B-cell Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I Dose-Escalation Study of Flavopiridol (NSC 649890) Administered as a 30 Minute Loading Dose Followed by a 4-Hour Infusion in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Following Cytoreduction With Chemotherapy
This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as alvocidib, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVES:
I. Determine the toxicity profile, dose-limiting toxicity, and maximum tolerated dose of
flavopiridol (alvocidib) as consolidation chemotherapy after cytoreduction chemotherapy in
patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics and cellular pharmacodynamics of flavopiridol in these
patients.
II. Determine the complete response (CR) and overall response rate (CR and partial response)
of patients treated with flavopiridol.
OUTLINE: This is a dose-escalation study. Patients receive alvocidib intravenously (IV) over
30 minutes (loading dose), followed by alvocidib IV over 4 hours on days 1, 8, and 15.
Treatment repeats every 5 weeks for up to 2 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total
of 12 patients are treated at the MTD (i.e., recommended phase II dose). Patients undergo
blood collection at baseline and periodically during study for pharmacokinetic and cytokine
studies (levels of tumor necrosis factor-alpha, interleukin [IL]-6, -11, and -16) by
enzyme-linked immunosorbent assay (ELISA). Interphase cytogenetics, p53 mutational status,
p53/ATM function, V_H mutational status, zeta-chain-associated protein kinase 70 (ZAP-70)
overexpression, and single nucleotide polymorphisms are also examined.
After completion of study treatment, patients are followed at 2 months and then every 3
months for 5 years.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 | |
| 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 |
NCT00565981 -
A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
|
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 |