Allogeneic Cell Therapy in Refractory T-Cell Lymphoma
NCT07920393, Phase 2, Not yet recruiting, University Medical Center Goettingen
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Allogeneic Cell Therapy in Refractory T-Cell Lymphoma | ClinicalTrials.gov |
| NCT number | NCT07920393 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 70 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Medical Center Goettingen | ClinicalTrials.gov |
| Conditions | Lymphoma, T Cell, Peripheral | ClinicalTrials.gov |
| Interventions | Baseline FDG-PET/CT, First-line chemotherapy, Interim FDG-PET/CT after two cycles of first-line chemotherapy, End-of-treatment FDG-PET/CT after six cycles of first-line chemotherapy, Allogeneic hematopoietic cell transplantation | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Progression-free survival (PFS) in high-risk nodal PTCL patients (including chemotherapy-sensitive patients treated by chemotherapy alone and chemotherapy-refractory patients treated by chemotherapy followed by alloHCT) | From the first day of treatment until the end of the study (i.e., 2-year response assessment for the last patient included in the study) | Time from the first day of study treatment (first day of prephase in patients receiving a prephase, first day of cycle 1 in all other patients) until one of the following events occurs, whichever comes first: * investigator-assessed disease progression (PD), * relapse after complete metabolic response (CMR) or * death from any cause A switch to alloHCT due to iPET or EoT PET assessment without CT-based PD will not be counted as PFS event. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of adequate disease assessment. A Kaplan-Meier curve and the 2-year PFS rate with 95% confidence interval will be presented. | ClinicalTrials.gov |
| Secondary | Remission status at iPET (after 2 cycles of chemotherapy) | From the first day of treatment until 17-20 days after the second treatment cycle | Rate of PET/CT-defined complete metabolic response (CMR), non-CMR (including partial metabolic response \[PMR), overall metabolic response \[CMR + PMR\], no metabolic response \[NMR = stable metabolic disease \[SMD\]\], progressive metabolic disease \[PMD\], or unknown); rate of CT-defined complete remission (CR), partial remission (PR), overall response (OR = CR + PR), stable disease (SD), progressive disease (PD), or unknown, defined as the number of patients achieving this response divided by the number of patients analyzed | ClinicalTrials.gov |
| Secondary | Remission status after the end of chemotherapy (before possible alloHCT) | From the first day of treatment until 6-8 weeks after the sixth treatment cycle | Rate of PET/CT-defined complete metabolic response (CMR), non-CMR (including partial metabolic response \[PMR), overall metabolic response \[CMR + PMR\], no metabolic response \[NMR = stable metabolic disease \[SMD\]\], progressive metabolic disease \[PMD\], or unknown); rate of CT-defined complete remission (CR), partial remission (PR), overall response (OR = CR + PR), stable disease (SD), progressive disease (PD), or unknown, defined as the number of patients achieving this response divided by the number of patients analyzed | ClinicalTrials.gov |
| Secondary | Remission status after the end of first-line treatment (chemotherapy and possibly alloHCT) | From the first day of treatment until 6-8 weeks after the sixth treatment cycle (for patients treated by chemotherapy alone) or from the first day of treatment until 100 days after alloHCT (for patients treated by chemotherapy followed by alloHCT) | Rate of PET/CT-defined complete metabolic response (CMR), non-CMR (including partial metabolic response \[PMR), overall metabolic response \[CMR + PMR\], no metabolic response \[NMR = stable metabolic disease \[SMD\]\], progressive metabolic disease \[PMD\], or unknown); rate of CT-defined complete remission (CR), partial remission (PR), overall response (OR = CR + PR), stable disease (SD), progressive disease (PD), or unknown, defined as the number of patients achieving this response divided by the number of patients analyzed | ClinicalTrials.gov |
| Secondary | Response at the end of first-line treatment (chemotherapy and possibly alloHCT) | From the first day of treatment until 6-8 weeks after the sixth treatment cycle (for patients treated by chemotherapy alone) or from the first day of treatment until 100 days after alloHCT (for patients treated by chemotherapy followed by alloHCT) | Rate of complete remission (CR), partial remission (PR), overall response (OR = CR + PR), stable disease (SD), progressive disease (PD), death or unknown, defined as the number of patients achieving this response divided by the number of patients analyzed | ClinicalTrials.gov |
| Secondary | Overall survival (OS) in high-risk nodal PTCL patients (including chemotherapy-sensitive patients treated by chemotherapy alone and chemotherapy-refractory patients treated by chemotherapy followed by alloHCT) | From the first day of treatment until the end of the study (i.e., 2-year response assessment for the last patient included in the study) | Time from the first day of study treatment (first day of prephase in patients receiving a prephase, first day of cycle 1 in all other patients) until death from any cause. Patients who have not experienced an event at the time of analysis will be censored at the last date known to be alive. A Kaplan-Meier curve and the 2-year OS rate with 95% confidence interval will be presented. | ClinicalTrials.gov |
| Secondary | Time to progression (TTP) in high-risk nodal PTCL patients (including chemotherapy-sensitive patients treated by chemotherapy alone and chemotherapy-refractory patients treated by chemotherapy followed by alloHCT) | From the first day of treatment until the end of the study (i.e., 2-year response assessment for the last patient included in the study) | Time between the first day of study treatment (first day of prephase in patients receiving a prephase, first day of cycle 1 in all other patients) until one of the following events occurs, whichever comes first: * investigator-assessed disease progression (PD) or * relapse after complete metabolic response (CMR) Death without preceding PD or relapse will be counted as competing event. A cumulative incidence curve and the 2-year TTP rate with 95% confidence interval will be presented. | ClinicalTrials.gov |
| Secondary | Disease-free survival (DFS) in high-risk nodal PTCL patients (incl. chemotherapy-sensitive patients treated by chemotherapy alone and chemotherapy-refractory patients treated by chemotherapy followed by alloHCT) who achieve a complete metabolic response | From the day of achieving a complete metabolic response until the end of the study (i.e., 2-year response assessment for the last patient included in the study) | Time from complete metabolic response (CMR) after the end of protocol-based first-line treatment to disease relapse or death, whichever comes first. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of adequate disease assessment. A Kaplan-Meier curve will be presented. | ClinicalTrials.gov |
| Secondary | Graft-versus-host disease-free and relapse-free survival (GRFS) in chemotherapy-refractory high-risk nodal PTCL patients undergoing alloHCT | From the day of alloHCT until the end of the study (i.e., 2-year response assessment for the last patient included in the study) | Time from the day of alloHCT until one of the following events occurs, whichever comes first: * grades III or IV acute graft-versus-host disease, * chronic graft-versus-host disease requiring systemic treatment, * investigator-assessed disease progression, * relapse after complete metabolic response (CMR) or * death from any cause Patients who have not experienced an event at the time of analysis will be censored at the most recent date of adequate disease assessment. A Kaplan-Meier curve will be presented. | ClinicalTrials.gov |
| Secondary | Relapse rate | From the day of achieving a complete metabolic response until the end of the study (i.e., 2-year response assessment for the last patient included in the study) | Number of relapses after complete metabolic response (CMR) divided by the number of patients with complete metabolic response (CMR) after the end of protocol-based first line treatment | ClinicalTrials.gov |
| Secondary | Rate of patients allocated to alloHCT on the basis of iPET, EoT PET, disease progression or relapse | From the first day of treatment until the end of the study (i.e., 2-year response assessment for the last patient included in the study) | Number of patients with a positive iPET and no investigator-assessed progressive disease (PD), number of patients with a positive EoT PET and no investigator-assessed progressive disease (PD), number of patients with investigator-assessed disease progression (PD) on therapy, number of patients with relapse after a complete metabolic response (CMR) divided by the number of patients analyzed | ClinicalTrials.gov |
| Secondary | Rate of patients undergoing alloHCT according to study protocol | From the first day of treatment until the end of the study (i.e., 2-year response assessment for the last patient included in the study) | Number of patients undergoing alloHCT according to study protocol divided by the number of patients analyzed | ClinicalTrials.gov |
| Secondary | Protocol adherence | From the first day of treatment until the end of six cycles of first-line chemotherapy | Number of chemotherapy treatment cycles received, duration of chemotherapy treatment cycles, cumulative dose of chemotherapy The results will be presented in tables. | ClinicalTrials.gov |
| Secondary | Safety and tolerability of protocol-based first-line treatment | From the first day of treatment until the end of the study (i.e., 2-year response assessment for the last patient included in the study) | Number of adverse events, serious adverse events, treatment-related deaths, acute and chronic graft-versus-host disease, secondary malignancies The results will be presented in frequency tables. | ClinicalTrials.gov |
| Secondary | Time to non-relapse mortality (NRM) | From the first day of treatment until the end of the study (i.e., 2-year response assessment for the last patient included in the study) | Time between the first day of study treatment (first day of prephase in patients receiving a prephase, first day of cycle 1 in all other patients) until death without preceding investigator-assessed PD or relapse after complete metabolic response (CMR). PD/relapse will be counted as competing event. A cumulative incidence curve and the 2-year NRM rate with 95% confidence interval will be presented. | ClinicalTrials.gov |
| Secondary | Quality of life of patients | From the first day of treatment until the 2-year response assessment | Assessment before treatment, at iPET, at EoT PET/CT, before and after alloHCT and at 6, 12 and 24 months of follow-up using the EORTC QLQ-C30 questionnaire The domains of the questionnaire will be evaluated according to the EORTC QLQ-C30 Scoring Manual and presented sequentially for each of the above time-points. For each domain, the responses given by the patients will be displayed on a scale from 0 to 100 (mean of all responses plus standard deviation; median of all responses plus interquartile range). | 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)