A Phase 2 interventional study of Baseline FDG-PET/CT and First-line chemotherapy in Lymphoma, T Cell, Peripheral, sponsored by University Medical Center Goettingen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University Medical Center Goettingen · Phase 2, Interventional, and Treatment
The REACT study is for people with a rare type of cancer called T-cell lymphoma. T-cell lymphoma affects cells that are part of the body's immune system.
Most lymphomas develop from B cells. Lymphomas that develop from T cells are much rarer. There are several different types of T-cell lymphoma, and many of them grow quickly. Without treatment, people with aggressive T-cell lymphoma may die within weeks or months. Even when the first treatment is successful, only about 25 to 40 out of 100 patients are still alive without the lymphoma returning two years after diagnosis.
Treatment usually involves several courses of chemotherapy, given every two or three weeks. In most patients, the lymphoma becomes smaller during treatment. However, in about one in three patients, the lymphoma starts to grow again while they are still receiving treatment. In other patients, the lymphoma becomes smaller but does not disappear completely. In these cases, it often returns within weeks or months after treatment has finished.
Stem cell transplantation
If the lymphoma gets worse during treatment or returns soon afterwards, a blood stem cell transplant may offer the best chance of a cure. This treatment replaces the patient's immune system with a new immune system from a healthy donor, which can recognize and eliminate the lymphoma cells.
For a stem cell transplant, doctors need to find a healthy donor whose tissue characteristics are a good match for the patient. These characteristics can be checked with a blood test. Sometimes a suitable donor can be found within the patient's family. More often, doctors search for an unrelated volunteer donor whose information is stored in a donor database.
A stem cell transplant has a better chance of being successful if the lymphoma can first be brought under control with additional chemotherapy.
In everyday clinical practice, however, stem cell transplantation is often delayed or cannot be reached. For example, it may take time to find a suitable donor, or treatment given after the lymphoma has returned may fail. Additional treatment may also make patients weaker and less able to undergo a stem cell transplant.
For these reasons, it is important to identify patients whose lymphoma is not responding well to their first treatment as early as possible. Patients whose lymphoma returns only several years after their first treatment generally have a better outlook.
What is different in the REACT study?
The REACT study uses two main approaches. First, the search for a suitable stem cell donor starts soon after diagnosis for all patients taking part in the study. This means that a donor may already be available if a stem cell transplant becomes necessary.
Second, patients have a special scan after only two courses of chemotherapy. This scan combines computed tomography (CT) with positron emission tomography (PET) and is called a PET/CT scan. The scan shows how well the lymphoma is responding to treatment. It can help doctors identify patients who have a high risk of the lymphoma returning.
The researchers hope that combining an early donor search with early PET/CT scans will improve the treatment of T-cell lymphoma. If the scan suggests that the lymphoma is likely to return, doctors can consider a stem cell transplant earlier, while the patient is still in a good enough condition to receive it.
Who can take part?
Patients may be able to take part in the REACT study if their doctors believe that a blood stem cell transplant from a family member or an unrelated donor would be suitable for them. They must also have one of the following types of T-cell lymphoma:
If the early PET/CT scan suggests a high risk that the lymphoma will return, or if the lymphoma actually returns, doctors will aim to carry out a stem cell transplant as soon as possible. If standard chemotherapy works well and there are no signs that the lymphoma is likely to return, a stem cell transplant is not performed.
The overall aim of the REACT study is to identify patients at high risk of relapse earlier and, when needed, make stem cell transplantation possible at an earlier and potentially more effective stage of treatment.
Scientific background
Peripheral T-cell lymphoma (PTCL) is a rare group of diseases. There are nodal, extranodal and leukemic forms, the latter two predominating in Asia. The major nodal entities are anaplastic large cell lymphoma (ALCL), PTCL, not otherwise specified (NOS), and nodal T-follicular helper cell lymphoma (nTFHL) with its major subtype angioimmunoblastic T-cell lymphoma (AITL).
Except for anaplastic lymphoma kinase (ALK)-positive ALCL, the prognosis of nodal PTCL is poor, with 2-year progression-free survival (PFS) rates of 27-40%. The focus of the REACT study is nodal ALK-negative PTCL, here collectively referred to as high-risk nodal PTCL. The three entities PTCL-NOS, AITL, and ALK-negative ALCL constitute about half of all PTCL cases.
A particular feature of PTCL is primary refractory disease. Despite response to the first few treatment cycles, about a third of patients suffer progression on continued therapy, and among those without overt progression, a substantial number fail to reach a complete remission at the end of treatment (EoT). Because salvage protocols have limited anti-T-cell lymphoma activity, most primary refractory patients never achieve a remission and succumb to their disease. Patients relapsing after a longer period of disease control fare better, because allogeneic transplantation (alloHCT), the single most effective treatment modality, is curative in about half of the patients transplanted. The major hurdle preventing patients with primary refractory disease from undergoing alloHCT is progression, which may be overcome by identification of such patients before progression occurs. Toxicities from salvage therapies further reduce the number of patients able to receive an allogeneic transplant.
In the PTCL subgroup of the PETAL trial (ClinicalTrials.gov NCT00554164), a large multi-center lymphoma trial performed in Germany, 18Fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) identified PTCL patients with treatment failure before overt progression occurred. This finding may open a window of opportunity for alloHCT for a substantial proportion of patients with otherwise devastating prognosis. First-line alloHCT as consolidation after CHOEP induction therapy was pioneered in non-selected PTCL patients in the German-French AATT trial (ClinicalTrials.gov NCT00984412).
The novelty in the design of the REACT study is not in the treatment regimens, but in the use of interim PET/CT to perform alloHCT in chemotherapy-refractory patients early during first-line therapy. The underlying hypothesis is that early recognition of treatment failure will allow the affected patients to undergo alloHCT in good condition and at low tumor burden, which may improve survival for the entire high-risk nodal PTCL group.
Rationale for choice of control interventions/comparators
REACT is a non-randomized study without control intervention. The outcome of patients with iPET-defined treatment failure continuing chemotherapy is dismal. Medical ethics preclude random allocation of such patients to continued chemotherapy vs. alloHCT. The results of the REACT study will be compared with those of the PETAL trial where chemotherapy was continued irrespective of the iPET result, representing the current standard of care.
Risk-benefit assessment
About 40% of high-risk nodal PTCL patients experience chemotherapy-refractory disease in the course of first-line treatment, with less than 20% alive after 30 months. Treatment options for such patients are very limited. There are no promising drug treatments for chemotherapy-refractory high-risk nodal PTCL patients. AlloHCT offers a promising approach for patients with iPET-defined treatment failure that would until now be continued on chemotherapy. AlloHCT has a potent graft-versus-PTCL effect, it represents the only cellular immunotherapy option against PTCL. AlloHCT is associated with procedure-associated risks of infections and graft-versus-host disease, amounting to a 1-year transplantation-related mortality of 20% upon application of reduced-intensity conditioning (RIC). As alloHCT following RIC achieves long-term survival for 50-60% of patients with relapsed or refractory PTCL with otherwise fatal outlook, the benefits of early transplantation outweigh its risks.
The investigations and assessments to be performed throughout the study mainly represent procedures that are performed in PTCL patients according to good medical practice in inpatient and outpatient care. Therefore, these procedures are not expected to pose a specific extended risk to the patient above that of routine care. Most procedures beyond routine patient care such as upfront HLA typing, upfront initiation of a donor search, standardized interim staging by PET/CT, quality-of-life questionnaires and blood-sampling for translational research projects are of added value and do not impose relevant strains.
Moreover, the fact that patients included in this study are closely monitored by an interdisciplinary team, by reference pathologists and reference nuclear medicine physicians and by an independent Data and Safety Monitoring Board, measures that go far beyond routine care, may provide substantial medical benefits by itself.
In summary, there is substantial evidence for a positive benefit-to-risk-ratio for the patients included in this study for both transplant-specific and non-transplant-specific assessments.
Objectives, endpoints and estimands
The primary objective of the REACT study is to assess the progression-free survival (PFS) and the 2-year PFS rate of high-risk nodal PTCL patients. The 2-year PFS rate is an established endpoint in PTCL. The primary endpoint combines chemotherapy-sensitive patients treated by chemotherapy alone and chemotherapy-refractory patients switching from chemotherapy to alloHCT. Chemotherapy refractoriness prompting a protocol-mandated, response-dependent switch to alloHCT is defined as
relapse within the first 2 years after the first day of treatment after achieving a complete metabolic response at EoT PET/CT.
Based on the literature and the PETAL historical control group, the 2-year PFS rate is estimated to be 40% for patients treated by chemotherapy alone. With up to six cycles of chemotherapy for chemotherapy-sensitive patients and an early switch to alloHCT in chemotherapy-refractory patients, the 2-year PFS rate is expected to rise to at least 55% (Scientific Steering Committee decision).
In addition, PFS will be compared to the literature and the PETAL historical control group.
Secondary objectives are to assess the remission status at iPET (after 2 cycles of chemotherapy), after the end of chemotherapy and after the end of protocol-based first-line treatment, the response after the end of protocol-based first-line treatment and to assess overall survival, time to progression and disease-free survival. Further secondary objectives are to assess graft-versus-host disease-free and relapse-free survival and the relapse rate. Another secondary objective is to quantify the number of patients allocated to alloHCT, the rate of patients undergoing alloHCT and quality of life.
Safety objectives are adverse events and non-relapse mortality.
Primary estimand
The primary efficacy endpoint is progression-free survival (PFS).
The primary estimand is defined accordingly with the following 5 attributes:
Population: AlloHCT eligible patients ≥ 18 years diagnosed with previously untreated high-risk nodal peripheral T-cell lymphoma (PTCL) starting treatment, including
Intercurrent event strategies:
Study design
This is a multicenter, non-randomized, non-blinded clinical study with response-dependent switch to alloHCT for chemotherapy-refractory high-risk nodal PTCL patients.
The treatments represent standard procedures for patients with chemotherapy-sensitive disease (chemotherapy) or chemotherapy-refractory disease (immunotherapy), respectively. The study results will be compared with a historical control group (from the phase III PETAL trial) that received first-line chemotherapy without a response-dependent switch to immunotherapy.
Standard Treatment
PTCL-NOS or nTFHL (including AITL): CHO(E)P regimen
ALK-negative ALCL : BV-CHP regimen
Allogeneic transplantation
Matched related donor (MRD) / matched unrelated donor (MUD): TBI-8/fludarabine regimen or Fludarabine/busulfan regimen (FB8)
Haploidentical donor: TBI-8/fludarabine or a protocol based on alkylating agents integrating thiotepa/fludarabine; post-transplantation cyclophosphamide (PTCY) following conditioning therapy is recommended
Permitted additional antineoplastic therapies outside the study protocol
The above protocols for standard chemotherapy must be adhered to and any deviation must be documented and justified. The alloHCT conditioning regimens represent recommendations. In two instances, additional antineoplastic measures are allowed at the discretion of the investigators:
Assessment of quality of life
The quality of life of the study participants is evaluated using the EORTC QLQ-C30 Quality-of-Life Questionnaire.
Longitudinal assessment of time-to-event endpoints
The longitudinal endpoints evaluated in the REACT study rely on PET/CT-defined treatment response criteria (CMR, non-CMR [including partial metabolic response [PMR], no metabolic response [NMR = stable metabolic disease, SMD] and progressive metabolic disease [PMD], CT-defined treatment response categories (CR, PR, OR [CR + PR], SD, PD), relapse after CMR, occurrence and grade of acute or chronic graft-versus-host-disease, death from PD or relapse, non-relapse mortality and death from any cause.
Monitoring procedure
Monitoring is performed according to ICH-GCP E6 and SOPs to verify that study participants' rights and well-being are protected, reported study data are accurate, complete and verifiable and that the study is conducted in compliance with the currently approved protocol/amendment.
Monitoring visits at the study site take place before, during and after the clinical study.
Only large cancer centers with departments of hematology, bone marrow transplantation and nuclear medicine [FDG-PET/CT accredited by the European Association of Nuclear Medicine Research Ltd., EANM/EARL] and adequately staffed clinical studies offices will be selected for the study. All study-specific monitoring procedures, monitoring visit frequency and extent of source data verification (SDV) is described in a study-specific monitoring manual.
Auditing procedures
According to the ICH-GCP guidelines, audits may be performed as a quality measure. Audits may be conducted by the coordinating investigators or an independent external party.
Sample size calculation
The primary aim of the study regarding efficacy is to estimate the 2-year PFS rate.
With up to six cycles of chemotherapy for chemotherapy-sensitive patients and an early switch to alloHCT in chemotherapy-refractory patients, the 2-year PFS rate is hypothesized to be at least 55% (Scientific Steering Committee decision). With a sample size of 70 patients starting treatment within the study, the 95% confidence interval would have a precision of about -/ + 12% and allows excluding a PFS rate at 2 years below 43%, taken into account about 5% patients censored until 2 years.
An explorative analysis of patients treated within this study compared to patients from the PETAL trial will be performed. Comparing for example PFS curves between 70 REACT and 50 comparable patients from the PETAL trial (2-year PFS rate about 40%) using the logrank test, an approximately 25% difference (HR=0.47) in 2-year PFS rates can be detected with a power of 80% and a two-sided significance level of 5%.
Definition of analysis sets
The full-analysis set (FAS) will include all consenting and registered patients receiving at least one treatment component within the study.
The per-protocol set (PPS) will include all consenting and registered patients meeting the inclusion criteria, receiving at least one study treatment component and without major protocol violations.
The safety analysis set (SAS) will include all consenting and registered patients receiving at least one treatment component within the study and is identical to FAS.
Baseline characteristics
Demographics and other baseline data will be summarized descriptively.
Primary endpoint
The primary efficacy analysis will determine the 2-year PFS rate with 95% confidence interval using a Kaplan-Meier curve within FAS.
Secondary endpoints
The secondary endpoints OS, DFS and GRFS will be analyzed using the same statistical methods as for the primary endpoint. TTP will be analyzed using cumulative incidence curves. Multivariate Cox regression models will be performed for prognostic factors. The rate of remission status based on the PET portion of PET/CT (CMR, non-CMR [including PMR, NMR = SMD, PMD, unknown), the rate of remission status based on the CT portion of PET/CT (CR, PR, OR (CR + PR), SD, PD, or unknown), the rate of response (CR, PR, OR (CR + PR), SD, PD, death or unknown) and the relapse rate will be documented together with the corresponding 95% confidence intervals (Clopper-Pearson).
Qualitative endpoints, such as (serious) adverse events, acute and chronic GvHD, secondary malignancies and biological parameters will be presented in frequency tables. Quantitative endpoints will be described in tables displaying sample size, range, mean and standard deviation or median and quartiles, or will be presented graphically.
All AEs and SAEs with their severity grade and relationship to treatment will be listed per patient and summarized for all patients together.
Subgroup analysis
Subgroup analyses regarding sex, IPI risk factors, IPI score, age groups, histological PTCL subtypes, molecular subgroups, allocation to alloHCT or availability of donor are planned.
Sensitivity analysis
Analyses for efficacy endpoints based on the PPS population are planned as sensitivity analysis in order to assess the robustness of the results obtained from the FAS population.
Further sensitivity analyses will be described in the statistical analysis plan (SAP), if necessary.
Final analysis
The final analysis of the study will be performed after LPLFU and all study documentation is completed as well as the corrections of all CRFs are final (database lock).
Biometrical report
The results of the final analysis will be presented in a final statistical report. This will provide a description of the patient population, adherence to protocol, the safety of the therapy (particularly in respect of the occurrence of AEs and SAEs), cases of early discontinuation and the results of the efficacy analysis.
Scientific Steering Committee (SSC)
The Steering Committee of the REACT study takes responsibility for the scientific validity of the study protocol, assessment of study quality and conduct as well as for the scientific quality of the final study report.
Data and safety monitoring board (DSMB)
The DSMB of the REACT study is composed of four independent experts from the fields of hematological oncology, allogeneic blood stem cell transplantation, nuclear medicine and biostatistics. The DSMB will advise the steering committee to continue, modify or stop the study.
Critical non-conformities
The term non-conformity refers to the failure to meet specific requirements. It is an umbrella term which includes, for example, protocol deviations, violation of regulatory requirements, non-compliance with internal or external standards, product deficiencies or other undesirable situations. When the study site or any other party involved in the conduct of the study identifies a critical non-conformity, the study site is responsible to inform the coordinating investigators of the clinical study immediately.
372 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 110 are open to participants now.
This study's planned enrollment of 70 is above the median of 44 across 328 interventional studies indexed under Lymphoma, T-Cell, Peripheral.
Browse Lymphoma, T-Cell, Peripheral studies →University Medical Center Goettingen is the lead sponsor of 62 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Treatment-naïve peripheral T-cell non-Hodgkin lymphoma of one of the following types confirmed by a reference pathologist:
peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
nodal T-follicular helper cell lymphoma (nTFHL) including the types
anaplastic lymphoma kinase-negative anaplastic large cell lymphoma (ALK-negative ALCL)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with previously untreated high-risk nodal peripheral T-cell lymphoma (PTCL) including: * Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS); * Nodal T-follicular helper cell lymphoma (nTFHL); * Anaplastic lymphoma kinase (ALK)-negative anaplastic large cell lymphoma (ALCL). All patients will receive up to 6 cycles of standard chemotherapy in accordance with established guidelines for chemotherapy-sensitive high-risk nodal PTCL patients. A response-dependent switch to allogeneic hematopoietic cell transplantation (alloHCT) for patients with chemotherapy-refractory, high-risk nodal PTCL (i.e., chemotherapy followed by alloHCT) will be considered in the presence of any of the following: * Interim PET/CT: Persistent visible lymphoma lesions with a reduction in SUVmax of \<50% compared with baseline; * End-of-treatment (EoT) PET/CT: Deauville score of 4 or 5; * Progressive disease during treatment; * Relapse after achievement of a complete metabolic response.
Diagnostic Test: Baseline FDG-PET/CT · Drug: First-line chemotherapy · Diagnostic Test: Interim FDG-PET/CT after two cycles of first-line chemotherapy · Diagnostic Test: End-of-treatment FDG-PET/CT after six cycles of first-line chemotherapy · Biological: Allogeneic hematopoietic cell transplantation
Baseline PET/CT is performed before any treatment is administered. Patients with lymphoma lesions identified by FDG-PET are candidates for participation in the study.
Patients with PTCL-NOS or nTFHL above the age of 60 receive up to 6 cycles of CHOP, patients with these conditions below the age of 60 receive up to 6 cycles of CHOP plus etoposide, and patients with ALK-negative ALCL receive up to 6 cycles of BV-CHP.
Interim PET/CT is performed 17-20 days after the second cycle of chemotherapy. Persistent visible lymphoma lesions with a reduction in SUVmax of \<50% compared with baseline SUVmax indicate chemotherapy-refractory disease.
End-of-treatment PET/CT is performed 6-8 weeks after the sixth cycle of chemotherapy. A Deauville score of 4 or 5 indicates chemotherapy-refractory disease.
Patients with refractory disease identified at interim FDG-PET/CT or end-of-treatment FDG-PET/CT, patients with overt progression during first-line treatment and patients with relapse after achieving a complete metabolic response after first-line treatment are candidates for allogeneic hematopoietic cell transplantation.
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)
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.
Time frame: 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)
Remission status at iPET (after 2 cycles of chemotherapy)
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
Time frame: From the first day of treatment until 17-20 days after the second treatment cycle
Remission status after the end of chemotherapy (before possible 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
Time frame: From the first day of treatment until 6-8 weeks after the sixth treatment cycle
Remission status after the end of first-line treatment (chemotherapy and possibly 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
Time frame: 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)
Response at the end of first-line treatment (chemotherapy and possibly 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
Time frame: 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)
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)
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.
Time frame: 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 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)
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.
Time frame: 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)
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
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.
Time frame: 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)
Graft-versus-host disease-free and relapse-free survival (GRFS) in chemotherapy-refractory high-risk nodal PTCL patients undergoing alloHCT
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.
Time frame: 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)
Relapse rate
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
Time frame: 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)
Rate of patients allocated to alloHCT on the basis of iPET, EoT PET, disease progression or relapse
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
Time frame: 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)
Rate of patients undergoing alloHCT according to study protocol
Number of patients undergoing alloHCT according to study protocol divided by the number of patients analyzed
Time frame: 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)
Protocol adherence
Number of chemotherapy treatment cycles received, duration of chemotherapy treatment cycles, cumulative dose of chemotherapy The results will be presented in tables.
Time frame: From the first day of treatment until the end of six cycles of first-line chemotherapy
Safety and tolerability of protocol-based first-line treatment
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.
Time frame: 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 to non-relapse mortality (NRM)
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.
Time frame: 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)
Quality of life of patients
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).
Time frame: From the first day of treatment until the 2-year response assessment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Lymphoma, T-Cell, Peripheral →
University Medical Center Goettingen