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

UNKNOWNPHASE1/PHASE2

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

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

NCT02229422•University of California, San Diego

View on ClinicalTrials.gov

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).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of CLL
•2. Indication for treatment as defined by the IWCLL Guidelines (Hallek et al., 2008b).
•3. Males and females 18 years of age and older.
•4. 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
•* Renal: Creatinine clearance \> 30 mL/min (Calculated according to institutional standards or using Cockcroft-Gault formula. Subjects with requirement of hemodialysis will be excluded).
•5. ECOG Performance Status \< 2, unless the decline of the performance status is considered to be related to CLL symptoms.
•6. Anticipated survival of at least 6 months.
•7. 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.
+4 more criteria

Exclusion Criteria

•1. Pregnant or nursing women.
•2. Treatment with chemotherapy, monoclonal antibodies or biological agents (e.g. Ibrutinib, lenalidomide) within 28 days prior to entering the study.
•3. Treatment with chemotherapy, monoclonal antibodies, biological agents (e.g. Ibrutinib) or other than the investigational agents during the time of participation in this trial.
•4. Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
•5. Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
•6. Participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol.
•7. 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.
•8. Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with HIV, human T-cell leukemia virus 1 (HTLV-1) seropositive status.
•9. Evidence of active acute or chronic Hepatitis B (HBV).
•10. Evidence of active Hepatitis C (HCV): subjects with positive hepatitis C serology AND positive HCV RNA test.
+6 more criteria

Locations (1)

UCSD Moores Cancer Center

La Jolla, California, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

October 30, 2025

Completion Date

December 25, 2025

Last Updated

August 30, 2023

Enrollment

ACTUAL participants

Conditions

CLL

Interventions

GA101/HDMP

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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