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Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Venetoclax
Obinutuzumab
Acalabrutinib
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of CLL or SLL according to WHO criteria
  • Participants must require therapy according to iwCLL 2018 guidelines
  • Participants must have ≥ 2 points (high or intermediate risk disease) according to the CLL

BALL Risk Model:

  • Beta-2 microglobulin If ≥ 5 mg/L, assign 1 point
  • Lactate dehydrogenase If >institutional upper limit of normal, assign 1 point
  • Hemoglobin If <11 g/dL (female) or <12 g/dL (male), assign 1 point
  • Time from start of last therapy If <24 months, assign 1 point, If 4 points, patient is high risk, If 2-3 points, patient is intermediate risk, If 0-1 points, patient is low risk

    • Participants must have received prior systemic therapy for CLL
    • Age over 18 years
    • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
    • Participants must have adequate organ function as defined below:
  • total bilirubin ≤2 × institutional upper limit of normal unless considered secondary to Gilbert's syndrome, in which case ≤3 x ULN
  • AST(SGOT)/ALT(SGPT) ≤2 × institutional upper limit of normal
  • creatinine within normal institutional limits OR
  • creatinine clearance ≥30 mL/min according to the Cockcroft-Gault Equation for participants with creatinine levels above institutional normal.

    • Participants must have adequate marrow function as defined below (unless clearly due to disease under study per investigator discretion)
  • absolute neutrophil count ≥1,000/mcL
  • platelets ≥75,000/mcL OR
  • > 20,000/mcL if thrombocytopenia is clearly due to disease under study (per investigator discretion).

    • For females of childbearing potential, a negative serum pregnancy test within 7 days of study treatment
    • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [<1% per year] when used consistently and correctly) and to continue its use for 90 days after the last dose of acalabrutinib or venetoclax AND for 18 months after the last dose of obinutuzumab (whichever date is later)
    • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
    • Willingness to not donate sperm or oocytes during the entire study treatment period and after treatment discontinuation
    • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Prior therapy with a BTK inhibitor (e.g. acalabrutinib) or BCL2 inhibitor (e.g. venetoclax), with the following exception:
  • Patients with undetectable MRD by flow cytometry at 10 (peripheral blood or bone marrow) or CR from prior treatment with BCL2 inhibitor (with or without BTK inhibitor) are eligible. Note: Patients who received prior BTK inhibitor therapy alone are not eligible.
  • Known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients
  • Participants who are receiving any other investigational agents unless authorized by the overall study principal investigator
  • Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter's transformation)
  • Active malignancy or systemic therapy for another malignancy within 3 years; local/regional therapy with curative intent such as surgical resection or localized radiation within 3 years of treatment is permitted; active prostate cancer that is considered low-risk and appropriate for continued active surveillance strategy is permitted.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to Cycle 1, Day 1
  • Known bleeding diathesis
  • Pregnant women are excluded from this study because the study agents have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued if the mother is treated with study therapy.
  • Prior major surgical procedure within 4 weeks of study, or anticipation of need for a major surgical procedure during the course of the study
  • Known CNS hemorrhage or stroke within 6 months of the study
  • History of progressive multifocal leukoencephalopathy (PML)
  • History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection

    • Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to take appropriate anti-viral prophylaxis as indicated and undergo monthly DNA testing.
    • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
  • Congestive heart failure, New York Heart Association classification III/IV
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment
  • Known condition or other clinical situation that would affect oral absorption
  • Psychiatric illness/social situations that would interfere with study compliance
  • Receipt of therapy with strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9 and CYP2C19, within 7 days prior to the first dose of study drug administration
  • Consumption of grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug administration.
  • Requires dual antiplatelet therapy or anticoagulation with warfarin

Sites / Locations

  • Massachusetts General Hospital Cancer CenterRecruiting
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venetoclax-Obinutuzumab +/- Acalabrutinib

Arm Description

A treatment cycle is defined as 28 consecutive days. Participants with undetectable MRD (uMRD) at 1 year will complete an additional 1 year of VO then stop therapy. Participants with high detectable MRD at 1 year will complete an additional 1 year of VO plus acalabrutinib then stop therapy. Participants with low detectable MRD at 1 year will complete an additional 1 year of VO alone. If this eradicates MRD, they will stop therapy. If there is still residual MRD, they will complete an additional 1 year of IVO then stop therapy. If progression occurs on VO, I will be added and IV will be administered indefinitely. After 2 years, V may be stopped and I continued as monotherapy at investigator discretion. Infused Study Drug: Obinutuzumab on Days 1, 2, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 1-6 Oral Study Drugs: Venetoclax daily starting on Cycle 1 Day 22 Oral Drug: acalabrutinib daily for Days 1-28 (if applicable)

Outcomes

Primary Outcome Measures

Percentage of participants alive at 1 year
Percent of participants with high and intermediate risk relapsed/refractory CLL who are alive at 1 year. The percent of patients who are alive at one-year (rOS) will be measured by monitoring you in clinic. An rOS of at least 90% will be considered promising whereas the rOS of 75% or less will be considered non-promising.

Secondary Outcome Measures

Overall Response Rate
The response will be classified per the 2018 iwCLL guidelines. The overall frequency of overall response will be tabulated and summarized descriptively
Complete response rate
The response will be classified per the 2018 iwCLL guidelines. The overall frequency of complete response will be tabulated and summarized descriptively
Frequency of undetectable minimum residual disease (uMRD) after 12 Months
Frequency of undetectable MRD response will be tabulated and summarized descriptively. The frequency of detectable MRD including the frequency of MRD "low positive" and MRD "high positive" will also be tabulated and summarized descriptively
Undetectable MRD rate with addition of acalabrutinib to venetoclax-obinutuzumab among patients who fail to eradicate MRD with venetoclax-obinutuzumab
Among participants who fail to eradicate MRD with venetoclax-obinutuzumab (includes participants with detectable MRD at 12 months as well as those with progression prior to completion of 12 months of venetoclax-obinutuzumab), the frequency of uMRD following addition of acalabrutinib to VO will be tabulated and summarized descriptively.
Progression-free Survival
Progression-free survival (PFS) is defined as the interval between the first treatment day to the first sign of disease progression or death from any cause. Subjects without progression are censored at date of last disease evaluation
Overall Survival
Overall survival (OS) is defined as the interval between the first treatment day to death from any cause. Subjects without death are censored at date of last visit.
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE ver. 5.0.
Participants have their toxicities graded and reported at every visit according to the CTCAE ver. 5.0 grading scale. The nature, frequency, severity, and timing of adverse events will be tabulated and summarized descriptively.

Full Information

First Posted
September 17, 2020
Last Updated
July 5, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04560322
Brief Title
Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL
Official Title
A Phase 2 Study of MRD Adapted Therapy With Venetoclax-obinutuzumab in Patients With High or Intermediate BALL Risk Relapsed or Refractory CLL, With Addition of Acalabrutinib in Patients Who Fail to Achieve MRD Eradication
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study is studying a combination of drugs as a possible treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The names of the study drugs involved in this study are: obinutuzumab venetoclax acalabrutinib
Detailed Description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied. The U.S. Food and Drug Administration (FDA) has approved [1] venetoclax- obinutuzumab and [2] acalabrutinib individually as treatment options for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). However, the combination of all 3 drugs has not yet been approved by the FDA. Venetoclax is a targeted therapy drug that works by blocking a protein called Bcl-2 in cancer cells. Bcl-2 helps cancer cells survive and resist the effects of cancer treatments. By blocking Bcl-2, venetoclax may kill cancer cells and/or make them more open to the effects of other cancer treatments. Obinutuzumab is a drug that targets a protein called CD20, which is found on the surface of B cells, the white blood cells that are affected by CLL. When obinutuzumab attaches to CD20, it directly both destroys the B cells and makes them more "visible" to the immune system. The immune system then attacks and destroys the cancerous B cells. Acalabrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a protein inside of the cell that may be over-expressed in malignant B cells. It is involved in the signaling pathway from the B-cell receptor. BTK inhibition caused by taking acalabrutinib results in decreased malignant B-cell growth and survival. On this study, participants will receive obinutuzumab and venetoclax. We will monitor for minimal residual disease (MRD) using a test called "Adaptive ClonoSEQ" after treatment with obinutuzumab and venetoclax. MRD is a molecular test, which can detect whether there is any evidence of CLL/SLL in the blood or bone marrow. For participants with detectable MRD despite treatment with obinutuzumab and venetoclax, acalabrutinib will be added with the goal of achieving undetectable MRD. Additionally, for participants who have progressive CLL/SLL despite venetoclax and obinutuzumab, acalabrutinib will be added. The research study procedures include screening for eligibility, study treatment, end of treatment visit, follow-up visits and an off-study visit. Participants will receive study treatment for 2 or 3 years. Participants will be followed for 2 years after completion of the study. It is expected that 40 people will take part in this research study Genentech is supporting this research study by providing venetoclax and obinutuzumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Venetoclax-Obinutuzumab +/- Acalabrutinib
Arm Type
Experimental
Arm Description
A treatment cycle is defined as 28 consecutive days. Participants with undetectable MRD (uMRD) at 1 year will complete an additional 1 year of VO then stop therapy. Participants with high detectable MRD at 1 year will complete an additional 1 year of VO plus acalabrutinib then stop therapy. Participants with low detectable MRD at 1 year will complete an additional 1 year of VO alone. If this eradicates MRD, they will stop therapy. If there is still residual MRD, they will complete an additional 1 year of IVO then stop therapy. If progression occurs on VO, I will be added and IV will be administered indefinitely. After 2 years, V may be stopped and I continued as monotherapy at investigator discretion. Infused Study Drug: Obinutuzumab on Days 1, 2, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 1-6 Oral Study Drugs: Venetoclax daily starting on Cycle 1 Day 22 Oral Drug: acalabrutinib daily for Days 1-28 (if applicable)
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
Venclexta
Intervention Description
Tablet, taken by mouth
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
Gazyva
Intervention Description
Intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Acalabrutinib
Other Intervention Name(s)
Calquence
Intervention Description
Capsule, taken by mouth
Primary Outcome Measure Information:
Title
Percentage of participants alive at 1 year
Description
Percent of participants with high and intermediate risk relapsed/refractory CLL who are alive at 1 year. The percent of patients who are alive at one-year (rOS) will be measured by monitoring you in clinic. An rOS of at least 90% will be considered promising whereas the rOS of 75% or less will be considered non-promising.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
The response will be classified per the 2018 iwCLL guidelines. The overall frequency of overall response will be tabulated and summarized descriptively
Time Frame
1 year
Title
Complete response rate
Description
The response will be classified per the 2018 iwCLL guidelines. The overall frequency of complete response will be tabulated and summarized descriptively
Time Frame
1 year
Title
Frequency of undetectable minimum residual disease (uMRD) after 12 Months
Description
Frequency of undetectable MRD response will be tabulated and summarized descriptively. The frequency of detectable MRD including the frequency of MRD "low positive" and MRD "high positive" will also be tabulated and summarized descriptively
Time Frame
1 year
Title
Undetectable MRD rate with addition of acalabrutinib to venetoclax-obinutuzumab among patients who fail to eradicate MRD with venetoclax-obinutuzumab
Description
Among participants who fail to eradicate MRD with venetoclax-obinutuzumab (includes participants with detectable MRD at 12 months as well as those with progression prior to completion of 12 months of venetoclax-obinutuzumab), the frequency of uMRD following addition of acalabrutinib to VO will be tabulated and summarized descriptively.
Time Frame
12 months
Title
Progression-free Survival
Description
Progression-free survival (PFS) is defined as the interval between the first treatment day to the first sign of disease progression or death from any cause. Subjects without progression are censored at date of last disease evaluation
Time Frame
6 years
Title
Overall Survival
Description
Overall survival (OS) is defined as the interval between the first treatment day to death from any cause. Subjects without death are censored at date of last visit.
Time Frame
6 years
Title
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE ver. 5.0.
Description
Participants have their toxicities graded and reported at every visit according to the CTCAE ver. 5.0 grading scale. The nature, frequency, severity, and timing of adverse events will be tabulated and summarized descriptively.
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of CLL or SLL according to WHO criteria Participants must require therapy according to iwCLL 2018 guidelines Participants must have ≥ 2 points (high or intermediate risk disease) according to the CLL BALL Risk Model: Beta-2 microglobulin If ≥ 5 mg/L, assign 1 point Lactate dehydrogenase If >institutional upper limit of normal, assign 1 point Hemoglobin If <11 g/dL (female) or <12 g/dL (male), assign 1 point Time from start of last therapy If <24 months, assign 1 point, If 4 points, patient is high risk, If 2-3 points, patient is intermediate risk, If 0-1 points, patient is low risk Participants must have received prior systemic therapy for CLL Age over 18 years ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) Participants must have adequate organ function as defined below: total bilirubin ≤2 × institutional upper limit of normal unless considered secondary to Gilbert's syndrome, in which case ≤3 x ULN AST(SGOT)/ALT(SGPT) ≤2 × institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance ≥30 mL/min according to the Cockcroft-Gault Equation for participants with creatinine levels above institutional normal. Participants must have adequate marrow function as defined below (unless clearly due to disease under study per investigator discretion) absolute neutrophil count ≥1,000/mcL platelets ≥75,000/mcL OR > 20,000/mcL if thrombocytopenia is clearly due to disease under study (per investigator discretion). For females of childbearing potential, a negative serum pregnancy test within 7 days of study treatment For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [<1% per year] when used consistently and correctly) and to continue its use for 90 days after the last dose of acalabrutinib or venetoclax AND for 18 months after the last dose of obinutuzumab (whichever date is later) The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Willingness to not donate sperm or oocytes during the entire study treatment period and after treatment discontinuation Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Prior therapy with a BTK inhibitor (e.g. acalabrutinib) or BCL2 inhibitor (e.g. venetoclax), with the following exception: Patients with undetectable MRD by flow cytometry at 10 (peripheral blood or bone marrow) or CR from prior treatment with BCL2 inhibitor (with or without BTK inhibitor) are eligible. Note: Patients who received prior BTK inhibitor therapy alone are not eligible. Known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients Participants who are receiving any other investigational agents unless authorized by the overall study principal investigator Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter's transformation) Active malignancy or systemic therapy for another malignancy within 3 years; local/regional therapy with curative intent such as surgical resection or localized radiation within 3 years of treatment is permitted; active prostate cancer that is considered low-risk and appropriate for continued active surveillance strategy is permitted. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to Cycle 1, Day 1 Known bleeding diathesis Pregnant women are excluded from this study because the study agents have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued if the mother is treated with study therapy. Prior major surgical procedure within 4 weeks of study, or anticipation of need for a major surgical procedure during the course of the study Known CNS hemorrhage or stroke within 6 months of the study History of progressive multifocal leukoencephalopathy (PML) History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to take appropriate anti-viral prophylaxis as indicated and undergo monthly DNA testing. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA Congestive heart failure, New York Heart Association classification III/IV Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment Known condition or other clinical situation that would affect oral absorption Psychiatric illness/social situations that would interfere with study compliance Receipt of therapy with strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9 and CYP2C19, within 7 days prior to the first dose of study drug administration Consumption of grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug administration. Requires dual antiplatelet therapy or anticoagulation with warfarin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob D Soumerai, MD
Phone
617-724-4000
Email
jsoumerai@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob D Soumerai, MD
Email
jsoumerai@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob D Soumerai, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob D Soumerai, MD
Phone
617-724-4000
Email
jsoumerai@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jacob D Soumerai, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Arnason
Phone
617-667-9235
Email
jarnason@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jon Arnason, MD
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew S Davids, MD
Phone
617-632-6331
Email
matthew_davids@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Matthew S Davids, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation
Citations:
PubMed Identifier
31109827
Citation
Soumerai JD, Ni A, Darif M, Londhe A, Xing G, Mun Y, Kay NE, Shanafelt TD, Rabe KG, Byrd JC, Chanan-Khan AA, Furman RR, Hillmen P, Jones J, Seymour JF, Sharman JP, Ferrante L, Mobasher M, Stark T, Reddy V, Dreiling LK, Bhargava P, Howes A, James DF, Zelenetz AD. Prognostic risk score for patients with relapsed or refractory chronic lymphocytic leukaemia treated with targeted therapies or chemoimmunotherapy: a retrospective, pooled cohort study with external validations. Lancet Haematol. 2019 Jul;6(7):e366-e374. doi: 10.1016/S2352-3026(19)30085-7. Epub 2019 May 17. Erratum In: Lancet Haematol. 2019 Jul;6(7):e348.
Results Reference
background
Links:
URL
https://reference.medscape.com/calculator/485/cll-ball-score-for-relapsed-refractory-cll
Description
CLL BALL Score Calculator

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Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL

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