R-CHOP.
- Participants with ongoing uncontrolled illness including, but not limited to ongoing significantly active infections requiring intravenous antibiotics, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction.
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia.
- Ongoing drug-induced pneumonitis.
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- History of clinically significant gastrointestinal (GI) conditions, particularly:
- Known GI condition that would interfere with swallowing or the oral absorption or tolerance of study drug
- Pre-existing malabsorption syndrome or other clinical situation that would
- Active congestive heart failure (New York Heart Association [NYHA] Class>2), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within six months prior to enrollment.
- Participants who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody PLUS have detectable viral load on hepatitis B polymerase chain reaction (PCR) assay (participants with a negative PCR assay are permitted with appropriate anti-viral prophylaxis)
- Positive hepatitis C virus antibody (HCV Ab) participants with positive hepatitis C antibody are eligible if they are negative for hepatitis C virus by PCR
- HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ME-401
- Pregnant or breastfeeding women are excluded from this study because there are no studies assessing the reproductive and developmental toxicity or excretion into breast milk of ME-401. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with ME-401, breastfeeding should be discontinued if the mother is treated with ME-401. These potential risks may also apply to other drugs used in this study.
- Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin, or low-risk prostate cancer after curative therapy.
- Participants who have had major surgical procedures or significant traumatic injury within 28 days prior to study treatment.
- Psychiatric illness/social situations that would interfere with study compliance
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: An Open-Label, Phase I/II Study of ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma
This study is being done to evaluate if ME-401 can improve the treatment of patients with diffuse large b-celllymphoma (DLBCL). Many patients with DLBCL that are treated with the standard of care (R-CHOP) are cured. However, a little less than half of patients will have their cancer come back despite being treated. Once DLBCL comes back, it is much harder to treat and treatment is much more aggressive. This study will combine ME-401 with R-CHOP. There are 2 parts to this study: part1 referred to as phase I and part 2 referred to as phase 2. The goal of the phase I study is to find the safest dose to give patients in combination with R-CHOP. The goal of the phase 2 study is to use the safest dose (found in phase 1) in combination with R-CHOP to see if it decreases the rate of cancer coming back after it is treated.
Read the detailed description
This study is a multi-institution, open-label, phase I/II study designed to evaluate the safety and efficacy of R-CHOP + ME-401 for participants with newly diagnosed DLBCL.
Objectives for the phase I portion of this study are as follows:
Primary objectives:
- To determine the recommended phase 2 dose (RP2D) of ME-401in combination with R-CHOP for participants with newly diagnosed DLBCL.
- To describe tolerability of ME-401 in combination with R-CHOP for participants with newly diagnosed DLBCL.
Objectives for the phase II portion of this study are as follows:
- To estimate the clinical activity of ME-401 in combination with R-CHOP in participants with newly diagnosed DLBCL, as measured by 1 year PFS rate
- To estimate the response rates (complete and partial remission),duration of response (DOR), time to progression (TTP), and overall survival (OS) with ME-401 plus R-CHOP.
- To characterize treatment-related AEs in participants treated with ME-401 plus R-CHOP.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- ME-401, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
- 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.
ME-401Drug
Also called PWT-143
ME-401 (60 mg) will be given by mouth every 21 days for 6 cycles on days 1-4 (dose level 1) OR days 1-7 (dose level 2) of a 21 day cycle. Dose escalation will be performed in a standard 3+3 design
RituximabDrug
Also called Rituxan, Mabthera
375 mg/m2 IV/subcutaneous rituximab day 1 of 21-day cycle.
First dose of rituximab will be given IV and subsequent doses can be either IV or SQ based on institutional guidelines.
CyclophosphamideDrug
Also called Cytoxan
750 mg/m2 IV Cyclophosphamide day 1 of 21-day cycle
DoxorubicinDrug
Also called Doxorubicin Hydrochloride
50 mg/m2 IV Doxorubicin day 1 of 21-day cycle
VincristineDrug
Also called OncovinTM
1.4 mg/m2 (max 2 mg) IV Vincristine
PrednisoneDrug
100mg PO Prednisone Days 1-5 of 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| ME-401 + R-CHOP | Experimental | Participants will receive ME-401 dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose R-CHOP. ME-401 (60 mg) will be given on days 1-4 (dose level 1) OR days 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles. Receives: Drug: ME-401; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Number of Clinically Significant Non-hematologic Grade 3 or 4 Treatment-related AEs or Hematologic Grade 3 or 4 Treatment Related AEs
Dose limiting toxicity (DLT) as defined by non-hematologic clinically significant grade 3 or 4 treatment-related AEs or hematologic grade 3 or 4 treatment related AEs that are clinically significant during the first cycle, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Measured: Up to 24 months after treatment
Phase II: Progression Free Survival (PFS) Assessed by Lugano Criteria
PFS, as defined as time from study treatment initiation to documented disease progression per Lugano Criteria, or death from any cause, whichever occurs first.
Measured: 24 months (2 years)
Secondary outcomes (9)
Phase I: Number of Treatment-related AEs
Number of treatment-related AEs in Phase I.
Participants will be followed for toxicity for 30 days after treatment has been discontinued or until death, whichever occurs first. The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause with a cut off of 24 months after completion of therapy.
Measured: Up to 24 months after treatment
Phase II: Number of Treatment-related AEs
Number of treatment-related AEs in Phase II
Participants will be followed for toxicity for 30 days after treatment has been discontinued or until death, whichever occurs first. The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause with a cut off of 24 months after completion of therapy.
Measured: Up to 24 months after treatment
Phase II: Number of Days Treatment is Delayed
Number of days treatment is delayed
Measured: Up to 24 months after treatment
Phase II: Overall Response (OR) Assessed by Lugano Criteria
OR assessed by Lugano criteria. OR is defined as achieving either CR or PR at any stage from time of commencement of protocol treatment to time of treatment cessation for whatever reason
Measured: 24 months (2 years)
Complete Response (CR) Assessed by Lugano Criteria
CR assessed by Lugano criteria
Measured: 24 months (2 years)
Partial Response (PR) Assessed by Lugano Criteria
PR assessed by Lugano criteria
Measured: 24 months (2 years)
Phase II: Duration of Response (DoR)
DoR defined as the time from documented response (CR or PR) to the time of confirmed disease progression or death due to any cause, whichever occurs first
Measured: 24 months (2 years)
Phase II: Overall Survival (OS)
OS defined as the time from first dose of study treatment to death from any cause
Measured: 24 months (2 years)
Phase II: Time to Treatment Failure
Time to Treatment Failure defined as the time from study entry to any treatment failure.
Measured: 24 months (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start28 Apr 2021
- Primary completion17 May 2023
- Study completion17 May 2023
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deepa Jagadeesh
- Sponsor type
- University, hospital or other
- Collaborators
- Case Comprehensive Cancer Center
- Responsible party
- Sponsor-investigator, Deepa Jagadeesh, Case Comprehensive Cancer Center
- Investigators
- Deepa Jagadeesh, MD, MPH, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517435
- Sponsor's protocol ID
- CASE1420
- Status last verified
- Jan 2025
- First submitted
- 14 Aug 2020
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data in order to protect the confidentiality of the subjects who enroll on the study
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase I/II Study of ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04517435
- Acronym / sponsor ID
- CASE1420
- Conditions
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Deepa JagadeeshUniversity, hospital or other
- Collaborators
- Case Comprehensive Cancer Center
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Posted 7 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to evaluate if ME-401 can improve the treatment of patients with diffuse large b-celllymphoma (DLBCL). Many patients with DLBCL that are treated with the standard of care (R-CHOP) are cured. However, a little less than half of patients will have their cancer come back despite being treated. Once DLBCL comes back, it is much harder to treat and treatment is much more aggressive. This study will combine ME-401 with R-CHOP. There are 2 parts to this study: part1 referred to as phase I and part 2 referred to as phase 2. The goal of the phase I study is to find the safest dose to give patients in combination with R-CHOP. The goal of the phase 2 study is to use the safest dose (found in phase 1) in combination with R-CHOP to see if it decreases the rate of cancer coming back after it is treated.
Detailed description
This study is a multi-institution, open-label, phase I/II study designed to evaluate the safety and efficacy of R-CHOP + ME-401 for participants with newly diagnosed DLBCL.
Objectives for the phase I portion of this study are as follows:
Primary objectives:
- To determine the recommended phase 2 dose (RP2D) of ME-401in combination with R-CHOP for participants with newly diagnosed DLBCL.
- To describe tolerability of ME-401 in combination with R-CHOP for participants with newly diagnosed DLBCL.
Objectives for the phase II portion of this study are as follows:
- To estimate the clinical activity of ME-401 in combination with R-CHOP in participants with newly diagnosed DLBCL, as measured by 1 year PFS rate
- To estimate the response rates (complete and partial remission),duration of response (DOR), time to progression (TTP), and overall survival (OS) with ME-401 plus R-CHOP.
- To characterize treatment-related AEs in participants treated with ME-401 plus R-CHOP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ME-401 + R-CHOP | Experimental | Drug: ME-401, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: PrednisoneParticipants will receive ME-401 dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose R-CHOP. ME-401 (60 mg) will be given on days 1-4 (dose level 1) OR days 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Participants must have histologically confirmed diffuse large B-cell lymphoma (DLBCL). Participants with previously diagnosed indolent lymphoma (follicular and marginal zone lymphoma but not small lymphocytic lymphoma) who have transformed to DLBCL are eligible only if they have not previously been treated for indolent lymphoma.
- --If participants received single rituximab (maximum 4-8 doses with no maintenance) for their low grade lymphoma ≥12 months prior to starting study drug are eligible to participate
- Participants must have radiographically measurable disease. At least one bi-dimensionally measurable nodal lesion ≥1.5 cm in its longest diameter by CT scan or MRI, as defined by the Lugano Classification
- Patients participating in the phase II part are allowed to receive brief (<15 days) treatment with glucocorticoids (max dose of prednisone 40 mg) and/or 1 cycle of chemotherapy such as R-CHOP [or some component(s) thereof] for the diagnosis of B-cell lymphoma provided they had all necessary staging tests performed prior to R-CHOPor steroids including CT and/or PET/CTscans, and bone marrow biopsy. Treatment must occur within 30 days prior to enrollment.
- No prior therapy with PI3K inhibitors or Bruton tyrosine kinase (BTK) inhibitors
Key exclusion criteria (17 listed)
- Participants receiving any other investigational agents.
- Known CNS involvement by lymphoma. Participants at high risk for secondary CNS involvement but without neurologic symptoms suspected to be due to lymphoma are allowed to be enrolled and receive prophylactic intrathecal chemotherapy including but not limited to methotrexate, cytarabine and glucocorticoids. Participants who are enrolled and subsequently identified to have pathologic confirmation of CNS involvement by lymphoma may be continued on study at the discretion of the principal investigator.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to R-CHOP.
- Participants with ongoing uncontrolled illness including, but not limited to ongoing significantly active infections requiring intravenous antibiotics, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction.
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia.
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 |
|---|---|---|
| ME-401Also: PWT-143ME-401 (60 mg) will be given by mouth every 21 days for 6 cycles on days 1-4 (dose level 1) OR days 1-7 (dose level 2) of a 21 day cycle. Dose escalation will be performed in a standard 3+3 design | Drug | ME-401 + R-CHOP |
| RituximabAlso: Rituxan, Mabthera375 mg/m2 IV/subcutaneous rituximab day 1 of 21-day cycle. First dose of rituximab will be given IV and subsequent doses can be either IV or SQ based on institutional guidelines. | Drug | ME-401 + R-CHOP |
| CyclophosphamideAlso: Cytoxan750 mg/m2 IV Cyclophosphamide day 1 of 21-day cycle | Drug | ME-401 + R-CHOP |
| DoxorubicinAlso: Doxorubicin Hydrochloride50 mg/m2 IV Doxorubicin day 1 of 21-day cycle | Drug | ME-401 + R-CHOP |
| VincristineAlso: OncovinTM1.4 mg/m2 (max 2 mg) IV Vincristine | Drug | ME-401 + R-CHOP |
| Prednisone100mg PO Prednisone Days 1-5 of 21-day cycle | Drug | ME-401 + R-CHOP |
Primary outcome
Phase I: Number of Clinically Significant Non-hematologic Grade 3 or 4 Treatment-related AEs or Hematologic Grade 3 or 4 Treatment Related AEs
Time frame: Up to 24 months after treatment
Dose limiting toxicity (DLT) as defined by non-hematologic clinically significant grade 3 or 4 treatment-related AEs or hematologic grade 3 or 4 treatment related AEs that are clinically significant during the first cycle, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Phase II: Progression Free Survival (PFS) Assessed by Lugano Criteria
Time frame: 24 months (2 years)
PFS, as defined as time from study treatment initiation to documented disease progression per Lugano Criteria, or death from any cause, whichever occurs first.
9 secondary outcomes
Phase I: Number of Treatment-related AEs
Time frame: Up to 24 months after treatment
Phase II: Number of Treatment-related AEs
Time frame: Up to 24 months after treatment
Phase II: Number of Days Treatment is Delayed
Time frame: Up to 24 months after treatment
Phase II: Overall Response (OR) Assessed by Lugano Criteria
Time frame: 24 months (2 years)
Complete Response (CR) Assessed by Lugano Criteria
Time frame: 24 months (2 years)
Partial Response (PR) Assessed by Lugano Criteria
Time frame: 24 months (2 years)
Phase II: Duration of Response (DoR)
Time frame: 24 months (2 years)
Phase II: Overall Survival (OS)
Time frame: 24 months (2 years)
Phase II: Time to Treatment Failure
Time frame: 24 months (2 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data in order to protect the confidentiality of the subjects who enroll on the study
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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. This study is not recruiting at the moment.
Deepa Jagadeesh, MD, MPH principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ME-401, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by Deepa Jagadeesh 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 25 inclusion and 17 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: stopped early, as of the sponsor's last update on 7 Feb 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase I: Number of Clinically Significant Non-hematologic Grade 3 or 4 Treatment-related AEs or Hematologic Grade 3 or 4 Treatment Related AEs (time frame: Up to 24 months after treatment). The study lists 2 primary outcomes in all. 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 7 Feb 2025; AzTrials last refreshed its copy on 2 Nov 2026.