Lenalidomide and Cosibelimab for the Treatment of Relapsed/Refractory Mycosis Fungoides or Sézary Syndrome
NCT07926893, Phase 1, Not yet recruiting, City of Hope Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Lenalidomide and Cosibelimab for the Treatment of Relapsed/Refractory Mycosis Fungoides or Sézary Syndrome | ClinicalTrials.gov |
| NCT number | NCT07926893 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 14 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | City of Hope Medical Center | ClinicalTrials.gov |
| Conditions | Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome, Recurrent Transformed Mycosis Fungoides, Refractory Mycosis Fungoides, Refractory Sezary Syndrome, Refractory Transformed Mycosis Fungoides, 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 | ClinicalTrials.gov |
| Interventions | Biospecimen Collection, Computed Tomography, Cosibelimab, Lenalidomide, Positron Emission Tomography, Questionnaire Administration, Skin Biopsy | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of dose limiting toxicities (DLT) | From baseline, up to completion of cycle 3 (cycle length = 21 days) | Defined as any of the following toxicity that occur during the first 3 cycles of treatment, and that are attributed as possibly, probably, or definitely related to protocol therapy. Toxicities include immune related toxicities, hematologic toxicities, specific non hematologic toxicities, any toxicity that would, in the opinion of the principal investigator, prevent continued administration of the combination treatment, or any toxicity that prevents the planned dose escalation of lenalidomide in cycles 1-3. DLT (if any) will be individually described. | ClinicalTrials.gov |
| Primary | Incidence of adverse events | Up to 1 year | Toxicities will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0. Observed toxicities will be summarized by type, severity, time of onset, and attribution. | ClinicalTrials.gov |
| Secondary | Overall response | Up to 1 year | Defined as a response-evaluable patient achieving a documented complete response (CR) or partial response (PR) after start of protocol therapy and prior to progression/relapse/start of non-protocol anti-lymphoma treatment. Exact 95% confidence intervals will be calculated. | ClinicalTrials.gov |
| Secondary | Complete response | Up to 1 year | Defined as a response-evaluable patient achieving a documented CR after start of protocol therapy and prior to progression/relapse/start of non-protocol anti-lymphoma treatment. Exact 95% confidence intervals will be calculated. | ClinicalTrials.gov |
| Secondary | Time to response | From initiation of study therapy to the first achievement of CR or PR prior to progression/relapse/start of non-protocol anti-lymphoma treatment, up to 1 year | Will be summarized descriptively. | ClinicalTrials.gov |
| Secondary | Sustained response | Up to 1 year | Defined as a response-evaluable patient achieving an objective response (CR/PR) that lasts at least 4 months prior to progression/relapse/start of non-protocol anti-lymphoma treatment. Exact 95% confidence intervals will be calculated. | ClinicalTrials.gov |
| Secondary | Duration of response | From the first achievement of PR or CR to time of progression/relapse or death, up to 1 year | Will be estimated using the product-limit method of Kaplan and Meier. | ClinicalTrials.gov |
| Secondary | Progression free survival | From initiation of study therapy to disease relapse/progression or death from any cause, up to 1 year | Will be estimated using the product-limit method of Kaplan and Meier. | ClinicalTrials.gov |
| Secondary | Overall survival | From initiation of study therapy to death from any cause, up to 1 year | Will be estimated using the product-limit method of Kaplan and Meier. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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 | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)