Health TrialsbyHealthPanel

R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

ConditionDiffuse Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Histologically confirmed newly diagnosed diffuse large B-cell lymphoma;

Patients must have been untreated, including chemotherapy, targeted therapy, immunotherapy, radiotherapy;

There must be at least one measurable lesion per the Lugano2014 criteria；

Disqualifiers

Primary central nervous system DLBCL, Primary testicular large B-cell lymphoma, Primary mediastinal (thymic) large B-cell lymphoma, Lymphomatoid granulomatosis, ALK-positive large B-cell lymphoma, Plasmablastic lymphoma, HHV8-positive DLBCL, Primary effusion lymphoma, Intravascular large B-cell lymphoma, B-cell lymphoma unclassifiable between DLBCL and classical Hodgkin lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, and High-grade B-cell lymphoma；

transformed indolent lymphoma ;

Patients with active central nervous system involvement;

History of hematopoietic stem cell transplantation;

Trial design

Design model

Single group

Treatments tested in this trial

  • Mitoxantrone Hydrochloride Liposome

    Drug

    assigned dose according to the 3+3 dose-escalation design in part 1, RP2D in part 2, D2

  • Rituximab (R)

    Drug

    375mg/m2, D2

  • Cyclophosphamide (CTX)

    Drug

    750mg/m2, D2

  • Vincristin

    Drug

    1.2mg/m2, maximum 2mg， D2

  • Prednisolone

    Drug

    60mg/m2, D2-6

Treatment groups

108 Participants
are divided into 1 treatment group
Group A: R-CMOPExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Phase I:Maximum tolerated dose (MTD)

Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in R-CMOP

Time frame
Through the last patient complete his DLT observation, assessed up to 21 days
2

Phase I: Recommended phaseII dose (RP2D)

The Recommended Phase II Dose (RP2D) is defined as the optimal dose of liposomal mitoxantrone hydrochloride for use in Phase II trials, as determined by the outcomes of the Phase I study.

Time frame
Through the last patient complete his DLT observation, assessed up to 21 days
3

Phase II:Complete remission rate (CRR)

Response is assessed according to the lugano criteria

Time frame
up to 2 years
4

Phase I: Dose limited toxicities (DLTs)

adverse events defined as DLT events per protocol

Time frame
Through the last patient complete his DLT observation, assessed up to 21 days

Secondary outcomes

1

Phase I: The incidence rates of adverse events (AEs)

AE or severe adverse events (SAE) occur since the first dose of therapy is given

Time frame
up to 2 years
2

Phase I: Objective response rate (ORR)

Response is assessed according to the lugano criteria

Time frame
up to 2 years
3

Phase I: Complete remission rate (CRR)

Response is assessed according to the lugano criteria

Time frame
up to 2 years
4

Phase II: Overall response rate (ORR)

Response is assessed according to the lugano criteria

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

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

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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