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LymphomaPhase 2NCT00904722

Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma

A Phase 2 study testing CT-011 and Rituximab in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site 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 goal of this clinical research study is to learn if the combination of the immunotherapy drugs, CT-011 and rituximab, can help control follicular lymphoma. The safety of this drug combination will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
CT-011 and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Jan 2010to Apr 2015
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

  • Patients with histologic proof of follicular lymphoma grade 1 or grade 2 relapsing after at least 1 but no more than 4 prior systemic therapies.Patients may have had prior local radiation therapy in addition to up to 4 prior systemic therapies. History of total body irradiation will be considered as prior systemic therapy.
  • If patient received prior rituximab-based therapy, should have rituximab sensitive disease defined as a complete or partial response of at least 6 months duration with the rituximab-based regimen.
  • Patients must be >= 18 years of age.
  • Should have measurable (>= 1.5 cm) disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • At least 4 weeks from last chemotherapy, immunotherapy, radiation therapy, monoclonal antibody therapy, or experimental therapy and must have recovered from acute toxic effects of prior therapy.
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  • Absolute neutrophil count >= 1.5 × 10^9/L.
  • Platelets >= 50 × 10^9/L.
  • Absolute lymphocyte count >= 0.6 × 10^9/L.
  • Adequate renal function with creatinine <= 1.5 × the upper limit of normal (ULN).
  • Adequate hepatic function with total bilirubin <= 1.5 mg/dL; AST and ALT <= 2.5 × ULN.
  • Women of child-bearing potential (i.e., woman has not been naturally postmenopausal for at least 24 consecutive months or not surgically sterile) and sexually active men must agree to use 2 acceptable contraceptive methods during this study. One of the 2 methods of birth control must be a condom. Acceptable methods of birth control in combination with condoms include diaphragm, birth control pills, injections, intrauterine device, and/or under-the-skin implants. Men and women must agree to maintain effective contraception for up to 3 months after the last dose of drug is administered.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

Who cannot join

  • Patients positive for HIV, hepatitis B surface antigen, or hepatitis C antibody.
  • Patients requiring concurrent immunosuppressive therapy are excluded. Inhaled or topical steroids for treating mild to moderate respiratory illnesses, allergies, skin rashes or ocular inflammations are allowed.
  • History of central nervous system (CNS) lymphoma.
  • Active or history of autoimmune disease except Hashimoto's thyroiditis. Patients with type I diabetes mellitus are excluded.
  • Active infection or other serious intercurrent medical illness
  • New York Heart Association Class III or IV disease.
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  • Pregnant or nursing.
  • History of allogeneic stem cell transplantation.
  • Other concurrent chemotherapy, radiotherapy, immunotherapy, or investigational therapy
  • Any other malignancy except basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ treated with curative intent. Any cancer from which the patient has been disease free for at least 5 years is permissible.
  • Any underlying medical condition which, in the Principal Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma

The goal of this clinical research study is to learn if the combination of the immunotherapy drugs, CT-011 and rituximab, can help control follicular lymphoma. The safety of this drug combination will also be studied.

Read the detailed description

The Study Drugs:

Rituximab is designed to attach to lymphoma cells, which may cause them to die.

CT-011 is designed to strengthen the immune system against cancer, possibly helping the immune cells kill the lymphoma cells better.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive an infusion of CT-011 every 4 weeks for a total of 4 infusions. The first infusion will take at least 2 hours and will be given through a needle in your vein. Later infusions will take at least 1 hour. You must stay at the hospital for 2 hours after each infusion. If the lymphoma remains stable or is shrinking after 4 infusions of CT-011, you may receive 8 additional infusions of CT-011 every 4 weeks, for a total of 12 infusions.

You will receive rituximab as an infusion through a needle in your vein once a week for a total of 4 infusions. The first infusion of rituximab will begin about 17 days after the first infusion of CT-011. Each rituximab infusion will be given over 4-8 hours.

You will be watched carefully before, during, and after each CT-011 or rituximab infusion in case you experience any side effects to the drug. You will be given Benadryl (diphenhydramine) and Tylenol (acetaminophen) about 30 to 60 minutes before each infusion in order to lower the risk of possible side effects. If the doctor thinks it is needed, you may also be given other drugs such as hydrocortisone or prednisone (also known as corticosteroids) to help lower the risk of possible side effects. If the side effects become intolerable, and the doctor thinks it is necessary, the infusion may be stopped for a short time or stopped completely.

Study Visits:

The following tests will be performed at your scheduled study visits.

Within 30 days before the first infusion of study drug (up to 2 weeks after the screening tests are complete):

  • Blood (about 4 ½ tablespoons) will be drawn for research tests designed to study the function of immune cells in your body.
  • Up to 5 needle biopsies (mandatory) will be collected from an enlarged lymph node to collect tumor tissue for research tests. To collect needle biopsies, the area of the tumor is numbed with anesthetic, and a small amount of tumor tissue is withdrawn using a needle.

Blood (about 1 teaspoon each time) will be drawn for research tests to check the levels of CT-011 in the blood and measure how your immune system responds to the drug. These will be drawn right after and then 2 hours after each infusion of CT-011, and on Days 7, 24, 31, 38, and 43.

About 24 hours after the first CT-011 infusion:

-Blood (about 2 ½ tablespoons) will be drawn for research tests to learn if the study drug activates the immune cells.

Before the first rituximab infusion:

  • Your medical history will be recorded.
  • You will have a physical exam.
  • You will have an ECG.
  • Blood (about 1 tablespoon) will be drawn for routine tests.
  • Blood (about 2 ½ tablespoons) will be drawn for research tests to learn if the study drug activates the immune cells longer than 2 weeks.

Before the second, third, and fourth CT-011 infusion:

  • Your medical history will be recorded.
  • You will have a physical exam.
  • You will have an ECG.
  • Blood (about 1 tablespoon) will be drawn for routine tests.
  • Blood (about 2 ½ tablespoons) will be drawn for immune-response research tests.

Before the third CT-011 infusion:

  • You will have x-rays and CT scans of the neck, chest, abdomen, and pelvis to check the disease status. You may also have a PET scan if your doctor thinks it is needed.
  • If your bone marrow was affected by the lymphoma before starting this study, you will have 2 bone marrow biopsies and 1 bone marrow aspirate collected, to check the disease status.

About 4 weeks after the fourth infusion of CT-011:

  • Your medical history will be recorded.
  • You will have a physical exam.
  • You will have an ECG.
  • Blood (about 1 tablespoon) will be drawn for routine tests.
  • You will have x-rays and CT scans of the neck, chest, abdomen, and pelvis to check the status of your lymphoma. You may also have a PET scan if your doctor thinks it is needed.
  • If your bone marrow was affected by lymphoma before starting therapy, you will have 2 bone marrow biopsies and 1 bone marrow aspirate collected to check the status of the disease.
  • Blood (about 2 ½ tablespoons) will be drawn for immune-response research studies.

Before CT-011 infusions 5 through 12:

  • Your medical history will be recorded.
  • You will have a physical exam.
  • Blood (about 1 tablespoon) will be drawn for routine tests.

Length of Study:

You may continue receiving CT-011 for up to a total of 12 infusions. You will be taken off study if you have intolerable side effects or the disease gets worse.

Long-Term Follow-Up:

You will be asked to return to the clinic for the following long-term follow-up tests:

About every 3 months after you complete 4 infusions of CT-011:

  • Your medical history will be recorded.
  • You will have a physical exam.
  • You will have an ECG at the final study completion visit.
  • Blood (about 1 tablespoon) will be drawn for routine tests.
  • You will have x-rays and CT scans of the neck, chest, abdomen, and pelvis to check the disease status.

If your CT scans show that the lymphoma has gone away completely during the above visits, you may also have a PET scan and 2 bone marrow biopsies and 1 bone marrow aspirate collected to confirm the disease status.

At 3, 6, 9, and 12 months after the end of treatment:

-Blood (about 2 ½ tablespoons each time) will be drawn for immune-response research studies.

This is an investigational study. Rituximab is FDA approved and commercially available for the treatment of non-Hodgkin's lymphomas, including follicular lymphoma.

CT-011 is not FDA approved or commercially available. At this time, this drug is being used in research only.

Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions
Lymphoma
Being tested
CT-011, Rituximab
Keywords
Follicular lymphoma, Immunotherapy, CT-011, Monoclonal Antibody CT-011, Rituximab, Rituxan
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

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

  • CT-011Drug

    Also called Monoclonal Antibody CT-011

    Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days).

  • RituximabDrug

    Also called Rituxan

    Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).

Study groups in NCT00904722
Study groupRoleWhat they receive
CT-011 in combination with RituximabExperimentalCombination of the immunotherapy drugs, CT-011 and rituximab.
Receives: Drug: CT-011; Drug: Rituximab

What is being measured

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

  1. Overall Response Rate

    Overall response (OR) rate defined as complete response (CR) + partial response (PR). CR: Complete disappearance of all detectable clinical evidence of disease and symptoms if present before therapy. If a PET scan was positive before therapy, a post-treatment residual mass of any size was deemed a complete response provided that it was PET negative. If response was determined by CT scan criteria, lymph nodes that regressed to less than 1·5 cm were deemed to be complete response. The spleen and/or liver, if considered enlarged before therapy should not be palpable on physical examination and be considered normal size by imaging studies, and nodules related to lymphoma should disappear. PR: At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥ 50% in their SPD. No new sites of disease should be observed.

    Measured: Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.

Secondary outcomes (1)

  1. Progression-Free Survival

    Progression-Free Survival (PFS) was measured from enrollment to disease progression or recurrence or death from any cause.

    Measured: Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.

Timeline

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

  1. First posted20 May 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionApr 2015
  4. Study completionApr 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00904722
Sponsor's protocol ID
2009-0163
Other IDs
NCI-2011-03225
Status last verified
Apr 2016
First submitted
18 May 2009
Last updated
3 Jun 2016
Data monitoring committee
Yes

Publications

  • Westin JR, Chu F, Zhang M, Fayad LE, Kwak LW, Fowler N, Romaguera J, Hagemeister F, Fanale M, Samaniego F, Feng L, Baladandayuthapani V, Wang Z, Ma W, Gao Y, Wallace M, Vence LM, Radvanyi L, Muzzafar T, Rotem-Yehudar R, Davis RE, Neelapu SS. Safety and activity of PD1 blockade by pidilizumab in combination with rituximab in patients with relapsed follicular lymphoma: a single group, open-label, phase 2 trial. Lancet Oncol. 2014 Jan;15(1):69-77. doi: 10.1016/S1470-2045(13)70551-5. Epub 2013 Dec 11.

    PubMed 24332512

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CT-011 and Rituximab in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site 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 11 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 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 Jun 2016). 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 (time frame: Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.). 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 NCT00904722, 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 3 Jun 2016.

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