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Chronic Lymphocytic Leukemia (CLL)Phase 1NCT00710528

Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies

A Phase 1 study testing CAL-101 in people with Chronic Lymphocytic Leukemia (CLL) and Lymphoma, Non-Hodgkin (NHL), run by Gilead Sciences at 9 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 determine the dose that can be safely given to see what effect it may have on your cancer and to determine how the drug is distributed in the body. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CAL-101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
9 sitesUnited States
Study dates
Jun 2008to Aug 2012
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Age > or = 18.
  • Has relapsed or refractory disease as defined by the following:
  • CLL - refractory to or relapsed after at least 2 prior therapies, including fludarabine, alone or in combination. Patients should not be eligible for transplantation (patients who are candidates for transplantation and have declined transplantation are eligible for this study).
  • B-cell NHL - refractory to or relapsed after at least 1 prior chemotherapy regimen and having received rituximab as a single agent or in combination with other therapies.
  • AML - refractory to or relapsed after at least 1 cycle of induction chemotherapy. Patients over the age of 70 who are not appropriate candidates for chemotherapy are eligible for this study.
  • MM - refractory to or relapsed after at least 2 prior chemotherapy regimens, including bortezomib and thalidomide or lenalidomide (except if the drug is contraindicated in a patient then this requirement is waived).
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  • Disease status requirement:
  • For CLL patients, symptomatic disease that mandate treatment.
  • For B-cell NHL patients, has measurable disease by CT scan.
  • For AML patients, has > 10% blasts in the bone marrow for refractory or relapsed disease and > 20% blasts in the bone marrow if no prior chemotherapy.
  • For MM patients, has measurable disease defined by at least 1 of the following 3 measurements: serum M-protein > or = to 1 g/dL, urine M-protein > or = to 200 mg/24 h, or serum free light chain (FLC) assay with involved FLC level > or = to 10 mg/dL provided serum FLC ratio is abnormal.
  • WHO performance status of ≤ 2.
  • For men and women of child-bearing potential, willing to use adequate contraception (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study.
  • Is able to provide written informed consent.

Who cannot join

  • Had radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 4-weeks prior to screening.
  • For CLL or NHL patients, had treatment with a short course of corticosteroids for symptom relief within 1-week prior to screening.
  • Had alemtuzumab therapy within 12-weeks prior to screening.
  • For AML patients, had treatment with hydroxyurea within 1-week prior to screening.
  • Is pregnant or nursing.
  • Has significant, ongoing co-morbid conditions which would preclude safe delivery of the study drug.
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  • Has had a transplant with current active graft-versus-host-disease.
  • Has known active central nervous system involvement of the malignancy.
  • Has active, serious infection requiring systemic therapy. Patients may receive prophylactic antibiotics and antiviral therapy at the discretion of the treating physician.
  • Has significant renal or liver dysfunction.
  • Has severe thrombocytopenia requiring platelet transfusion support, unless the diagnosis is AML.
  • Has a positive test for human immunodeficiency virus (HIV) antibodies.
  • Has active hepatitis B or C. Patients with serologic evidence of prior exposure are eligible.
  • Has poorly controlled diabetes mellitus.
  • Has taken a medication that is a potent inhibitor or inducer of cytochrome P450 3A4 within 1-week prior to screening.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

    Baltimore, Maryland, 21231

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • University of Wisconsin

    Madison, Wisconsin, 53792-5156

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Weill Medical College of Cornell

    New York, New York, 10021

  • Stanford Cancer Center

    Palo Alto, California, 94304-5548

  • Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients With Select, Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to determine the dose that can be safely given to see what effect it may have on your cancer and to determine how the drug is distributed in the body.

Read the detailed description

A Phase 1, sequential dose escalation followed by cohort expansion study of CAL-101, an oral inhibitor of PI3K delta, in patients with relapsed or refractory CLL, select B-cell NHL and AML.

Being tested
CAL-101
Keywords
CLL, NHL, AML, MM, Phosphatidylinositol 3-kinase
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Lymphoma, Non-Hodgkin, Leukemia, Myeloid, Acute, Multiple Myeloma

What participants receive

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

  • CAL-101Drug

    CAL-101 50, 100, 150, 200, 350 mg capsules BID for 28 days CAL-101 150, 300 mg QD for 28 days CAL-101 150 mg BID 3 weeks on 1 week off for 28 days

Study groups in NCT00710528
Study groupRoleWhat they receive
one armExperimentalNot described
Receives: Drug: CAL-101

What is being measured

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

  1. To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies.

    Measured: 28 days

Secondary outcomes (1)

  1. To evaluate the pharmacokinetic parameters, pharmacodynamic effects and clinical response rate following CAL-101 treatment in patients with hematologic malignancies.

    Measured: 28 Days

Timeline

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

  1. First posted4 Jul 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionDec 2011
  4. Study completionAug 2012

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00710528
Sponsor's protocol ID
101-02
Status last verified
Aug 2012
First submitted
1 Jul 2008
Last updated
31 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • Kahl BS, Spurgeon SE, Furman RR, Flinn IW, Coutre SE, Brown JR, Benson DM, Byrd JC, Peterman S, Cho Y, Yu A, Godfrey WR, Wagner-Johnston ND. A phase 1 study of the PI3Kdelta inhibitor idelalisib in patients with relapsed/refractory mantle cell lymphoma (MCL). Blood. 2014 May 29;123(22):3398-405. doi: 10.1182/blood-2013-11-537555. Epub 2014 Mar 10.

    PubMed 24615778

  • Brown JR, Byrd JC, Coutre SE, Benson DM, Flinn IW, Wagner-Johnston ND, Spurgeon SE, Kahl BS, Bello C, Webb HK, Johnson DM, Peterman S, Li D, Jahn TM, Lannutti BJ, Ulrich RG, Yu AS, Miller LL, Furman RR. Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110delta, for relapsed/refractory chronic lymphocytic leukemia. Blood. 2014 May 29;123(22):3390-7. doi: 10.1182/blood-2013-11-535047. Epub 2014 Mar 10.

    PubMed 24615777

  • Flinn IW, Kahl BS, Leonard JP, Furman RR, Brown JR, Byrd JC, Wagner-Johnston ND, Coutre SE, Benson DM, Peterman S, Cho Y, Webb HK, Johnson DM, Yu AS, Ulrich RG, Godfrey WR, Miller LL, Spurgeon SE. Idelalisib, a selective inhibitor of phosphatidylinositol 3-kinase-delta, as therapy for previously treated indolent non-Hodgkin lymphoma. Blood. 2014 May 29;123(22):3406-13. doi: 10.1182/blood-2013-11-538546. Epub 2014 Mar 10.

    PubMed 24615776

  • Stevenson FK, Krysov S, Davies AJ, Steele AJ, Packham G. B-cell receptor signaling in chronic lymphocytic leukemia. Blood. 2011 Oct 20;118(16):4313-20. doi: 10.1182/blood-2011-06-338855. Epub 2011 Aug 3.

    PubMed 21816833

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAL-101 in people with Chronic Lymphocytic Leukemia (CLL) and Lymphoma, Non-Hodgkin (NHL), run by Gilead Sciences at 9 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 14 inclusion and 15 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 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies. (time frame: 28 days). 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 NCT00710528, which also lists 4 linked publications.

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 31 Aug 2012.

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