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CLLPhase 1/2GA101 & HDMPNCT02229422

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

A Phase 1/2 study testing GA101/HDMP in people with CLL, run by University of California, San Diego at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

We hypothesize that GA101 - Obinutuzumab in combination with HDMP is well tolerated and will induce similar if not higher response rates than the ones observed in Rituximab plus HDMP studies (Castro et al., 2009, Castro et al., 2008). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CLL
What is being tested?
GA101/HDMP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Sep 2014to 25 Dec 2025
Phase
Phase 1/2
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

  • Diagnosis of CLL
  • Indication for treatment as defined by the IWCLL Guidelines (Hallek et al., 2008b).
  • Males and females 18 years of age and older.
  • Laboratory parameters as specified below:
  • Hematologic: Hemoglobin > 8 g/dL (may be post-transfusion); platelet count > 40 x103/mm3 (may be post-transfusion). Absolute neutrophil count > 1.0 109 cells/mm3 (Growth factor use is allowed).
  • Hepatic: Total Bilirubin < 3 x ULN, and ALT and AST < 3 x ULN
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  • Renal: Creatinine clearance > 30 mL/min (Calculated according to institutional standards or using Cockcroft-Gault formula. Subjects with requirement of hemodialysis will be excluded).
  • ECOG Performance Status < 2, unless the decline of the performance status is considered to be related to CLL symptoms.
  • Anticipated survival of at least 6 months.
  • Subjects can be enrolled and treated under this protocol regardless of their CLL treatment history or number of previous treatments. In addition, subjects with history of allogeneic stem cell transplant can be enrolled and treated unless they have active manifestations of graft vs. host disease (GVHD) or chronic illness or infections that will prevent them from completing the study.
  • Previously untreated subjects 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 ≥ 2), advance age (> 65 years), Cumulative Illness Rating Scale (CIRS score) ≥ 6 or cytopenias.
  • Effective contraception is required while receiving 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.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
  • Subjects must give written informed consent to participate in this trial.

Who cannot join

  • Pregnant or nursing women.
  • Treatment with chemotherapy, monoclonal antibodies or biological agents (e.g. Ibrutinib, lenalidomide) within 28 days prior to entering the study.
  • Treatment with chemotherapy, monoclonal antibodies, biological agents (e.g. Ibrutinib) or other than the investigational agents during the time of participation in this trial.
  • Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
  • Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
  • Participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol.
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  • 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.
  • Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with HIV, human T-cell leukemia virus 1 (HTLV-1) seropositive status.
  • Evidence of active acute or chronic Hepatitis B (HBV).
  • Evidence of active Hepatitis C (HCV): subjects with positive hepatitis C serology AND positive HCV RNA test.
  • Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study's endpoints.
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
  • Known hypersensitivity to any of the study drugs.
  • Major surgery (within 4 weeks prior to the start of Cycle 1), except for procedures that are performed for diagnostic purposes.
  • Men or women of childbearing potential who refuse to use an adequate measure of contraception (oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly) unless they have past medical history of surgical sterilization.
  • Vaccination with a live vaccine within 28 days of the initiation of treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

Other trials in United States

About this study

Official title: A Study of Obinutuzumab in Combination With High-Dose Methylprednisolone in Chronic Lymphocytic Leukemia Patients

We hypothesize that GA101 - Obinutuzumab in combination with HDMP is well tolerated and will induce similar if not higher response rates than the ones observed in Rituximab plus HDMP studies (Castro et al., 2009, Castro et al., 2008).

Read the detailed description

This is an open label phase Ib/II clinical trial to determine the safety and clinical activity of the GA101 - Obinutuzumab in combination with high-dose methylprednisone (HDMP). We will evaluate dose-limiting toxicities (DLTs) during the first month of therapy as part of the phase Ib of this study. In the phase II we will determine response rate in an intention to treat analysis. In this study we will include CLL patients that have never received treatment as well as patients that have failed previous treatments.

Conditions
CLL
Being tested
GA101/HDMP

What participants receive

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

  • GA101/HDMPDrug

    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.

Study groups in NCT02229422
Study groupRoleWhat they receive
GA101/HDMPExperimentalAll 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.
Receives: Drug: GA101/HDMP

What is being measured

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

  1. Adverse events that constitute the Dose Limiting Toxicity

    Measured: 2 months

  2. Response assessment based on IWCLL

    Measured: 2 months

Secondary outcomes (2)

  1. Progression Free Survival

    Measured: 2 years

  2. Overall Survival and Minimal residual disease (MRD)

    Measured: 2 years

Timeline

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

  1. First posted1 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion25 Dec 2025 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02229422
Sponsor's protocol ID
140396
Acronym
GA101 & HDMP
Status last verified
Aug 2023
First submitted
27 Aug 2014
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GA101/HDMP in people with CLL, run by University of California, San Diego 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 14 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. 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 combined 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.

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?

Results are not available in the source record.

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?

Adverse events that constitute the Dose Limiting Toxicity (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT02229422.

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 30 Aug 2023.

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