Trial · NCT03192202
AFM13 in Relapsed/Refractory Cutaneous Lymphomas
NCT03192202, Phase 1, Phase 2, Completed, Ahmed Sawas; results first posted 2023-07-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AFM13 in Relapsed/Refractory Cutaneous Lymphomas. Trials, record NCT03192202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03192202
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AFM13 in Relapsed/Refractory Cutaneous Lymphomas
- NCT number
- NCT03192202
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Ahmed Sawas
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Interventions
- AFM13
- First posted
- 2017-06-20
- Last updated
- 2023-07-20
- Results first posted
- 2023-07-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Up to 2 years | Incidence of Treatment-Emergent Adverse Events \[Safety and Toxicity\] broken down by adverse event and CTCAE v4.0 grade of each event. |
| Secondary | Overall Response Rate (ORR) | Up to 2 years | The sum of patients with partial responses and complete responses. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response Rate (ORR) | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Cohort 1 | G3/4 Infection and skin rash | 1 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Cohort 2 | G3/4 Infection and skin rash | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Cohort 3 | G3/4 Infection and skin rash | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Cohort 4 | G3/4 Infection and skin rash | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Cohort 1 | G1 IRR | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Cohort 2 | G1 IRR | 2 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Cohort 3 | G1 IRR | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Cohort 4 | G1 IRR | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Cohort 1 | Death, G3 infection , IRR | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Cohort 2 | Death, G3 infection , IRR | 1 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 3 | |
| Overall Study | STARTED | Cohort 2 | 3 | |
| Overall Study | STARTED | Cohort 3 | 3 | |
| Overall Study | STARTED | Cohort 4 | 6 | |
| Overall Study | COMPLETED | Cohort 1 | 3 | |
| Overall Study | COMPLETED | Cohort 2 | 3 | |
| Overall Study | COMPLETED | Cohort 3 | 3 | |
| Overall Study | COMPLETED | Cohort 4 | 6 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events16
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 | Infusion related reaction (IRR) | General disorders | Cohort 1 | 0 | 3 | 0 |
| other | Infusion related reaction (IRR) | General disorders | Cohort 2 | 3 | 3 | 12 |
| other | Infusion related reaction (IRR) | General disorders | Cohort 3 | 0 | 3 | 0 |
| other | Infusion related reaction (IRR) | General disorders | Cohort 4 | 0 | 6 | 0 |
| serious | G3/4 Infection and skin rash | Skin and subcutaneous tissue disorders | Cohort 1 | 1 | 3 | 1 |
| serious | G3/4 Infection and skin rash | Skin and subcutaneous tissue disorders | Cohort 2 | 0 | 3 | 0 |
| serious | G3/4 Infection and skin rash | Skin and subcutaneous tissue disorders | Cohort 3 | 0 | 3 | |
| serious | G3/4 Infection and skin rash | Skin and subcutaneous tissue disorders | Cohort 4 | 0 | 6 | |
| serious | G1 IRR | General disorders | Cohort 1 | 0 | 3 | 0 |
| serious | G1 IRR | General disorders | Cohort 2 | 1 | 3 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 3 |
| Total, all-cause mortality | Cohort 2 | 1 | 3 |
| Total, all-cause mortality | Cohort 3 | 0 | 3 |
| Total, all-cause mortality | Cohort 4 | 0 | 6 |
| Total, other adverse events | Cohort 1 | 0 | 3 |
| Total, other adverse events | Cohort 2 | 3 | 3 |
| Total, other adverse events | Cohort 3 | 0 | 3 |
| Total, other adverse events | Cohort 4 | 0 | 6 |
| Total, serious adverse events | Cohort 1 | 1 | 3 |
| Total, serious adverse events | Cohort 2 | 1 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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/NCT03192202
GET https://conductscience.org/api/trials/v1/NCT03192202/registered