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Chronic Lymphocytic LeukemiaPhase 2NCT01113632

Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 2 study testing Ofatumumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by SCRI Development Innovations, LLC at 13 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 risk of immunosuppression deters many patients from receiving fludarabine, while combination chemotherapy regimens are poorly tolerated by elderly or infirm chronic lymphocytic leukemia (CLL) patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ofatumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
13 sitesUnited States
Study dates
Jul 2010to Aug 2016
Phase
Phase 2
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

  • CD20+ B-cell chronic lymphocytic leukemia (B-CLL) or small lymphocytic lymphoma according to NCI criteria (see Appendix B).
  • Previously untreated CLL or small lymphocytic lymphoma (SLL).
  • Patients must require treatment according to NCI-Working Group guidelines (see Appendix C).
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤2 (see Appendix A).
  • Laboratory values as follows ≤7 days of initiation of treatment:
  • Creatinine <3.0 mg/dL
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  • Aspartate amino transferase (AST) or alanine amino transferase (ALT) and alkaline phosphatase (ALP) must be <3 x upper limit of normal (ULN)
  • Total bilirubin <1.5 x the institutional ULN
  • Patients must be hepatitis B sAg negative. Note: Patients who are HepB sAg negative but are HepB cAb positive (regardless of HepB sAb status) will NOT be allowed.
  • Women of childbearing potential must have a negative serum pregnancy test performed ≤7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  • Patients ≤ 65 years of age, or patients 18-64 years of age who have declined fludarabine-based regimens, are eligible.
  • Patient must be accessible for treatment and follow-up.
  • Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.

Who cannot join

  • Previous therapy for CLL/SLL. (Patients who have received steroids or IVIG for autoimmune complications of CLL are eligible).
  • Current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease, per assessment by the treating physician).
  • Active bacterial or viral infection, or infection requiring intravenous antibiotic treatment at the time of accrual.
  • Central nervous system lymphoma/CLL.
  • Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (i.e., Richters transformation).
  • History of other malignancy within 2 years of study entry which could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, low grade, early-stage, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ (DCIS) of the breast treated with curative intent, are generally eligible. These cases should be discussed with the study chair or study co-chair prior to enrollment.
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  • Patients who are HepB sAg positive and/or HepB cAb positive.
  • Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  • A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • A major surgical procedure, open biopsy, or significant traumatic injury ≤28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study.
  • Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to visit 1, whichever is longer. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • St. Louis Cancer Care

    Chesterfield, Missouri, 63017

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

  • The Ohio State University

    Columbus, Ohio, 43210

  • Florida Cancer Specialists

    Fort Myers, Florida, 34236

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Hematology-Oncology Associates of Northern NJ

    Morristown, New Jersey, 07960

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Woodlands Medical Specialists

    Pensacola, Florida, 32503

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire, 03801

  • Providence Medical Group

    Terre Haute, Indiana, 47802

  • Los Robles

    Thousand Oaks, California, 91360

Other trials in United States

About this study

Official title: Phase II Trial of Ofatumumab for Older Patients and Patients Who Refuse Fludarabine-Based Regimens With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The risk of immunosuppression deters many patients from receiving fludarabine, while combination chemotherapy regimens are poorly tolerated by elderly or infirm chronic lymphocytic leukemia (CLL) patients. Previous studies by our group and others have shown that rituximab is safe and well tolerated when used as a single agent in patients with CLL. In addition, maintenance therapy with rituximab was well tolerated by CLL patients, with probable prolongation of progression-free survival (Hainsworth et al. 2003). Based on pre clinical and clinical studies indicating possible increased efficacy of ofatumumab in patients with CLL, we wish to develop an antibody-only regimen for older patients and patients who refuse fludarabine-based regimens.

Being tested
Ofatumumab
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Ofatumumab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • OfatumumabDrug

    IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Study groups in NCT01113632
Study groupRoleWhat they receive
Ofatumumab 1000mgExperimentalOfatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks
Receives: Drug: Ofatumumab
Ofatumumab 2000mgExperimentalOfatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks
Receives: Drug: Ofatumumab

What is being measured

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

  1. Overall Response Rate (ORR)

    The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 18 months

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    To assess the overall response rate of patients with previously untreated CLL or SLL receiving ofatumumab.

    Measured: 18 months

  2. Number of Complete Responses

    The Number of Patients Who Experience a Complete Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions

    Measured: 18 Months

  3. Number of Partial Responses

    The Number of Patients Who Experience a Partial Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions

    Measured: 18 Months

  4. Safety of the Treatment Regimen

    Listing of all non-serious Adverse Events ocurring in 5% of patients or more

    Measured: 18 Months

Timeline

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

  1. First posted30 Apr 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionMar 2015
  4. Study completionAug 2016

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01113632
Sponsor's protocol ID
SCRI CLL 11
Status last verified
Aug 2016
First submitted
28 Apr 2010
Last updated
20 Sep 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ofatumumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by SCRI Development Innovations, LLC at 13 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 13 inclusion and 12 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 Jun 2015). 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?

Overall Response Rate (ORR) (time frame: 18 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 NCT01113632.

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 20 Sep 2016.

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