Clinical Trials Logo

Clinical Trial Summary

Protocol YY-20394-001 is a phase I open-label, first in human, dose escalation study to assess the tolerability, pharmacokinetics (PK) and efficacy of YY-20394 in patients with relapse or refractory B cell malignant hematological tumor.


Clinical Trial Description

This is a two-part study comprised of a dose escalation part and a dose expansion part.

In the dose escalation part single patient cohorts will be dosed until a single related toxicity of Grade ≥ 3 or a Dose Limiting Toxicity (DLT) is observed. If this occurs, the study will switch to a conventional oncology 3+3 design (3 patients per dose cohort, with the potential to add an additional 3 patients if toxicity is observed) and escalation will continue until the maximum tolerated dose (MTD) is reached and a recommended Phase II (RP2D) dose is determined. Once the MTD is established a separate dose expansion part will enroll up total additional 12 patients at the RP2D.

In this clinical trial, YY-20394 is given orally once daily. A treatment cycle is defined as 28 days. YY-20394 was given until disease progression, unacceptable toxicity, or withdrawal from the study. The protocol was initiated with a single-patient cohort, treated with oral YY-20394 20 mg once daily (QD). Subsequent cohorts used a 3+3 design and evaluated doses of 40-320mg QD. Adverse events (AEs) were graded by NCI-CTCAE v4.0. Efficacy was assessed according to IWG-NHL and CLL consensus response criteria. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03757000
Study type Interventional
Source Shanghai YingLi Pharmaceutical Co. Ltd.
Contact Hanying Bao, MD,PhD
Phone 86 21-51370693
Email hybao@yl-pharma.com
Status Recruiting
Phase Phase 1
Start date December 25, 2017
Completion date May 30, 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03204188 - Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Phase 2
Terminated NCT00377104 - Alvocidib in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Phase 1
Completed NCT00006226 - Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia Phase 2
Completed NCT01576588 - Rituximab in Pretreated Elderly or Unfit B-CLL Patients Phase 2
Completed NCT01212380 - Study of Carfilzomib in Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) or Prolymphocytic Leukemia (PLL) Phase 1
Terminated NCT00288067 - Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT00098670 - Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia Phase 2
Completed NCT00910910 - Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial) Phase 3
Recruiting NCT03110640 - Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma Phase 1
Terminated NCT00101205 - Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma Phase 1
Completed NCT00005799 - Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer N/A
Terminated NCT02440685 - A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors Phase 1/Phase 2
Completed NCT01105247 - Safety of PCI-32765 in Chronic Lymphocytic Leukemia Phase 1/Phase 2
Terminated NCT01126502 - Alvespimycin Hydrochloride in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia Phase 1
Completed NCT00321724 - AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia Phase 2
Completed NCT02381080 - Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy Phase 1
Completed NCT04030195 - Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL Phase 1/Phase 2
Withdrawn NCT00918450 - Study Assessing the Safety and Efficacy of ABT-263 in Subjects With B-cell Chronic Lymphocytic Leukemia (CLL) Who Have Failed at Least One Prior Fludarabine-containing Regimen Phase 2
Terminated NCT00302861 - A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Phase 1/Phase 2
Completed NCT00290472 - CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Phase 2