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Corticosteroid

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

Q: Would this be the inaugural research project of its type?

Since 2014, Genentech Inc. has been spearheading research into GA101/HDMP with the first trial involving 40 participants. The drug was approved for Phase 1 &#x26; 2 in that same year and currently there are 100 active studies of this medication taking place internationally across 948 cities within 46 nations.

Q: What precedent has been established for GA101/HDMP clinical studies?

Currently, 100 experiments related to GA101/HDMP are operational with 18 of them in their third phase. While the primary research hub is located in La Jolla, <a href="https://www.withpower.com/clinical-trials/california">California</a>, 4852 other sites host trials for this medication.

Q: Are there any vacancies remaining for this experiment?

At the present moment, this trial is no longer recruiting participants. It was initially posted on September 1st 2014 and last amended on September 2nd 2021. For anyone else in search of trials with an enrollment period still open, there are currently 666 studies for <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, lymphoid-related cancers and 100 concerning GA101/HDMP accepting volunteers.

Q: What is the magnitude of volunteers engaging in this clinical exploration?

At this time, no new participants are being recruited for the trial. This research initiative was published on September 1st 2014 and last amended on September 2nd 2021. However, there are currently 666 studies searching for patients with <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> or lymphoid conditions and 100 open trials involving GA101/HDMP that could use additional volunteers.

Phase 1 & 2

Waitlist Available

Led By Kipps Thomas, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hepatic parameters: Total Bilirubin < 3 x ULN, ALT and AST < 3 x ULN

Diagnosis of CLL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

GA101 & HDMP Trial Summary

This trial will test if a new cancer drug is effective and has fewer side effects than existing treatments.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the monoclonal antibody therapy, infusion-related reactions from the drug administration, as well as impacts on organ functions due to both medications involved.

GA101 & HDMP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver function tests are within normal limits.

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I have been diagnosed with chronic lymphocytic leukemia (CLL).

Select...

I can do most of my daily activities without help.

Select...

My kidneys are functioning well enough (creatinine clearance over 30 mL/min).

GA101 & HDMP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events that constitute the Dose Limiting Toxicity

Response assessment based on IWCLL

Secondary outcome measures

Overall Survival and Minimal residual disease (MRD)

Progression Free Survival

GA101 & HDMP Trial Design

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,595 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,539 Previous Clinical Trials

567,649 Total Patients Enrolled

Kipps Thomas, MDPrincipal InvestigatorUniversity of California, San Diego

Media Library

Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02229422 — Phase 1 & 2

Chronic Lymphocytic Leukemia Research Study Groups: GA101/HDMP

Chronic Lymphocytic Leukemia Clinical Trial 2023: Methylprednisolone Highlights & Side Effects. Trial Name: NCT02229422 — Phase 1 & 2

Methylprednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02229422 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this be the inaugural research project of its type?

"Since 2014, Genentech Inc. has been spearheading research into GA101/HDMP with the first trial involving 40 participants. The drug was approved for Phase 1 & 2 in that same year and currently there are 100 active studies of this medication taking place internationally across 948 cities within 46 nations."

Answered by AI

What precedent has been established for GA101/HDMP clinical studies?

"Currently, 100 experiments related to GA101/HDMP are operational with 18 of them in their third phase. While the primary research hub is located in La Jolla, California, 4852 other sites host trials for this medication."

Answered by AI

Are there any vacancies remaining for this experiment?

"At the present moment, this trial is no longer recruiting participants. It was initially posted on September 1st 2014 and last amended on September 2nd 2021. For anyone else in search of trials with an enrollment period still open, there are currently 666 studies for leukemia, lymphoid-related cancers and 100 concerning GA101/HDMP accepting volunteers."

Answered by AI

What is the magnitude of volunteers engaging in this clinical exploration?

"At this time, no new participants are being recruited for the trial. This research initiative was published on September 1st 2014 and last amended on September 2nd 2021. However, there are currently 666 studies searching for patients with leukemia or lymphoid conditions and 100 open trials involving GA101/HDMP that could use additional volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Obinutuzumab(GA101) in Combination With High-Dose Methylprednisolone(HDMP) in Chronic Lymphocytic Leukemia(CLL) Patients (GA101 & HDMP)

Thomas Kipps 2014. "A Study of Obinutuzumab(GA101) in Combination With High-Dose Methylprednisolone(HDMP) in Chronic Lymphocytic Leukemia(CLL) Patients (GA101 & HDMP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02229422.

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