B-cell Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I Study of YY-20394 Given Orally to Patients With Relapsed or Refractory B Cell Hematologic Malignancies
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.
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.
;
| 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 | |
| Terminated |
NCT01126502 -
Alvespimycin Hydrochloride in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia
|
Phase 1 | |
| Completed |
NCT01105247 -
Safety of PCI-32765 in Chronic Lymphocytic Leukemia
|
Phase 1/Phase 2 | |
| 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 |