Clinical trial · Interventional
Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
A Multicenter, Open-label, Single Arm Study of Weekly Alvocidib in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) Arising From CLL
- 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)
Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients. Primary objective is to determine overall response rate. The secondary objectives are: * to assess overall safety, * to assess duration of response, progression free survival, and overall survival. Clinical benefit and pharmacokinetics parameters are also evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alvocidib
- description
- Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles
- interventionNames
- Drug: alvocidib
Primary outcomes (1)
- measure
- Best overall objective response rate
- timeFrame
- Up to a maximum of 6 cycles
- description
- Objective Response Rate (ORR) is defined as the proportion of participants with complete response or partial response (including nodular partial response) relative to the total number of participants. Response assessment is based on evaluation of nodal disease by Computerized Tomography (CT) and National Cancer Institute Working Group 96 criteria (NCI-96) for assessment of liver, spleen, constitutional symptoms, peripheral blood (±) bone marrow.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have documentation of histologically confirmed and measurable Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) arising from CLL; * Patient must have symptomatic and progressive disease; * Patient must have received prior alkylating agent(s) and be fludarabine refractory; * Patient must have the adequate organ functions; * Patient's Eastern Cooperative Oncology Group performance (ECOG) status must be 0-2; Exclusion Criteria: * Patient with de novo PLL; * Patient with secondary malignancy that will limit survival ≤5 years; * Patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months; * Patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry; * Patient with known history of glucose-6-phosphate dehydrogenase deficiency; * Patient with autoimmune hemolytic anemia; * Patient with known Central Nervous System involvement; * Patient with active, uncontrolled serious bacterial, viral or fungal infections The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
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