Trial · NCT04541017
Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment
NCT04541017, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2025-10-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment. Trials, record NCT04541017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04541017
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment
- NCT number
- NCT04541017
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Mycosis Fungoides, Recurrent Mycosis Fungoides, Recurrent Mycosis Fungoides and Sezary Syndrome, Recurrent Sezary Syndrome, Refractory Mycosis Fungoides, Refractory Mycosis Fungoides and Sezary Syndrome, Refractory Sezary Syndrome, Sezary Syndrome, Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8
- Interventions
- Biospecimen Collection, Computed Tomography, Magrolimab, Mogamulizumab, Positron Emission Tomography, Punch Biopsy
- First posted
- 2020-09-09
- Last updated
- 2025-10-16
- Results first posted
- 2025-10-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 Dose (RP2D) of Magrolimab When Given in Combination With Mogamulizumab (Phase Ib) | Up to 4 weeks from the first infusion of magrolimab (priming infusion) | The phase 1b portion of the trial was designed to determine a RP2D of Hu5F9-G4 (magrolimab) and was planned to enroll 6-18 patients. |
| Primary | Overall Response Rate at 6 Months (ORR6) (Phase II) | At 6 months | Will be defined as the proportion of patients who have a partial or complete response to therapy AND a duration of response \>= 6 months. Will use a stratified Cochran-Mantel-Haenszel chi-squared test to compare between-group differences in ORR6 proportion. Will also conduct a secondary analysis on the intent-to-treat population (all patients randomized to a therapy and assigned a study number) and an efficacy evaluable set (all patients who received the first 12 weeks of treatment and completed the week 12 response assessment). |
| Secondary | Overall Response Rate (ORR) (Phase Ib) | Up to 2 years | Defined as the proportion of patients who have a partial or complete response to therapy as defined by the global response score. |
| Secondary | Overall Response Rate at 4 Months (ORR4) (Phase II) | At 4 months | Will be defined as the proportion of patients who have a partial or complete response to therapy AND a duration of response \>= 4 months. Will be assessed by the chi-squared method. |
| Secondary | Overall Response Rate at 12 Months (ORR12) (Phase II) | At 12 months | Will be defined as the proportion of patients who have a partial or complete response to therapy AND a duration of response \>= 12 months. Will be assessed by the chi-squared method. |
| Secondary | Progression-free Survival (PFS) (Phase II) | From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years | Will be assessed by the Kaplan-Meier method and the log-rank test. |
| Secondary | Duration of Response (DOR) (Phase II) | From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrence or progressive disease is objectively documented, assessed up to 2 years | Will be assessed by the Kaplan-Meier method and the log-rank test. |
| Secondary | Time to Next Treatment (TTNT) (Phase II) | From the start of treatment on this protocol to time of the next anti-neoplastic therapy, assessed up to 2 years | Will be assessed by the Kaplan-Meier method and the log-rank test. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Phase 2 Dose (RP2D) of Magrolimab When Given in Combination With Mogamulizumab (Phase Ib) | Up to 4 weeks from the first infusion of magrolimab (priming infusion) | The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug. | mg/kg | NUMBER |
| PRIMARY | Overall Response Rate at 6 Months (ORR6) (Phase II) | At 6 months | The Phase II portion of the study was never opened. The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug. | ||
| SECONDARY | Overall Response Rate (ORR) (Phase Ib) | Up to 2 years | The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate at 4 Months (ORR4) (Phase II) | At 4 months | The Phase II portion of the study was never opened. The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug. | ||
| SECONDARY | Overall Response Rate at 12 Months (ORR12) (Phase II) | At 12 months | The Phase II portion of the study was never opened. The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug. | ||
| SECONDARY | Progression-free Survival (PFS) (Phase II) | From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years | The Phase II portion of the study was never opened. The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug. | ||
| SECONDARY | Duration of Response (DOR) (Phase II) | From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrence or progressive disease is objectively documented, assessed up to 2 years | The Phase II portion of the study was never opened. The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug. | ||
| SECONDARY | Time to Next Treatment (TTNT) (Phase II) | From the start of treatment on this protocol to time of the next anti-neoplastic therapy, assessed up to 2 years | The Phase II portion of the study was never opened. The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Phase 2 Dose (RP2D) of Magrolimab When Given in Combination With Mogamulizumab (Phase Ib) | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 30 | mg/kg | ||
| Overall Response Rate (ORR) (Phase Ib) | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 2 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 6 | |
| Overall Study | STARTED | Arm II (Mogamulizumab), Phase II | 0 | |
| Overall Study | COMPLETED | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 6 | |
| Overall Study | COMPLETED | Arm II (Mogamulizumab), Phase II | 0 | |
| Overall Study | NOT COMPLETED | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Mogamulizumab), Phase II | 0 |
Source ClinicalTrials.gov
Adverse events104
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 | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 2 | 6 | 15 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Mogamulizumab), Phase II | 0 | 0 | 0 |
| other | Other: Hemagglutination | Blood and lymphatic system disorders | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 1 | 6 | 1 |
| other | Other: Hemagglutination | Blood and lymphatic system disorders | Arm II (Mogamulizumab), Phase II | 0 | 0 | 0 |
| other | ST changes on EKG | Cardiac disorders | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 1 | 6 | 2 |
| other | ST changes on EKG | Cardiac disorders | Arm II (Mogamulizumab), Phase II | 0 | 0 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 1 | 6 | 6 |
| other | Ear pain | Ear and labyrinth disorders | Arm II (Mogamulizumab), Phase II | 0 | 0 | 0 |
| other | Other: Muscle spasm | Ear and labyrinth disorders | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 1 | 6 | 2 |
| other | Other: Muscle spasm | Ear and labyrinth disorders | Arm II (Mogamulizumab), Phase II | 0 | 0 | 0 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 0 | 6 |
| Total, all-cause mortality | Arm II (Mogamulizumab), Phase II | 0 | 0 |
| Total, other adverse events | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 6 | 6 |
| Total, other adverse events | Arm II (Mogamulizumab), Phase II | 0 | 0 |
| Total, serious adverse events | Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II | 3 | 6 |
| Total, serious adverse events | Arm II (Mogamulizumab), Phase II | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186717 | Phase 1 and 2 Molecular and Clinical Pharmacodynamic Trials ETCTN | DANILOV, ALEXEY V.; COLEVAS, A. DIMITRIOS; LARA, PRIMO N.; LENZ, HEINZ JOSEF | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04541017
GET https://conductscience.org/api/trials/v1/NCT04541017/events?page=2