Obinutuzumab + HDMP for Chronic Lymphocytic Leukemia
(GA101 & HDMP Trial)

Recruiting in Palo Alto (17 mi)

Overseen byKipps Thomas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug combination for CLL patients, using Obinutuzumab and high-dose methylprednisone. It includes patients who are new to treatment and those who haven't responded to other treatments. The goal is to see if this combination can effectively target and destroy cancer cells while reducing inflammation. Obinutuzumab is a fully humanized antibody that targets specific cells and has been approved for use with other treatments in patients with previously untreated CLL.

Eligibility Criteria

This trial is for adults with Chronic Lymphocytic Leukemia who have a life expectancy of at least 6 months, can perform daily activities (ECOG <2), and have adequate kidney, liver, and blood function. It's open to those new to treatment or with previous treatments but not to pregnant women or those on recent other cancer therapies.

Inclusion Criteria

Effective contraception required for women of childbearing potential and men

Indication for treatment as defined by the IWCLL Guidelines (Hallek et al., 2008b)

Anticipated survival of at least 6 months

See 9 more

Exclusion Criteria

History of severe allergic reactions to monoclonal antibody therapy

I have had major surgery recently.

Pregnant or nursing women

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Treatment Details

Interventions

Methylprednisolone (Corticosteroid)
Obinutuzumab (Monoclonal Antibodies)

Trial OverviewThe study tests Obinutuzumab combined with high-dose Methylprednisolone in CLL patients. The hypothesis suggests this combination could be more effective than previous similar treatments. Participants will receive these drugs and their responses will be monitored.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: GA101/HDMPExperimental Treatment1 Intervention

All subjects will receive GA101 - Obinutuzumab by IV infusion for up to 6 cycles (28-day cycles) as follow: * On Cycle 1, Day 1, 100 mg GA101-obinutuzumab will be administered. * On Cycle 1, Day 2, 900 mg of GA101-obinutuzumab will be administered. * On Cycle 1, Days 8 and 15, 1,000 mg of GA101-obinutuzumab will be administered. * On Cycles 2-6, Day 1, 1,000 mg of GA101-obinutuzumab will be administered. All subjects will receive HDMP by IV infusion for up to 4 cycles (28-day cycles) as follow: •On Cycle 1-4, Days 1 to 3, 1,000 mg/m2 Methylprednisolone will be administered.

Methylprednisolone is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Medrol for: