Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).

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Detailed Description

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This is a Phase 1b, open-label, parallel-group, nonrandomized, multicenter study of PCI 32765 420 mg once daily oral (PO) administration in combination with 2 different chemotherapy regimens in subjects with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Conditions

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B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCI-32765 plus fludarabine/cyclophosphamide/rituximab (FCR)

Group Type EXPERIMENTAL

PCI-32765

Intervention Type DRUG

420 mg daily

PCI-32765 plus bendamustine/rituximab (BR)

Group Type EXPERIMENTAL

PCI-32765

Intervention Type DRUG

420 mg daily

Interventions

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PCI-32765

420 mg daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histologically confirmed CLL or SLL and satisfying at least 1 of the following criteria for requiring treatment:

* Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
* Anemia (\<11 g/dL) or thrombocytopenia (\<100,000/μL) due to bone marrow involvement
* Presence of unintentional weight loss \> 10% over the preceding 6 months
* NCI CTCAE Grade 2 or 3 fatigue
* Fevers \> 100.5° or night sweats for \> 2 weeks without evidence of infection
* Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of \< 6 months
2. 1 to 3 prior treatment regimens for CLL/SLL
3. ECOG performance status of ≤ 1
4. ≥ 18 years of age
5. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
6. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)

Exclusion Criteria

1. Any chemotherapy, therapeutic antineoplastic antibodies (not including radio- or toxin immunoconjugates), radiation therapy, or experimental antineoplastic therapy within 4 weeks of first dose of study drug
2. Radio- or toxin-conjugated antibody therapy within 10 weeks of first dose of study drug
3. Concomitant use of medicines known to cause QT prolongation or torsades de pointes
4. Transformed lymphoma or Richter's transformation Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
5. Any of the following laboratory abnormalities: oAbsolute neutrophil count (ANC) \< 1000 cells/mm3 (1.0 x 109/L) oPlatelet count \< 50,000/mm3 (50 x 109/L) oSerum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) oCreatinine \> 2.0 x ULN or creatinine clearance \< 40 mL/min

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No