Health TrialsbyHealthPanel

A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma

ConditionNewly Diagnosed Diffuse Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorMingzhi Zhang

About this trial

A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with newly Diagnosed Diffuse Large B-cell Lymphoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals aged 65 years or older who are intolerant to chemotherapy, regardless of gender;

ECOG 0-1； IPI score ≤ 3 points;

Expected survival period of more than 3 months;

DLBCL diagnosed by tissue biopsy pathology;

Disqualifiers

Clear patients with neurological or psychiatric disorders, including dementia or seizures, a history of abuse of psychotropic drugs that cannot be quit, or other substantial lesions that may increase central neurotoxicity;

Individuals who are currently participating in other clinical trials or have participated in other clinical studies within the first 4 weeks of enrollment (excluding those who have not received treatment);

Systemic autoimmune diseases or immunodeficiency;

Refusing to collect blood samples;

Trial design

Design model

Single group

Treatments tested in this trial

  • Obutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone

    Drug

    For non GCB type: Rituximab, 375mg/m2, QD, D1,8,15(the first cycle), d1(Starting from the second cycle), ivgtt; Compound Cyclophosphamide Tablets, 50mg:50mg BID, P.O.; Obutinib, 150mg, QD, P.O.; Prednisone, 60mg, QD D1-7, P.O. Every 21 days is a cycle, and the efficacy is evaluated every 2 cycles. Obutinib maintain treatment for 6 months. Obutinib, 150mg, QD, P.O. After 6 cycles of initial treatment, the efficacy was evaluated. For GCB type: Rituximab, 375mg/m2, QD, D1,8,15(the first cycle), d1(Starting from the second cycle), ivgtt; Compound Cyclophosphamide Tablets, 50mg:50mg BID, P.O.; Decitabine, 10mg, QD，D1-5, ivgtt; Prednisone, 60mg, QD D1-7, P.O. Every 21 days is a cycle, and the efficacy is evaluated every 2 cycles. Decitabine maintenance treatment for 4 cycles, 21 days per cycle. Decitabine, 10mg, QD，D1-5, ivgtt. Evaluate the efficacy after 6 cycles of treatment.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Elderly patients with newly diagnosed DLBCLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

Overall Response Rate

Time frame
two years
2

Progression Free Survival (PFS)

Progression Free Survival

Time frame
two years

Secondary outcomes

1

Overall Survival (OS)

Overall Survival

Time frame
two years
2

Disease free survival（DFS）

Disease free survival

Time frame
two years

Other outcomes

Sponsors and contacts

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

Mingzhi Zhang

Lead sponsor

Zhengzhou University

Sponsor institution

Source ClinicalTrials.gov
Apply now