Clinical trial · Interventional
Alvocidib in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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
NCT00377104CI-TRIAL-00011175terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Contiguous Stage II Small Lymphocytic Lymphoma | — | UNRESOLVED | — |
| Noncontiguous Stage II Small Lymphocytic Lymphoma | — | UNRESOLVED | — |
| Stage I Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage II Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage III Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage III Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | CURATED_BROADER | 0.78 |
| Stage I Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy)
- description
- 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.
- interventionNames
- Drug: alvocidib
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- 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
- timeFrame
- Day 1, every 2 courses, at 2 months and then every 3 months for 5 years after completion of study treatment
- description
- Assessed utilizing the NCI Common Terminology Criteria for Adverse Events version 3.0.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * No secondary malignancy or other disease that would limit survival to \< 2 years * No history of inflammatory bowel disease unless inactive for \> 2 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * See Disease Characteristics * No other concurrent chemotherapy * No concurrent radiotherapy * No concurrent dexamethasone or other corticosteroid-based antiemetics * No concurrent chronic corticosteroid therapy * No other concurrent hormonal therapy except for the following: * Steroids for new adrenal failure * Hormones for nondisease-related conditions (e.g., insulin for diabetes)
References
Publications (1)
- DERIVEDAwan 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