Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Chemo-Free combo shows promise for older CLL patients

NCT ID NCT02315768

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a combination of two drugs, ibrutinib and obinutuzumab, in 32 older adults (65+) or those with health issues who had untreated chronic lymphocytic leukemia (CLL). The goal was to see if the combo could safely reduce cancer cells without using chemotherapy. The trial looked at side effects, dose limits, and how well the cancer responded.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ibrutinib and obinutuzumab (two drugs taken together)
What this could lead to
If successful, this combination could offer a chemotherapy-free treatment option for older or frail patients with chronic lymphocytic leukemia (CLL).
What could go wrong
This was an early-phase trial with only 32 participants, so results may not apply to everyone. Side effects from the drugs are possible, and long-term benefits are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

32 people

The number who actually took part.

Started

Aug 2015

Finished

Apr 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of CLL 2. Indication for treatment as defined by the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) Guidelines 3. No previous treatment for CLL 4. Males and females 65 years of age and older. Subjects under 65 years of age that meet any of the following criteria: A. Documented refusal to be treated with chemotherapy agents B. Subjects that are not candidates for treatment with chemotherapy based on poor performance status (ECOG g\>= 2), Cumulative Illness Rating Scale (CIRS score) \>= 6 or creatinine clearance less than 70 mL/min 5. Adequate hematologic, hepatic, and renal function 6. Anticipated survival of at least 6 months 7. Effective contraception is required while receiving Ibrutinib in combination with GA101-Obinutuzumab. For women of childbearing potential and men, effective contraception is required while receiving GA101-Obinutuzumab and for 365 days (12 months) after the last dose of the study drug Exclusion Criteria: 1. Pregnant or nursing women 2. Treatment with chemotherapy, monoclonal antibodies, or biological agents (e.g. lenalidomide) other than the investigational agents during the time of participation in this trial 3. Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification 4. Severe or debilitating pulmonary disease 5. Participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol. 6. History of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least 2 years before trial entry and with no evidence of relapse or active cancer. 7. Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with HIV, human T-cell leukemia virus 1 (HTLV-1) seropositive status. 8. Evidence of active acute or chronic Hepatitis B (HBV) 9. Evidence of active Hepatitis C (HCV): subjects with positive hepatitis C serology and positive HCV RNA test 10. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy 11. Known hypersensitivity to any of the study drugs 12. Major surgery (within 4 weeks prior to the start of Cycle 1), except for procedures that are performed for diagnostic purposes 13. Vaccination with a live vaccine within 28 days of the initiation of treatment. 14. Concomitant use of warfarin or other Vitamin K antagonists 15. Requirement to receive treatment with a strong cytochrome P450 (CYP) 3A inhibitor 16. Chronic liver disease with hepatic impairment (Child-Pugh class B or C)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic lymphocytic leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UCSD Moores Cancer Center

    La Jolla, California, 92093, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.