Alvocidib in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT00377104 | Terminated Phase 1

• 6 other identifiers: NCI-2009-00161OSU 05116OSU-IRB-2006C0031CDR0000501975OSU-05116U01CA076576
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

B-cell Chronic Lymphocytic Leukemia; Contiguous Stage II Small Lymphocytic Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Stage I Chronic Lymphocytic Leukemia; Stage I Small Lymphocytic Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage III Small Lymphocytic Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (2)

• Toxicity profile of alvocidib administered as a 30 minute loading dose followed by a 4-hour infusion once weekly for 3 consecutive weeks every 5 weeks as consolidation therapy following cytoreduction chemotherapy

  Assessed utilizing the NCI Common Terminology Criteria for Adverse Events version 3.0.

  Day 1, every 2 courses, at 2 months and then every 3 months for 5 years after completion of study treatment

• Dose-limiting toxicity of alvocidib as consolidation chemotherapy after cytoreduction chemotherapy in patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma

  The National Cancer Institute Common Toxicity Criteria version 3.0 will be used to characterize toxicity. If no patients experience dose-limiting toxicity, dose escalation will occur. If 1 patient has a dose limiting toxicity, 3 additional patients will be enrolled at that dose. If fewer than 2 of 6 patients experiences dose limiting toxicity, then the next highest dose level will be used for the subsequent cohort of 3 patients. If at any dose level two or more of the six patients experience a dose limiting toxicity, 3 additional patients will be treated at the previous dose level.

  Course 1

Secondary Outcomes (2)

• Pharmacokinetics and cellular pharmacodynamics of alvocidib administered in this schedule

  Baseline and day 1

• Complete response (CR) and overall response rate (CR and partial response) of alvocidib in patients with previously-treated CLL

  Baseline, every 2 courses, at 2 months and then every 3 months for 5 years after completion of study treatment

Study Arms (1)

Treatment (chemotherapy)

EXPERIMENTAL

Patients receive alvocidib 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.

Drug: alvocidib; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

alvocidib DRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275

Treatment (chemotherapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of 1 of the following:
• B-cell chronic lymphocytic leukemia (CLL)
• Small lymphocytic lymphoma (SLL)
• Must have received 1-3 prior therapies for CLL
• Completed therapy 2-12 months ago
• Prior therapy must have led to a partial response or greater
• No evidence of progressive disease
• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,000/mm³
• WBC ≤ 5,000/mm³
• Platelet count ≥ 50,000/mm³
• Cytopenia allowed
• Creatinine \< 2.0 mg/dL
• Bilirubin ≤ 1.5 times normal (unless due to Gilbert's disease or hemolysis)
• AST ≤ 2 times normal (unless due to hemolysis)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Awan FT, Jones JA, Maddocks K, Poi M, Grever MR, Johnson A, Byrd JC, Andritsos LA. A phase 1 clinical trial of flavopiridol consolidation in chronic lymphocytic leukemia patients following chemoimmunotherapy. Ann Hematol. 2016 Jun;95(7):1137-43. doi: 10.1007/s00277-016-2683-1. Epub 2016 Apr 27.

  PMID: 27118540 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

alvocidib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leslie Andritsos

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 15, 2006
• Study Start: September 1, 2006
• Primary Completion: November 1, 2012
• Last Updated: July 2, 2013

Record last verified: 2013-07

Locations

US (1)