A Phase 2 interventional study of Pentostatin and Cyclophosphamide in Chronic Lymphocytic Leukemia, sponsored by Niguarda Hospital. Completed at 12 sites in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-12-28.
Sponsored by Niguarda Hospital · Phase 2, Interventional, and Treatment
This is a phase II multicenter, non-comparative, open label study in older previously untreated Chronic Lymphocytic Leukaemia patients, requiring therapy, aimed at defining the efficacy profile (ORR, CRR and TTP) of pentostatin and cyclophosphamide given in combination with Ofatumumab (PCO).
Chronic lymphocytic leukemia (CLL) is the most common of the chronic lymphoid leukemias, comprising 30% of all adult leukemias. The majority of CLL patients are of advanced age. Currently, immunochemotherapy with Rituximab, Fludarabine and Cyclophosphamide (RFC) is the standard of care in previously untreated patients with CLL requiring treatment. The combination of Pentostatin and Cyclophosphamide has generated excellent clinical response rates in pretreated B-CLL patients. Early data on the use of Ofatumumab as a single agent in Fludarabine-refractory CLL patients have been reported. Given the reported efficacy of chemo-immunotherapy combinations in CLL and the promising activity and toxicity profile of Pentostatin combinations, we designed a trial of Pentostatin, Cyclophosphamide, and Ofatumumab for previously untreated older patients with CLL. The aim is improving efficacy, in Rituximab resistant CLL, and toxicity considering the good profile of tolerability showed using Ofatumumab as single agent.
5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 47 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →Niguarda Hospital is the lead sponsor of 66 studies on the registry; 28 are open to participants now.
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Diagnosis of B-CLL defined by:
A minimum of any one of the following disease-related symptoms must be present:
Exclusion Criteria:
Screening laboratory values:
Subjects will receive up to 6 cycles of pentostatin, cyclophosphamide, and ofatumumab given every 21 days (+/- 4 days).
Drug: Pentostatin · Drug: Cyclophosphamide · Drug: Ofatumumab
Lyophilized powder for intravenous administration.
Also known as: Nipent 10 mg
IV
Liquid concentrate for solution for infusion.
Also known as: Arzerra 100 mg
Overall Response Rate (ORR)
To assess the overall response rate (ORR) using pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL requiring therapy.
Time frame: 2 months after the last dose received (End of treatment period)
Adverse Events according to CTCAE, Version 3.0 NCI CTCAE
To monitor and assess toxicity of pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL.
Time frame: From informed consent signed through to 28 days after the last study drug administration
Complete Response Rate (CRR)
To assess the complete response of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab
Time frame: Baseline, at cycle 3 and 2 months after the last dose received
Minimal Residual Disease (MRD)
To determine the proportion of patients who achieve a minimal residual disease (MRD) negative state as assessed by flow cytometry.It will be assessed only in patients responding to PCO treatment.
Time frame: Every 3 months from the last dose of treatment up to 2 years follow up.
Progression-Free Survival
To determine the progression-free survival in CLL patients treated with pentostatin,cyclophosphamide, and ofatumumab.
Time frame: Measured as the time from inclusion in the trial to disease progression or death, assessed up to 2 years
Overall Survival (OS)
To assess overall survival (OS) of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab
Time frame: Measured as the time from inclusion in the trial until death from any cause, assessed up to 2 years of follow up
Time To Progression (TTP)
To assess the time-to-progression (TTP) of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab
Time frame: Measured as the time from inclusion in the trial until disease progression or death, assessed up to 2 years
Genetic analysis by Fish
To determine if cytogenetic abnormalities identified by FISH, relate to response to PCO therapy.
Time frame: Baseline, 2 months after the last dose received and at month 12 and 24 during follow up
Ofatumumab pharmacokinetics parameter
To assess ofatumumab pharmacokinetic parameters
Time frame: Cycle1: Day 1, 2, 3, 8, 9, 15. Cycles 2-5: Day 1, 2, 3, 8,15. Cycle 6: Day 1, 2, 3, 8, 15, 21
IgVH mutation status
To determine if IgVH mutation status relate to response to PCO therapy
Time frame: Baseline, 2 months after the last dose received and at month 12 and 24 during follow up
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Niguarda Hospital