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Gazyva Infusion Reaction Investigation (GAIRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529227
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Healthy Future

Tracking Information
First Submitted Date March 29, 2018
First Posted Date May 18, 2018
Last Update Posted Date September 16, 2020
Actual Study Start Date March 31, 2018
Estimated Primary Completion Date August 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2018)
MRD status of CLL patients with comorbidities [ Time Frame: 3 months after the last dose of study treatment ]
Number of patients with positive and negative MRD status
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 7, 2018)
  • Response Rate (ORR) [ Time Frame: 3 months after last dose administration ]
    Frequency of the overall response in patients with CLL using the Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (N,%)
  • Progression free survival (PFS) by the Kaplan-Meier method [ Time Frame: 3 months after last dose administration ]
    Time to full remission in patients with CLL using Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (month) calculated by the Kaplan-Meier method
  • Duration of response (DOR) by the Kaplan-Meier method [ Time Frame: 3 months after last dose administration ]
    Time to partial remission in patients with CLL using Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (month) calculated by the Kaplan-Meier method
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gazyva Infusion Reaction Investigation
Official Title Prospective One-center Open Label Observational Efficacy & Safety Study of Chlorambucil & Obinutuzumab in Treatment of Unfit Patients With Untreated Chronic Lympho Leukemia With Comorbidities
Brief Summary The study evaluate safety and effectiveness of chlorambucil and obinutuzumab in routine clinical practice in patients with chronic lymphatic leukemia and with certain comorbidities (any cardiac pathology, diabetes mellitus (DM), kidney pathology or cytopenia), whom obinutuzumab & chlorambucil have been applied according to indications before enrollment in the study.
Detailed Description

MRD (Minimal residual disease) evaluation was chosen as a primary measure outcome as it is considered as prognostic marker for long-term progression freee survival (PFS) and as a potential therapeutic goal in chronic lymphocytic leukemia/ CLL .

Minimal residual disease (MRD-negative) is assessed in the clinic by 8-color flow cytometry giving the sensitivity level of MRD detection 10-5; MRD is measured in real clinical practice at this clinical center according to National recommendations in diagnostics and treatment of lymphoproliferative disorders.

To achieve study objectives medical patients' charts will be analyzed retrospectively. In the frame of this program 104 patients' charts treated in defined clinical site, are planned to be analyzed. This number of patients corresponds to the patient flow with this pathology at a defined clinical site for 1 years.

Data collection is considered to be retrospective as data will be transferred to e-CRF from patient medical charts. During this study no further specific extra procedures for data gathering is expected.

But since patients included in the study will be at the center of ongoing therapy, the study was called a prospective.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population It is expected to include 104 patient with primary diagnosed CLL elder 18 years with certain comorbidities as any cardiac pathology/ diabetes mellitus/ kidney pathology/ cytopenia (Hb <100 g/l, Platelets < 100 x 109/l) after Obinutuzumab + chlorambucil are applied as the 1st line treatment .
Condition Chronic Lymphocytic Leukemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 7, 2018)
104
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2025
Estimated Primary Completion Date August 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. CD20+/ (cluster of differentiation antigen 20 positive) B-CLL pts on the 1st line treatment therapy, whom have been already applied Obinutuzumab and chlorambucil
  2. Age ≥ 18 years.
  3. Eastern Cooperative Oncology Group Scale (ECOG) 0-2.
  4. Total Chronic Illness Resources Survey scale (CIRS) score >6 or creatinine clearance <70 ml/min or both for patients ≥ 18 years old or all CLL pts ≥ 75 years old
  5. Any cardiac pathology/ diabetes mellitus/ kidney pathology/ cytopenia (Hb <100 g/l, Platelets < 100 x 109/l)
  6. Life expectancy more than 6 months according to the physician's opinion.
  7. Signed informed consent that allow personal data and data that refer to patient confidentiality processing

Exclusion Criteria:

The refusal of the patient to participate in the observational study and the withdrawal of informed consent that allow processing of personal data and data that refer to patient confidentiality.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Eugeny A Nikitin, MD +7 916 572 06 eugene_nikitin@mail.ru
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT03529227
Other Study ID Numbers ML40194
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Healthy Future
Study Sponsor Healthy Future
Collaborators Not Provided
Investigators
Principal Investigator: Eugeny A Nikitin, MD "The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department"
PRS Account Healthy Future
Verification Date February 2020