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CancerPhase 1NCT01691807

Drug-drug Interaction Study of Ofatumumab With Bendamustine in Subjects With Indolent B-cell Non-Hodgkin's Lymphoma

A Phase 1 study testing ofatumumab and bendamustine in people with Cancer, run by Novartis Pharmaceuticals at 5 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 evaluate the potential drug-drug interactions between ofatumumab and bendamustine in subjects with previously untreated or relapsed indolent B-cell non-Hodgkin's lymphoma (NHL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
ofatumumab and bendamustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesUnited States
Study dates
Jan 2013to Dec 2015
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

  • Subjects with previously untreated or relapsed indolent B-cell NHL requiring treatment. Indolent NHL is defined as small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), and follicular lymphoma (FL); grades 1, 2, and 3A, defined according to WHO guidelines. Tumor verified to be CD20+ positive from a previous or current lymph node biopsy.
  • At least 4 weeks after previous anti-cancer chemotherapy, or radiotherapy treatment.
  • At least 12 weeks after previous anti-CD20 radioimmunotherapy, anti-CD20 antibody treatment, and non-anti-CD20 monoclonal antibody treatment.
  • Subjects who give consent to this study participation and sign the informed consent form.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
  • Age greater than or equal to 18 years at informed consent.
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  • A female subject is eligible to participate if she is of Non-childbearing potential or required to use a contraception method.
  • Male subjects with female partners of child-bearing potential must agree to use a contraception method.
  • Subjects must agree to use contraception until 12 months after the last dose of study drug.

Who cannot join

  • Subjects who failed to achieve a complete remission (CR) or partial remission (PR) or progressed within 6 months of last rituximab-containing therapy
  • Previous treatment with ofatumumab.
  • Prior bendamustine treatment not resulting in a complete remission and partial remission for at least 6 months.
  • Previous allogeneic stem cell transplant.
  • Previous autologous stem cell transplant.
  • High dose steroids greater than or equal to 100 mg prednisone/day (or equivalent) for greater than or equal to 7 consecutive days, given as concomitant medication, within 3 months prior to randomization. No more than 20 mg prednisone or equivalent daily at the time of randomization.
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  • Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma as verified by biopsy confirmation.
  • Known central nervous system involvement by NHL.
  • Other past or current malignancy. Subjects who have been free of malignancy for at least 2 years, or have a history of definitively treated non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligible.
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, and active Hepatitis B or C. Prophylactic antibiotics to prevent recurrent of a prior infection (such as shingles, sinusitis or upper respiratory infection) is allowed.
  • Clinically significant cardiac disease as judged by the investigator, including unstable angina, acute myocardial infarction within 6 months of randomization, and uncontrolled congestive heart failure (CHF) or arrhythmia. Patients with a history of CHF or arrhythmia are eligible if their cardiac disease is well controlled on a stable medical regimen.
  • History of significant cerebrovascular disease or event with significant symptoms or sequelae (as judged by the investigator).
  • Significant concurrent, uncontrolled medical condition that in the opinion of the investigator contraindicates participation this study.
  • Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HBsAg). In addition, if negative for HBsAg but Hepatitis B core antibody (HBcAb) positive (regardless of Hepatitis B surface antibody [HBsAb] status), a HB DNA test will be performed and if positive the subject will be excluded. If HBV DNA is negative, the subject may be included but must undergo Hepatitis B virus (HBV) DNA monitoring (see Section 7.7.5). Prophylactic antiviral therapy may be initiated at the discretion of the investigator.
  • Current active liver or biliary disease (subjects with Gilbert's syndrome or asymptomatic gallstones, liver metastases related to indolent NHL or otherwise stable chronic liver disease per investigator assessment, are eligible).
  • Known human immunodeficiency virus (HIV) positive.
  • Screening laboratory values:
  • platelets < 100 x 109/L (unless due to lymphoma involvement of the bone marrow)
  • neutrophils < 1.5 x 109/L (unless due to lymphoma involvement of the bone marrow)
  • serum creatinine > 1.5 times the institution's upper limit of normal (ULN); subjects with a serum creatinine > 1.5 ULN will be eligible if the calculated creatinine clearance [Cockcroft, 1976] or creatinine clearance from a 24-hour urine collection is ≥ 40 mL/min
  • total bilirubin > 1.5 times ULN (unless due to liver involvement by lymphoma or Gilbert's syndrome)
  • transaminases > 2 times ULN
  • Known or suspected hypersensitivity to ofatumumab, bendamustine, or mannitol.
  • 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 or currently participating in any other interventional clinical study
  • Lactating women, women with a positive pregnancy test at Visit 1, or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception until 12 months after the last dose of study drug. Adequate contraception is defined in Section 8.1.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Novartis Investigative Site

    Birmingham, Alabama, 35294-3300

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Morgantown, West Virginia, 26506

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    Southaven, Mississippi, 38671

Other trials in United States

About this study

Official title: An Open-label Phase I Drug-drug Interaction Study of Ofatumumab With Bendamustine for the Treatment of Subjects With Indolent B-cell Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate the potential drug-drug interactions between ofatumumab and bendamustine in subjects with previously untreated or relapsed indolent B-cell non-Hodgkin's lymphoma (NHL).

Read the detailed description

The purpose of this study is to evaluate the potential drug-drug interactions between ofatumumab and bendamustine in subjects with previously untreated or relapsed indolent B-cell non-Hodgkin's lymphoma (NHL). Ofatumumab and bendamustine will be administered alone and in combination in a two-arm, open-label study to evaluate the pharmacokinetic profile, safety, tolerability, and efficacy of ofatumumab and bendamustine.

The primary objective of the study is to evaluate pharmacokinetic parameters of ofatumumab and bendamustine alone and in combination. Secondary objectives are to evaluate safety, tolerability, and efficacy.

Conditions
Cancer
Being tested
ofatumumab, bendamustine
Keywords
Non-Hodgkin's Lymphoma, drug-drug interaction, ofatumumab, bendamustine
Medical subject headings
Neoplasms, Lymphoma, Non-Hodgkin

What participants receive

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

  • ofatumumabDrug

    treatment for NHL

  • bendamustineDrug

    treatment for NHL

Study groups in NCT01691807
Study groupRoleWhat they receive
Arm AExperimentalbendamustine and ofatumumab treatment of NHL
Receives: Drug: ofatumumab; Drug: bendamustine
Arm BExperimentalofatumumab only treatment of NHL
Receives: Drug: ofatumumab

What is being measured

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

  1. Pharmacokinetic measures of Cmax and Area Under the Curve by analysis of blood samples for the amount of each drug present at different timepoints.

    The amount of ofatumumab and bendamustine in the blood will be measured when given individually or together to obtain Cmax and Area Under the Curve. Bendamustine levels will be collected at Cycles 1 and 2: Predose, 0.25, 0.5, 0.75, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours. Ofatumumab will be collected at Cycle 4: Predose, end of infusion, then 1, 2, 24, and 72 hours after end of infusion, then once each on Days 8, 15, and 22.

    Measured: 4 months

Secondary outcomes (2)

  1. Changes in vital signs and the number adverse events

    Changes in vital signs will be measured during the entire study to determine any effect on the subjects health. Also the recording of all adverse events that occur during the study will be collected for analysis.

    Measured: 14 months

  2. Measure the extent of the disease by CT scan or flow cytometry analysis

    Dimension measurement assessments by CT scan of disease will be collected at Screen, Cycle 5, 3 month follow up visit, and 6 month follow up visit. Flow cytometry measurements will be collected at Screen and Weeks 1, 2, 5, 13, 21, 41, and 53.

    Measured: 14 months

Timeline

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

  1. First posted25 Sep 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01691807
Sponsor's protocol ID
113603
Status last verified
Feb 2018
First submitted
13 Sep 2012
Last updated
28 Feb 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ofatumumab and bendamustine in people with Cancer, run by Novartis Pharmaceuticals at 5 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 9 inclusion and 25 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Pharmacokinetic measures of Cmax and Area Under the Curve by analysis of blood samples for the amount of each drug present at different timepoints. (time frame: 4 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 NCT01691807.

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 28 Feb 2018.

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