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Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL)

ConditionNodal T-follicular Helper Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University

About this trial

This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed nTFHL classified by WHO-HAEM5, including nodal TFH cell lymphoma, angioimmunoblastic-type, nodal TFH cell lymphoma, follicular-type, Nodal TFH cell lymphoma, NOS

Patients planning to receive autologous hematopoietic stem cell transplantation;

No previous systemic treatment before enrollment.;

There is at least one measurable lesion: the longest diameter (LDi) of the lymph node lesion is greater than 1.5 cm, or the LDi of one extra lymph node lesion is greater than 1 cm (according to the 2014 Lugano classification);

Disqualifiers

Known allergy to the active ingredients or excipients of linperlisib and CHOP regimens.

Patients with factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);

Medical History and comorbidity

The subject had any active, known, or suspected autoimmune disease. Subjects who are in a stable state and do not require systemic immunosuppressive therapy are admitted;

Trial design

Design model

Single group

Treatments tested in this trial

  • linperlisib combined with CHOP regimen

    Drug

    Induction therapy: cyclophosphamide 750 mg/m2 day1, doxorubicin 40-50 mg/m2 day1, vincristine 1.4 mg/m2 (max 2 mg) day1, prednisone 100 mg day1-5, linperlisib 80mg once a day，day1-21, repeat every 21 days, for 6 cycle. Consolidation therapy: high dose chemotherapy followed by autologous hematopoietic stem cell transplantation. Maintenance therapy: linperlisib 80 mg day1-28, up to 12 cycles.

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: linperlisib combined with CHOP regimenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

progression-free survival

PFS will be calculated from the start of study drug treatment to the date of disease progression, death, or last follow-up, as appropriate.

Time frame
2 year

Secondary outcomes

1

ORR

ORR is defined as sum of CR and PR rates, as assessed by the Investigator according to the Lugano Classification

Time frame
After 6 cycles of induction therapy ，average of 4.2 month and post transplantation
2

CR rate

CR rate is defined as the percentage of patients showing complete response as assessed by the Investigator according to the Lugano Classification.

Time frame
After 6 cycles of induction therapy ，average of 4.2 month and post transplantation
3

Success rate of stem cell collection

Success rate was assessed as the number of participants who achieved the target collection of CD34+cells ≥ 2×10\^6/kg .

Time frame
1day before performing an autologous hematopoietic stem cell transplant
4

overall survival (OS)

OS will be calculated from the start of study drug treatment to the date of disease death or last follow-up, as appropriate.

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University

Lead sponsor

Source ClinicalTrials.gov
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