Peripheral T Cell LymphomaPhase 2NCT05958719
Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma
A Phase 2 study testing Chidamide, Azacitidine and liposomal mitoxantrone in people with Peripheral T Cell Lymphoma and Epigenetic Repression, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This study is investigating the effectiveness (specifically the objective response rate - ORR) of a new combination therapy called CAMP (chidamide, azacitidine, liposomal mitoxantrone, and prednisone) for previously untreated angioimmunoblastic T-cell lymphoma (AITL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma, Epigenetic Repression
- What is being tested?
- Chidamide, Azacitidine and liposomal mitoxantrone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2023to 2 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma.
- More than 18 years of age.
- Proper functioning of the major organs: 1) The absolute value of neutrophils (≥1×10^9/L); 2) platelet count (≥75×10^9/L); 3) Serum total bilirubin ≤ 1.5 times ULN; 4) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN; 5) Serum creatinine (Cr) ≤2 ULN, or glomerular filtration rate ≥40ml/min;
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- LVEF value measured by echocardiography ≥50%.
- Life expectancy > 3 months.
Who cannot join
- Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy.
- Patients with central nervous system involvement by lymphoma.
- Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
- Pregnant or breastfeeding women.
- Presence of human immunodeficiency virus (HIV) virus infection.
- Previous history of other malignant tumors, unless the disease has been cured for 5 years or more. The following cured tumors are excluded:
- Basal cell carcinoma of the skin, squamous cell carcinoma of the skin and related localized non-melanoma skin cancers;
- Carcinoma in situ of the cervix
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Dehui Zou, Dr., 86-022-23909282, zoudehui@ihcams.ac.cn
Huimin Liu, Dr., 86-022-23909282, liuhuimin@ihcams.ac.cn
About this study
Official title: Evaluation of Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for Reviously Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma
This study is investigating the effectiveness (specifically the objective response rate - ORR) of a new combination therapy called CAMP (chidamide, azacitidine, liposomal mitoxantrone, and prednisone) for previously untreated angioimmunoblastic T-cell lymphoma (AITL). It's a single-arm study comparing CAMP's safety and efficacy to standard treatments. Younger patients (≤70) receive the full CAMP regimen, while older patients receive a modified version (CAMP-light). Patients are assessed via PET-CT after 4 cycles. Responders (CR/PR) receive consolidation therapy and then maintenance chidamide for 2 years. Eligible patients achieving CR after 4 cycles can get a transplant, while those with PR need 2 more cycles first. Patients with stable or progressive disease after 4 cycles are withdrawn. Progression at any time leads to study discontinuation.
Read the detailed description
Main Objective:
The primary objective of this study is to investigate the objective response rate (ORR) of chidamide in combination with azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for the treatment of treatment-naïve angioimmunoblastic T-cell lymphoma (AITL).
Study Design:
This study employs a single-arm design, based on the hypothesis that the safety profile of the chidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) is superior to conventional treatment regimens, and that the efficacy, as measured by ORR, is non-inferior to conventional treatment regimens. Patients meeting the inclusion/exclusion criteria will be treated according to age: patients ≤70 years old will receive the CAMP regimen as first-line therapy, while patients >70 years old will receive a modified CAMP regimen (CAMP-light) as first-line therapy. Interim efficacy will be assessed via PET-CT scan after the 4th cycle of chemotherapy, with PET-CT results interpreted using the Deauville 5-point scale.
Treatment and Follow-up:
Patients achieving a complete response (CR) or partial response (PR) at the interim assessment will continue with 2 cycles of consolidation therapy using the CAMP regimen or CAMP-light regimen. Subsequently, they will enter single-agent chidamide maintenance therapy (≤70 years old: chidamide 30mg orally, twice weekly; >70 years old: chidamide 20mg orally, twice weekly), which will continue for 24 months.
Patients eligible for transplantation who achieve a CR after 4 cycles of induction therapy may proceed to autologous stem cell transplantation (ASCT). Patients achieving a PR will receive 2 additional cycles of consolidation therapy before undergoing ASCT. Patients with a PR at the interim assessment will undergo a repeat PET-CT scan before transplantation to reassess efficacy. Stem cell mobilization for transplant-eligible patients will utilize steady-state mobilization with or without plerixafor.
Patients exhibiting stable disease (SD) or progressive disease (PD) at the interim assessment after 4 cycles will be withdrawn from the study.
Patients experiencing PD at any time during the treatment course will be discontinued from the study upon confirmation of progression.
- Conditions
- Peripheral T Cell Lymphoma, Epigenetic Repression
- Being tested
- Chidamide, Azacitidine, liposomal mitoxantrone, prednisone
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
chidamide 30mg biw, p.o, 21 days for a cycle.
AzacitidineDrug
75mg/m2, continuous i.h. on day 1-7，21 days for a cycle.
liposomal mitoxantroneDrug
12mg/m2， d1,21 days for a cycle.
prednisoneDrug
60mg/m2，d1-5,21 days for a cycle.
| Study group | Role | What they receive |
|---|---|---|
| interim evaluation of CR group | Experimental | Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated with chidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for four cycles. For patients with interim-PET evaluation of CR, consolidation therapy with ASCT or another two cycles with CAMP regimen can be obtained. Subsequently,chidamide monotherapy was given as maintenance therapy for 24 months. Patients with interim evaluation of SD or PD withdrew from this study. Receives: Drug: Chidamide; Drug: Azacitidine; Drug: liposomal mitoxantrone; Drug: prednisone |
| interim evaluation of PR group | Experimental | Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated withchidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for four cycles. For patients with interim-PET evaluation of PR, another two cycles of CAMP regimen will be continued, followed by the second PET-CT efficacy evaluation, and those who achieve CR receive consolidation therapy with ASCT and following chidamide maintenance. Subsequently, chidamide monotherapy was given as maintenance therapy for 24 months. Patients with second efficacy evaluation of PR or SD or PD withdrew from this study. Receives: Drug: Chidamide; Drug: Azacitidine; Drug: liposomal mitoxantrone; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification by PET-CT as determined by study investigators.
Measured: 2 years post initiation of treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 2 years post initiation of treatment
Secondary outcomes (3)
Progression-Free Survival (PFS)
PFS is defined as the time from the initiation of treatment to the date of disease progression or death from any cause.
Measured: 2 years post initiation of treatment
Duration of Response (DOR)
DOR is defined for participants who experience complete response after treatment and is the time from the first objective response to disease progression or death from any cause.
Measured: 2 years post initiation of treatment
Overall Survival (OS)
OS is defined as the time from initiation of treatment to the date of death from any cause.
Measured: 2 years post initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start2 Mar 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zou Dehui, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- Dehui Zou, Dr., Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958719
- Sponsor's protocol ID
- IIT2023003
- Status last verified
- Dec 2024
- First submitted
- 4 Jul 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for Reviously Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05958719
- Acronym / sponsor ID
- IIT2023003
- Conditions
- Peripheral T Cell Lymphoma, Epigenetic Repression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 2 Mar 2027 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is investigating the effectiveness (specifically the objective response rate - ORR) of a new combination therapy called CAMP (chidamide, azacitidine, liposomal mitoxantrone, and prednisone) for previously untreated angioimmunoblastic T-cell lymphoma (AITL). It's a single-arm study comparing CAMP's safety and efficacy to standard treatments. Younger patients (≤70) receive the full CAMP regimen, while older patients receive a modified version (CAMP-light). Patients are assessed via PET-CT after 4 cycles. Responders (CR/PR) receive consolidation therapy and then maintenance chidamide for 2 years. Eligible patients achieving CR after 4 cycles can get a transplant, while those with PR need 2 more cycles first. Patients with stable or progressive disease after 4 cycles are withdrawn. Progression at any time leads to study discontinuation.
Detailed description
Main Objective:
The primary objective of this study is to investigate the objective response rate (ORR) of chidamide in combination with azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for the treatment of treatment-naïve angioimmunoblastic T-cell lymphoma (AITL).
Study Design:
This study employs a single-arm design, based on the hypothesis that the safety profile of the chidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) is superior to conventional treatment regimens, and that the efficacy, as measured by ORR, is non-inferior to conventional treatment regimens. Patients meeting the inclusion/exclusion criteria will be treated according to age: patients ≤70 years old will receive the CAMP regimen as first-line therapy, while patients >70 years old will receive a modified CAMP regimen (CAMP-light) as first-line therapy. Interim efficacy will be assessed via PET-CT scan after the 4th cycle of chemotherapy, with PET-CT results interpreted using the Deauville 5-point scale.
Treatment and Follow-up:
Patients achieving a complete response (CR) or partial response (PR) at the interim assessment will continue with 2 cycles of consolidation therapy using the CAMP regimen or CAMP-light regimen. Subsequently, they will enter single-agent chidamide maintenance therapy (≤70 years old: chidamide 30mg orally, twice weekly; >70 years old: chidamide 20mg orally, twice weekly), which will continue for 24 months.
Patients eligible for transplantation who achieve a CR after 4 cycles of induction therapy may proceed to autologous stem cell transplantation (ASCT). Patients achieving a PR will receive 2 additional cycles of consolidation therapy before undergoing ASCT. Patients with a PR at the interim assessment will undergo a repeat PET-CT scan before transplantation to reassess efficacy. Stem cell mobilization for transplant-eligible patients will utilize steady-state mobilization with or without plerixafor.
Patients exhibiting stable disease (SD) or progressive disease (PD) at the interim assessment after 4 cycles will be withdrawn from the study.
Patients experiencing PD at any time during the treatment course will be discontinued from the study upon confirmation of progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interim evaluation of CR group | Experimental | Drug: Chidamide, Drug: Azacitidine, Drug: liposomal mitoxantrone, Drug: prednisoneUntreated patients with TFH-derived peripheral T-cell lymphoma will be treated with chidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for four cycles. For patients with interim-PET evaluation of CR, consolidation therapy with ASCT or another two cycles with CAMP regimen can be obtained. Subsequently,chidamide monotherapy was given as maintenance therapy for 24 months. Patients with interim evaluation of SD or PD withdrew from this study. |
| interim evaluation of PR group | Experimental | Drug: Chidamide, Drug: Azacitidine, Drug: liposomal mitoxantrone, Drug: prednisoneUntreated patients with TFH-derived peripheral T-cell lymphoma will be treated withchidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for four cycles. For patients with interim-PET evaluation of PR, another two cycles of CAMP regimen will be continued, followed by the second PET-CT efficacy evaluation, and those who achieve CR receive consolidation therapy with ASCT and following chidamide maintenance. Subsequently, chidamide monotherapy was given as maintenance therapy for 24 months. Patients with second efficacy evaluation of PR or SD or PD withdrew from this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma.
- More than 18 years of age.
- Proper functioning of the major organs: 1) The absolute value of neutrophils (≥1×10^9/L); 2) platelet count (≥75×10^9/L); 3) Serum total bilirubin ≤ 1.5 times ULN; 4) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN; 5) Serum creatinine (Cr) ≤2 ULN, or glomerular filtration rate ≥40ml/min;
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- LVEF value measured by echocardiography ≥50%.
Key exclusion criteria (8 listed)
- Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy.
- Patients with central nervous system involvement by lymphoma.
- Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
- Pregnant or breastfeeding women.
- Presence of human immunodeficiency virus (HIV) virus infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chidamidechidamide 30mg biw, p.o, 21 days for a cycle. | Drug | interim evaluation of CR group, interim evaluation of PR group |
| Azacitidine75mg/m2, continuous i.h. on day 1-7，21 days for a cycle. | Drug | interim evaluation of CR group, interim evaluation of PR group |
| liposomal mitoxantrone12mg/m2， d1,21 days for a cycle. | Drug | interim evaluation of CR group, interim evaluation of PR group |
| prednisone60mg/m2，d1-5,21 days for a cycle. | Drug | interim evaluation of CR group, interim evaluation of PR group |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years post initiation of treatment
ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification by PET-CT as determined by study investigators.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 2 years post initiation of treatment
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2 years post initiation of treatment
Duration of Response (DOR)
Time frame: 2 years post initiation of treatment
Overall Survival (OS)
Time frame: 2 years post initiation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dehui Zou, Dr. principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide, Azacitidine and liposomal mitoxantrone in people with Peripheral T Cell Lymphoma and Epigenetic Repression, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dehui Zou, Dr. (86-022-23909282, zoudehui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 2 years post initiation of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.