Peripheral Blood Stem Cell TransplantationPhase 1/2NCT05075681

Ruxolitinib and Chidamide for Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma

A Phase 1/2 study testing Modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide in people with Peripheral Blood Stem Cell Transplantation, run by Chinese PLA General Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation. Read more about this study

Who is it for?: Ages 12 to 65 years
Conditions the study is for: Peripheral Blood Stem Cell Transplantation
What is being tested?: Modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: 1 Nov 2021to 1 Jun 2025
Phase: Phase 1/2
Are there results?: None posted in the registry

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 12 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

high risk Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma with the indications for allogeneic transplantation;
Have haploidentical donors
All patients should aged 12 to 65 years;
Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal;
Renal function: creatinine ≤the upper limit of normal;
Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
Have signed informed consent.

Who cannot join

pregnant women;
Patients with mental illness or other states unable to comply with the protocol;

Trial locations and contacts

1 site in 1 country.

Daihong Liu contact

Liping Dou contact

China1 site, 1 recruiting

Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jiang Cao, 01066937166
Recruiting

Other trials in China

About this study

Official title: Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen for Patients With Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma Underwenting Haploidenticl Peripheral Blood Stem Cell Transplantation

Read the detailed description

Haploidenticl Peripheral blood Stem Cell Transplantation should be offered to eligible patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma whenever feasible. To further improve the outcome of transplantation patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma, we developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. In this study, we tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide in patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma undergoing allogeneic peripheral blood stem cell transplantation.

Conditions: Peripheral Blood Stem Cell Transplantation
Being tested: Modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Modified By/Cy conditioning regimen intensified by Ruxolitinib and ChidamideDrug
Also called Ruxolitinib and Chidamide
Drug: modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide.
Day -15 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -14 # Ruxolitinib 70mg bid; Day -13 # Ruxolitinib 70mg bid; Day -12 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -11 # Ruxolitinib 70mg bid; Day-10# Cytarabine 4g/m2/day CI (only for Haploidentical and unrelated donor), Ruxolitinib 60mg bid; Day- 9# Cytarabine 4g/m2/day CI, Ruxolitinib 60mg bid; Day- 8 # Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid, Chidamide 30 mg once; Day- 7# Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid; Day-6# Busulfan 0.8mg/kg Q6h iv, Ruxolitinib 40mg bid; Day-5# Cyclophosphamide 1.8 g/m2/day CI, Ruxolitinib 30mg bid, Chidamide 30 mg once; Day-4# Cyclophosphamide 1.8 g/m2/day CI,Ruxolitinib 20mg bid; Day-3# Carmustine 250mg/m2/ day iv, Ruxolitinib 10mg bid; Day-2# Ruxolitinib 5mg bid, Chidamide 30 mg/day; Day-1# Ruxolitinib 5mg qd;

Study groups in NCT05075681
Study group	Role	What they receive
Ruxolitinib combined with Chidamide	Experimental	All recipients in this arm received the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. The conditioning regimen for allogeneic hematopoietic stem cell transplantation consist of ruxolitinib (35 mg bid [p.o.], days -15 to -10, diminishing to day -1), chidamide (30 mg/day, twice per week from days -15 to -2), cytarabine (4g/m2/day, days -10 to -9), busulfan (0.8mg/kg, Q6h, days -8 to -6), cyclophosphamide (1.8 g/m2/day, days -5 to -4), carmustine(BCNU) (250mg/m2/day, day -3) Receives: Drug: Modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria
Defined as the proportion of participants whose underlying malignancy relapsed.
Measured: 365 days after transplantation

Secondary outcomes (7)

DFS(disease-free survival )
DFS was defined as survival with no evidence of relapse or progression.
Measured: 365 days after transplantation
TRM(treatment-related mortality )
Defined as the proportion of subjects who died due to causes other than malignancy relapse.
Measured: 365 days after transplantation
Proportion of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)
Defined as the proportion of participants who developed acute GVHD.
Measured: 100 days after transplantation
Proportion of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)
Defined as the proportion of participants who developed chronic GVHD.
Measured: 365 days after transplantation
OS(overall survival )
OS was defined as the time from transplantation to death due to any cause.
Measured: 365 days after transplantation
Failure-free survival (FFS)
Defined as the time from transplantation to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD).
Measured: 365 days after transplantation
infection rate
Defined as the proportion of participants who developed all kinds of infection.
Measured: 365 days after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20211 Jun 2025

First posted13 Oct 2021
Study start1 Nov 2021
Primary completion1 Jun 2024 (estimated)
Study completion1 Jun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Peripheral Blood Stem Cell TransplantationStudies of the same condition, open and under way.
More trials run by Chinese PLA General HospitalThe 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05075681
Sponsor's protocol ID: S-2020-483-01
Status last verified: Dec 2021
First submitted: 25 May 2021
Last updated: 14 Dec 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ferrante F, Giaimo BD, Bartkuhn M, Zimmermann T, Close V, Mertens D, Nist A, Stiewe T, Meier-Soelch J, Kracht M, Just S, Kloble P, Oswald F, Borggrefe T. HDAC3 functions as a positive regulator in Notch signal transduction. Nucleic Acids Res. 2020 Apr 17;48(7):3496-3512. doi: 10.1093/nar/gkaa088.
PubMed 32107550
Maude SL, Dolai S, Delgado-Martin C, Vincent T, Robbins A, Selvanathan A, Ryan T, Hall J, Wood AC, Tasian SK, Hunger SP, Loh ML, Mullighan CG, Wood BL, Hermiston ML, Grupp SA, Lock RB, Teachey DT. Efficacy of JAK/STAT pathway inhibition in murine xenograft models of early T-cell precursor (ETP) acute lymphoblastic leukemia. Blood. 2015 Mar 12;125(11):1759-67. doi: 10.1182/blood-2014-06-580480. Epub 2015 Feb 2.
PubMed 25645356
Delgado-Martin C, Meyer LK, Huang BJ, Shimano KA, Zinter MS, Nguyen JV, Smith GA, Taunton J, Winter SS, Roderick JR, Kelliher MA, Horton TM, Wood BL, Teachey DT, Hermiston ML. JAK/STAT pathway inhibition overcomes IL7-induced glucocorticoid resistance in a subset of human T-cell acute lymphoblastic leukemias. Leukemia. 2017 Dec;31(12):2568-2576. doi: 10.1038/leu.2017.136. Epub 2017 May 9.
PubMed 28484265
Shi Y, Jia B, Xu W, Li W, Liu T, Liu P, Zhao W, Zhang H, Sun X, Yang H, Zhang X, Jin J, Jin Z, Li Z, Qiu L, Dong M, Huang X, Luo Y, Wang X, Wang X, Wu J, Xu J, Yi P, Zhou J, He H, Liu L, Shen J, Tang X, Wang J, Yang J, Zeng Q, Zhang Z, Cai Z, Chen X, Ding K, Hou M, Huang H, Li X, Liang R, Liu Q, Song Y, Su H, Gao Y, Liu L, Luo J, Su L, Sun Z, Tan H, Wang H, Wang J, Wang S, Zhang H, Zhang X, Zhou D, Bai O, Wu G, Zhang L, Zhang Y. Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China. J Hematol Oncol. 2017 Mar 15;10(1):69. doi: 10.1186/s13045-017-0439-6.
PubMed 28298231
Stumpel DJ, Schneider P, Seslija L, Osaki H, Williams O, Pieters R, Stam RW. Connectivity mapping identifies HDAC inhibitors for the treatment of t(4;11)-positive infant acute lymphoblastic leukemia. Leukemia. 2012 Apr;26(4):682-92. doi: 10.1038/leu.2011.278. Epub 2011 Oct 21.
PubMed 22015773
Lato MW, Przysucha A, Grosman S, Zawitkowska J, Lejman M. The New Therapeutic Strategies in Pediatric T-Cell Acute Lymphoblastic Leukemia. Int J Mol Sci. 2021 Apr 26;22(9):4502. doi: 10.3390/ijms22094502.
PubMed 33925883

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen for Patients With Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma Underwenting Haploidenticl Peripheral Blood Stem Cell Transplantation
ClinicalTrials.gov ID: NCT05075681
Acronym / sponsor ID: S-2020-483-01
Conditions: Peripheral Blood Stem Cell Transplantation
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Chinese PLA General HospitalUniversity, hospital or other
Study start: 1 Nov 2021 (actual)
Primary completion: 1 Jun 2024 (estimated)
Study completion: 1 Jun 2025 (estimated)
First posted: 13 Oct 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ruxolitinib combined with Chidamide	Experimental	Drug: Modified By/Cy conditioning regimen intensified by Ruxolitinib and ChidamideAll recipients in this arm received the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. The conditioning regimen for allogeneic hematopoietic stem cell transplantation consist of ruxolitinib (35 mg bid [p.o.], days -15 to -10, diminishing to day -1), chidamide (30 mg/day, twice per week from days -15 to -2), cytarabine (4g/m2/day, days -10 to -9), busulfan (0.8mg/kg, Q6h, days -8 to -6), cyclophosphamide (1.8 g/m2/day, days -5 to -4), carmustine(BCNU) (250mg/m2/day, day -3)

Who may qualify

Ages: 12 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

high risk Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma with the indications for allogeneic transplantation;
Have haploidentical donors
All patients should aged 12 to 65 years;
Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal;
Renal function: creatinine ≤the upper limit of normal;

Key exclusion criteria (2 listed)

pregnant women;
Patients with mental illness or other states unable to comply with the protocol;

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
Modified By/Cy conditioning regimen intensified by Ruxolitinib and ChidamideAlso: Ruxolitinib and ChidamideDrug: modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. Day -15 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -14 # Ruxolitinib 70mg bid; Day -13 # Ruxolitinib 70mg bid; Day -12 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -11 # Ruxolitinib 70mg bid; Day-10# Cytarabine 4g/m2/day CI (only for Haploidentical and unrelated donor), Ruxolitinib 60mg bid; Day- 9# Cytarabine 4g/m2/day CI, Ruxolitinib 60mg bid; Day- 8 # Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid, Chidamide 30 mg once; Day- 7# Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid; Day-6# Busulfan 0.8mg/kg Q6h iv, Ruxolitinib 40mg bid; Day-5# Cyclophosphamide 1.8 g/m2/day CI, Ruxolitinib 30mg bid, Chidamide 30 mg once; Day-4# Cyclophosphamide 1.8 g/m2/day CI,Ruxolitinib 20mg bid; Day-3# Carmustine 250mg/m2/ day iv, Ruxolitinib 10mg bid; Day-2# Ruxolitinib 5mg bid, Chidamide 30 mg/day; Day-1# Ruxolitinib 5mg qd;	Drug	Ruxolitinib combined with Chidamide

Primary outcome

Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria
Time frame: 365 days after transplantation
Defined as the proportion of participants whose underlying malignancy relapsed.

7 secondary outcomes

DFS(disease-free survival )
Time frame: 365 days after transplantation
TRM(treatment-related mortality )
Time frame: 365 days after transplantation
Proportion of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)
Time frame: 100 days after transplantation
Proportion of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)
Time frame: 365 days after transplantation
OS(overall survival )
Time frame: 365 days after transplantation
Failure-free survival (FFS)
Time frame: 365 days after transplantation
infection rate
Time frame: 365 days after transplantation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
Background: PubMed 32107550Ferrante F, Giaimo BD, Bartkuhn M, Zimmermann T, Close V, Mertens D, Nist A, Stiewe T, Meier-Soelch J, Kracht M, Just S, Kloble P, Oswald F, Borggrefe T. HDAC3 functions as a positive regulator in Notch signal transduction. Nucleic Acids Res. 2020 Apr 17;48(7):3496-3512. doi: 10.1093/nar/gkaa088.
Background: PubMed 25645356Maude SL, Dolai S, Delgado-Martin C, Vincent T, Robbins A, Selvanathan A, Ryan T, Hall J, Wood AC, Tasian SK, Hunger SP, Loh ML, Mullighan CG, Wood BL, Hermiston ML, Grupp SA, Lock RB, Teachey DT. Efficacy of JAK/STAT pathway inhibition in murine xenograft models of early T-cell precursor (ETP) acute lymphoblastic leukemia. Blood. 2015 Mar 12;125(11):1759-67. doi: 10.1182/blood-2014-06-580480. Epub 2015 Feb 2.
Background: PubMed 28484265Delgado-Martin C, Meyer LK, Huang BJ, Shimano KA, Zinter MS, Nguyen JV, Smith GA, Taunton J, Winter SS, Roderick JR, Kelliher MA, Horton TM, Wood BL, Teachey DT, Hermiston ML. JAK/STAT pathway inhibition overcomes IL7-induced glucocorticoid resistance in a subset of human T-cell acute lymphoblastic leukemias. Leukemia. 2017 Dec;31(12):2568-2576. doi: 10.1038/leu.2017.136. Epub 2017 May 9.
Background: PubMed 28298231Shi Y, Jia B, Xu W, Li W, Liu T, Liu P, Zhao W, Zhang H, Sun X, Yang H, Zhang X, Jin J, Jin Z, Li Z, Qiu L, Dong M, Huang X, Luo Y, Wang X, Wang X, Wu J, Xu J, Yi P, Zhou J, He H, Liu L, Shen J, Tang X, Wang J, Yang J, Zeng Q, Zhang Z, Cai Z, Chen X, Ding K, Hou M, Huang H, Li X, Liang R, Liu Q, Song Y, Su H, Gao Y, Liu L, Luo J, Su L, Sun Z, Tan H, Wang H, Wang J, Wang S, Zhang H, Zhang X, Zhou D, Bai O, Wu G, Zhang L, Zhang Y. Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China. J Hematol Oncol. 2017 Mar 15;10(1):69. doi: 10.1186/s13045-017-0439-6.
Background: PubMed 22015773Stumpel DJ, Schneider P, Seslija L, Osaki H, Williams O, Pieters R, Stam RW. Connectivity mapping identifies HDAC inhibitors for the treatment of t(4;11)-positive infant acute lymphoblastic leukemia. Leukemia. 2012 Apr;26(4):682-92. doi: 10.1038/leu.2011.278. Epub 2011 Oct 21.
Background: PubMed 33925883Lato MW, Przysucha A, Grosman S, Zawitkowska J, Lejman M. The New Therapeutic Strategies in Pediatric T-Cell Acute Lymphoblastic Leukemia. Int J Mol Sci. 2021 Apr 26;22(9):4502. doi: 10.3390/ijms22094502.

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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. This study is not recruiting at the moment.

Daihong Liu contact

Liping Dou contact

Daihong Liu principal investigator

Chinese PLA General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Dec 2021. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daihong Liu (86-13681171597, daihongrm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria (time frame: 365 days after transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05075681, which also lists 6 linked publications.

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 14 Dec 2021.