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B-cell Chronic Lymphocytic LeukemiaPhase 1NCT01292135

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

A Phase 1 study testing PCI-32765 in people with B-cell Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Pharmacyclics LLC. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PCI-32765
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
6 sitesUnited States
Study dates
Feb 2011to May 2013
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of < 6 months
  • 1 to 3 prior treatment regimens for CLL/SLL
  • ECOG performance status of ≤ 1
  • ≥ 18 years of age
  • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
  • 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)

Who cannot join

  • 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
  • Radio- or toxin-conjugated antibody therapy within 10 weeks of first dose of study drug
  • Concomitant use of medicines known to cause QT prolongation or torsades de pointes
  • 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
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Dana Farber Cancer Center

    Boston, Massachusetts, 02115

  • MD Anderson

    Houston, Texas, 77030

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • CLL Research and Treatment Program

    New Hyde Park, New York, 11042

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Phase 1b, Multicenter, Open-label, Parallel-group Safety Study of a Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI 32765, in Combination With Chemotherapy in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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).

Read the detailed description

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).

Being tested
PCI-32765
Keywords
Lymphoma, B-Cell, Leukemia, Lymphoid, Leukemia, B-Cell, Bruton's Tyrosine Kinase
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Leukemia, Lymphoid, Leukemia, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCI-32765Drug

    420 mg daily

Study groups in NCT01292135
Study groupRoleWhat they receive
PCI-32765 plus fludarabine/cyclophosphamide/rituximab (FCR)ExperimentalNot described
Receives: Drug: PCI-32765
PCI-32765 plus bendamustine/rituximab (BR)ExperimentalNot described
Receives: Drug: PCI-32765

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Prolonged Hematologic Toxicity Started in Cycle 1

    Measured: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.

Secondary outcomes (6)

  1. Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib

    Measured: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.

  2. Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0

    Measured: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.

  3. Overall Incidence of Serious Adverse Events (SAEs)

    Measured: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.

  4. Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR])

    Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. Assessment of response to treatment will be done every 2 cycles for the first 6 months and then every 3 months thereafter until disease progression or prior to the administration of a new anticancer therapy and at follow-up visits.

    Measured: From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.

  5. Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline

    Measured: From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.

  6. Progression Free Survival Rate at 12 Months

    Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.

    Measured: From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionNov 2012
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01292135
Sponsor's protocol ID
PCYC-1108-CA
Other IDs
PCI-32765
Status last verified
Jul 2014
First submitted
2 Feb 2011
Last updated
24 Jul 2014
Data monitoring committee
No

Publications

  • Brown JR, Barrientos JC, Barr PM, Flinn IW, Burger JA, Tran A, Clow F, James DF, Graef T, Friedberg JW, Rai K, O'Brien S. The Bruton tyrosine kinase inhibitor ibrutinib with chemoimmunotherapy in patients with chronic lymphocytic leukemia. Blood. 2015 May 7;125(19):2915-22. doi: 10.1182/blood-2014-09-585869. Epub 2015 Mar 9.

    PubMed 25755291

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PCI-32765 in people with B-cell Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Pharmacyclics LLC. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Prolonged Hematologic Toxicity Started in Cycle 1 (time frame: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01292135, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.

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