Trial · NCT04933617
Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas
NCT04933617, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2024-07-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas. Trials, record NCT04933617. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04933617
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas
- NCT number
- NCT04933617
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Burkitt Lymphoma, High-grade B-cell Lymphoma, T-cell/Histocyte-rich Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma (DLBCL), Germinal Center B-cell Type (GCB)
- Interventions
- Rituximab, Etoposide, Copanlisib, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, ECHO, EKG, MRI Brain, 18F-FDG - PET, CT Scan, Bone Marrow Aspiration, Bone Marrow Biopsy, Lumbar Puncture (LP)
- First posted
- 2021-06-22
- Last updated
- 2024-07-09
- Results first posted
- 2024-07-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) | 21 days | MTD and RP2D is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is any treatment-emergent, clinically relevant, and related severe (grade ≥ 3) toxicity that is possibly, probably, or definitely related to copanlisib. |
| Secondary | Overall Response Rate (ORR) | Response was assessed after cycles 1, 3 and 6 (each cycle is 21 days), approximately 63 days. | ORR is the best response recorded from the start of the treatment until disease progression/recurrence determined by Kaplan-Meier method and reported along with a 95% confidence interval. Response was assessed by the Revised Response Criteria for Malignant Lymphoma criteria, and the Lugano Classification Response Criteria for Non-Hodgkin Lymphoma (NHL). Complete response (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms. Partial response (PR) is a ≥50% decrease in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses. Progressive disease (PD) is appearance of any new nodal lesion ≥1.6 cm in greatest tumor dimension or ≥1.1 cm in short axis during or after the end of therapy. A participant is considered to have stable disease (SD) when he or she fails to attain the criteria needed for a CR, PR, or Minimal Response (MR) but does not fulfill those for PD. |
| Secondary | Progression-free Survival (PFS) | Time from enrollment to progression or death, approximately 9 months. | PFS is defined as the time from date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first, assessed every 3-6 months The progression free survival will be determined by the Kaplan-Meier method and reported along with a 95% confidence interval. Response was assessed by the Revised Response Criteria for Malignant Lymphoma criteria, and the Lugano Classification Response Criteria for Non-Hodgkin Lymphoma (NHL). Disease relapse is Progressive disease (PD) is appearance of any new nodal lesion ≥1.6 cm in greatest tumor dimension or ≥1.1 cm in short axis during or after the end of therapy or increase by ≥50% from PPD (cross product of the longest transverse diameter and perpendicular diameter) nadir. |
| Secondary | Complete Response Rate | Response was assessed after cycles 1, 3 and 6 (each cycle is 21 days). Approximately 63 days. | Response was assessed by the Revised Response Criteria for Malignant Lymphoma criteria, and the Lugano Classification Response Criteria for Non-Hodgkin Lymphoma (NHL). Complete response (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms. The response rate will be determined by Kaplan-Meier method and reported along with a 95% confidence interval. |
| Secondary | Overall Survival (OS) | Time from enrollment to death, approximately 1 year | OS is defined as the time from the date of study enrollment until death from any cause, assessed every 3-6 months. OS will be determined by the Kaplan-Meier method and reported along with a 95% confidence interval. |
| Secondary | Event-free Survival (EFS) | Time from enrollment to next line of anti-lymphoma therapy, progressive disease, or death. Approximately 6 months. | EFS is defined as the time from the date of study enrollment until time of disease relapse from complete response (CR), disease progression, initiation of subsequent systemic anti-lymphoma therapy for either positron-emission tomography (PET)-positive or biopsy-proven residual disease, or death, whichever occurs first. The EFS will be determined by the Kaplan-Meier method and reported along with a 95% confidence interval. Response was assessed by the Revised Response Criteria for Malignant Lymphoma criteria, and the Lugano Classification Response Criteria for Non-Hodgkin Lymphoma (NHL). Complete response (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms. Progressive disease (PD) is appearance of any new nodal lesion ≥1.6 cm in greatest tumor dimension or ≥1.1 cm in short axis during or after the end of therapy. Disease relapse is Progressive disease (PD), an appearance of any new nodal lesion ≥1.6 cm in greatest tumor dimension. |
| Secondary | Number of Serious and/or Non-serious Grades 3-5 Adverse Events Related to Copanlisib | An average of 245.5 days | Rate and severity of adverse events (AEs) summarized by grade and type of toxicity. AE's were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, an average of 245.5 days | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Other | Number of Participants With Dose Limiting-toxicity (DLT) | 21 days | A DLT is any treatment-emergent, clinically relevant, and related severe (grade ≥ 3) toxicity that is possibly, probably or definitely related to copanlisib. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) | 21 days | Mg | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) | Response was assessed after cycles 1, 3 and 6 (each cycle is 21 days), approximately 63 days. | Percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) | Time from enrollment to progression or death, approximately 9 months. | Months | MEDIAN | |
| SECONDARY | Complete Response Rate | Response was assessed after cycles 1, 3 and 6 (each cycle is 21 days). Approximately 63 days. | Percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | Time from enrollment to death, approximately 1 year | Months | MEDIAN | |
| SECONDARY | Event-free Survival (EFS) | Time from enrollment to next line of anti-lymphoma therapy, progressive disease, or death. Approximately 6 months. | Months | MEDIAN | |
| SECONDARY | Number of Serious and/or Non-serious Grades 3-5 Adverse Events Related to Copanlisib | An average of 245.5 days | Adverse events | NUMBER | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, an average of 245.5 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Dose Limiting-toxicity (DLT) | 21 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) | All Participants | NA | Mg | ||
| Overall Response Rate (ORR) | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | Complete Response | 0 | 95% Confidence Interval 0 to 52.2 | Percentage of participants |
| Overall Response Rate (ORR) | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | Complete Response | 66.7 | 95% Confidence Interval 9.4 to 99.2 | Percentage of participants |
| Overall Response Rate (ORR) | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | Partial Response | 40 | 95% Confidence Interval 5.3 to 85.3 | Percentage of participants |
| Overall Response Rate (ORR) | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | Partial Response | 33.3 | 95% Confidence Interval 0.8 to 90.6 | Percentage of participants |
| Overall Response Rate (ORR) | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | Progressive Disease | 20 | 95% Confidence Interval 0.5 to 71.6 | Percentage of participants |
| Overall Response Rate (ORR) | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | Progressive Disease | 0 | 95% Confidence Interval 0 to 70.8 | Percentage of participants |
| Overall Response Rate (ORR) | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | Stable Disease | 40 | 95% Confidence Interval 5.3 to 85.3 | Percentage of participants |
| Overall Response Rate (ORR) | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | Stable Disease | 0 | 95% Confidence Interval 0 to 70.8 | Percentage of participants |
| Overall Response Rate (ORR) | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | Minimal Response | 0 | 95% Confidence Interval 0 to 52.2 | Percentage of participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation | STARTED | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | 5 | |
| Dose Escalation | STARTED | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 3 | |
| Dose Escalation | STARTED | Dose Escalation: Arm 1, Dose Level 2, Original: 45mg Copanlisib | 0 | |
| Dose Escalation | STARTED | Dose Escalation: Arm 1, Dose Level 1, Modified: 60mg Copanlisib | 0 | |
| Dose Escalation | STARTED | Arm 2 - Dose Expansion, Modified Copanlisib | 0 | |
| Dose Escalation | COMPLETED | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | 5 | |
| Dose Escalation | COMPLETED | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 0 | |
| Dose Escalation | COMPLETED | Dose Escalation: Arm 1, Dose Level 2, Original: 45mg Copanlisib | 0 | |
| Dose Escalation | COMPLETED | Dose Escalation: Arm 1, Dose Level 1, Modified: 60mg Copanlisib | 0 | |
| Dose Escalation | COMPLETED | Arm 2 - Dose Expansion, Modified Copanlisib | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | 3 | 5 | 8 |
| other | Anemia | Blood and lymphatic system disorders | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 0 | 3 | 0 |
| other | Anxiety | Psychiatric disorders | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | 2 | 5 | 2 |
| other | Anxiety | Psychiatric disorders | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 0 | 3 | 0 |
| other | Bacteremia | Infections and infestations | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | 1 | 5 | 1 |
| other | Bacteremia | Infections and infestations | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 0 | 3 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | 2 | 5 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 2 | 3 | 3 |
| other | Edema limbs | General disorders | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | 1 | 5 | 1 |
| other | Edema limbs | General disorders | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 0 | 3 | 0 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | 5 | 5 |
| Total, all-cause mortality | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 0 | 3 |
| Total, other adverse events | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | 5 | 5 |
| Total, other adverse events | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 3 | 3 |
| Total, serious adverse events | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | 2 | 5 |
| Total, serious adverse events | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib vs Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib: Number of Participants With Dose Limiting-toxicity (DLT) | Trial comparisons |
Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib vs Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib vs Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib: deaths from any cause | Trial comparisons |
| Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib vs Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04933617
GET https://conductscience.org/api/trials/v1/NCT04933617/results?page=2