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Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma

Primary Purpose

Lymphoma, T-Cell

Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Azacitidine
Romidepsin
Gemcitabine
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, T-Cell focused on measuring CC-486, Azacitidine, Angioimmunoblastic, T Cell Lymphoma, Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  2. Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.
  3. Patient is willing and able to adhere to the study visit schedule and other protocol requirements
  4. Patient had local diagnosed peripheral T cell lymphoma (PTCL) with T-follicular helper (TFH) phenotype according to the criteria of the latest WHO classification based on a surgical lymph node biopsy or needle core biopsy including any one of

    • Angioimmunoblastic T cell lymphoma (AITL)
    • Follicular T cell lymphoma
    • Nodal peripheral T-cell lymphoma with TFH phenotype There should be a documented expression of minimum two TFH markers among this panel of markers: CD10, CXCL13, PD1, ICOS and BCL6 by the tumoral cells by immunohistochemistry. Biopsy at relapse or progression is not mandatory, but highly encouraged on a surgical or needle core biopsy, and diagnostic tissue should be available for central pathology review and for ancillary molecular studies.

    Local pathology report should be reviewed by the sponsor's medical monitor prior to enrollment.

  5. ECOG performance status 0 to 3
  6. Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below.)
  7. Meet the following lab criteria:

    • ANC ≥ 1,5 x 109/L (≥ 1 x 109/L if BM involvement by lymphoma)
    • Platelet ≥ 75 x 109/L (≥ 50 x 109/L if BM involvement by lymphoma)
    • Hemoglobin ≥ 8 g/dL.
  8. Anticipated life expectancy at least 3 months
  9. At least one measurable lesion on CT that is greater than 1.5 cm in the longest diameter for nodal lesions and greater than 1.0 cm in the longest diameter for extranodal lesions. The lesion must be measurable in two perpendicular dimensions. Patients with only cutaneous disease will be excluded.
  10. Female patient of childbearing potential (FCBP) may participate, providing she meets the following conditions:

    Have two negative pregnancy tests as verified by the investigator prior to starting study treatment: serum pregnancy test at Screening and negative serum or urine pregnancy test (investigator's discretion) within 72 hours prior to starting treatment with study treatment (Cycle 1 Day 1). She must agree to ongoing pregnancy testing during the study (before beginning each subsequent cycle of treatment), and 28 days after the last study drug administration. This applies even if the patient practices complete abstinence from heterosexual contact.

    Agrees to practice true abstinence (which must be reviewed monthly and source documented) or agrees to the use of highly effective methods of contraception from 28 days prior to starting study treatment, and must agree to continue using such precautions during study treatment (including dose interruptions) and for up to 6 months after the last study drug administration. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptomthermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. Cessation of contraception after this point should be discussed with a responsible physician.

    Agrees to abstain from breastfeeding during study participation and for at least 6 months after the last study drug administration.

    A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).

  11. Male patient must either practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agrees to avoid fathering a child, to use highly effective methods of contraception, male condom plus spermicide during sexual contact with a pregnant female or a female of childbearing potential (even if he has undergone a successful vasectomy), from starting dose of IP (cycle 1 Day 1), including dose interruptions through 6 months after receipt of the last study drug administration.

    Furthermore, male patient must agree to not give semen or sperm during study drug therapy and for a period of 1 year after end of study drug therapy.

  12. For EU countries, patient covered by a social security system

Exclusion Criteria:

  1. Clinical evidence of central nervous system(CNS) involvement by lymphoma. Patients with suspicion of CNS involvement must undergo neurologic evaluation and CT/MRI of head and lumbar puncture to exclude CNS disease.
  2. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)
  3. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
  4. Known Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection defined as:

    • HBs Ag positive
    • HBs Ag negative, anti-HBs antibody positive and/or anti-HBc antibody positive with detectable viral DNA
  5. Impaired renal function (calculated MDRD or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (Serum total bilirubin level > 2.0 mg/dl [34 μmol/L] (except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma), Serum transaminases (AST or ALT) > 3 upper normal limits) unless they are related to the lymphoma.
  6. Active malignancy other than the one treated in this research. Prior history of malignancies, other than low risk MDS or CMML (with less than 5% blasts in bone marrow), unless the patient has been free of the disease for ≥ 3 years. However, patients with the following history/concurrent conditions are allowed:

    1. Basal or squamous cell carcinoma of the skin
    2. Carcinoma in situ of the cervix
    3. Carcinoma in situ of the breast
    4. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis [TNM] clinical staging system
  7. Treatment with any investigational drug within 5 half-lives before planned first cycle of study treatment and during the study. Ongoing medically significant adverse events from previous treatment, regardless of the time period.
  8. Prior exposure to azacitidine and/ or any other demethylating agent (eg, decitabine)
  9. Prior exposure to planned study treatment investigator's choice therapy (eg, prior exposure to gemcitabine is an exclusion if gemcitabine is the investigator's choice therapy prior to randomization)
  10. Concurrent use of corticosteroids unless the patient is on a stable or decreasing dose for ≥ 1 week prior to informed consent form signature
  11. Knowing or suspected hypersensitivity to active substance or to any of the excipients.
  12. Pregnant, planning to become pregnant, or lactating woman
  13. Candidate for hematopoietic stem cell transplantation
  14. History of active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the oral azacitidine and/or predispose the patient to an increased risk of gastrointestinal toxicity per investigator's decision. Any condition causing inability to swallow tablets.
  15. Significant active cardiac disease within the previous 6 months, including:

    • New York Heart Association (NYHA) class IV congestive heart failure
    • Unstable angina or angina requiring surgical or medical intervention; and/or
    • Myocardial infarction
  16. Person deprived of his/her liberty by a judicial or administrative decision
  17. Adult person under legal protection

Sites / Locations

  • Local Institution - 41922
  • Local Institution - 41722
  • Local Institution - 41422
  • Local Institution - 40722
  • National Cancer Center Hospital
  • Kyushu University Hospital
  • Saitama Medical University International Medical Center
  • Tokai University Hospital
  • Local Institution - 41522
  • National Cancer Center Hospital East
  • Local Institution - 40222
  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research
  • Local Institution - 41622
  • National Hospital Organization - Nagoya Medical Center
  • Okayama University Hospital
  • Kindai University Hospital
  • Hokkaido University Hospital
  • Local Institution - 41822
  • Tohoku University Hospital
  • Local Institution - 41322
  • University of Tsukuba Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Administration of Oral Azacitidine (CC-486)

Investigator's choice therapy - Romidepsin

Investigator's choice therapy - Gemcitabine

Arm Description

Oral azacytidine 300 mg during 14 first days of 28-days cycle for European (EU) patients, Oral azacytidine 200 mg during 14 first days of 28-days cycle for Asian patients (Treatment until progression, patient decision or toxicity)

Romidepsin 14mg/m2 on days 1, 8 and 15 of a 28-days cycle (Treatment until progression, patient decision or toxicity)

Gemcitabine 1000mg/m2 on days 1, 8 and 15 of a 28-days cycle (during 6 cycles)

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
Is the time from randomization into the study to the first observation of documented disease progression or death due to any cause.
Progression Free Survival (PFS)
Is the time from randomization into the study to the first observation of documented disease progression or death due to any cause.

Secondary Outcome Measures

Overall Survival (OS)
Is the time from the date of randomization to the date of death from any cause. Alive patients will be censored at their last contact.
Progression Free Survival (PFS) by Independent Review Committee (IRC)
Is the time from randomization into the study to the first observation of documented disease progression or death due to any cause.
Overall Response Rate (ORR)
Is the percentage of Complete Response (CR) + Partial Response (PR) among all patients.
Complete Response Rate (CRR)
Is the percentage of Complete Response (CR) among all patients.
Duration of Response
Is the time from attainment of CR or PR to the date of first documented disease progression, relapse (local assessment) or death from any cause.
Time to Response
Is the time from randomization to the date of attainment of CR or PR until end of treatment.
PFS2 using local assessment of progressive disease
Is the time from randomization to objective tumor progression on next-line treatment or death from any cause.
EORTC QLQ-C30
The QLQC30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/QOL scale, and six single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
Adverse Events (AEs)
Number of subjects with Adverse Event

Full Information

First Posted
October 9, 2018
Last Updated
November 11, 2022
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT03703375
Brief Title
Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
Official Title
Randomized Phase 3 Study Evaluation the Efficacy and Safety of Oral Azacitidine(CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a multicentric, open-label, randomized phase 3 trial. The study will be conducted in select countries in Europe and South Korea sponsored by LYSARC and in Japan sponsored by Celgene. There will be a combined enrollment target of 86 randomized patients, with approximately 14 randomized patients from Japan. The enrollment to the randomized study will start at European sites in parallel to a safety run-in part in Japan. A safety run-in will be conducted to confirm the tolerability of oral azacitidine at doses of 100 mg and 200 mg QD in Asian patients. Once oral azacitidine at 200 mg QD is confirmed as tolerable, Asian patients from Japan and South Korea will start to be randomized into the main study. Additional patients (non-randomized) are anticipated to enroll to the safety run-in.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, T-Cell
Keywords
CC-486, Azacitidine, Angioimmunoblastic, T Cell Lymphoma, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Administration of Oral Azacitidine (CC-486)
Arm Type
Experimental
Arm Description
Oral azacytidine 300 mg during 14 first days of 28-days cycle for European (EU) patients, Oral azacytidine 200 mg during 14 first days of 28-days cycle for Asian patients (Treatment until progression, patient decision or toxicity)
Arm Title
Investigator's choice therapy - Romidepsin
Arm Type
Active Comparator
Arm Description
Romidepsin 14mg/m2 on days 1, 8 and 15 of a 28-days cycle (Treatment until progression, patient decision or toxicity)
Arm Title
Investigator's choice therapy - Gemcitabine
Arm Type
Active Comparator
Arm Description
Gemcitabine 1000mg/m2 on days 1, 8 and 15 of a 28-days cycle (during 6 cycles)
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
CC-486
Intervention Description
Azacitidine
Intervention Type
Drug
Intervention Name(s)
Romidepsin
Intervention Description
Romidepsin
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Is the time from randomization into the study to the first observation of documented disease progression or death due to any cause.
Time Frame
18 months after first randomization
Title
Progression Free Survival (PFS)
Description
Is the time from randomization into the study to the first observation of documented disease progression or death due to any cause.
Time Frame
35 months after first randomization
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Is the time from the date of randomization to the date of death from any cause. Alive patients will be censored at their last contact.
Time Frame
40 months after first randomization
Title
Progression Free Survival (PFS) by Independent Review Committee (IRC)
Description
Is the time from randomization into the study to the first observation of documented disease progression or death due to any cause.
Time Frame
40 months after first randomization
Title
Overall Response Rate (ORR)
Description
Is the percentage of Complete Response (CR) + Partial Response (PR) among all patients.
Time Frame
40 months after first randomization
Title
Complete Response Rate (CRR)
Description
Is the percentage of Complete Response (CR) among all patients.
Time Frame
40 months after first randomization
Title
Duration of Response
Description
Is the time from attainment of CR or PR to the date of first documented disease progression, relapse (local assessment) or death from any cause.
Time Frame
40 months after first randomization
Title
Time to Response
Description
Is the time from randomization to the date of attainment of CR or PR until end of treatment.
Time Frame
40 months after first randomization
Title
PFS2 using local assessment of progressive disease
Description
Is the time from randomization to objective tumor progression on next-line treatment or death from any cause.
Time Frame
40 months after first randomization
Title
EORTC QLQ-C30
Description
The QLQC30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/QOL scale, and six single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
Time Frame
2 years after last randomization
Title
Adverse Events (AEs)
Description
Number of subjects with Adverse Event
Time Frame
2 years after last randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF). Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted. Patient is willing and able to adhere to the study visit schedule and other protocol requirements Patient had local diagnosed peripheral T cell lymphoma (PTCL) with T-follicular helper (TFH) phenotype according to the criteria of the latest WHO classification based on a surgical lymph node biopsy or needle core biopsy including any one of Angioimmunoblastic T cell lymphoma (AITL) Follicular T cell lymphoma Nodal peripheral T-cell lymphoma with TFH phenotype There should be a documented expression of minimum two TFH markers among this panel of markers: CD10, CXCL13, PD1, ICOS and BCL6 by the tumoral cells by immunohistochemistry. Biopsy at relapse or progression is not mandatory, but highly encouraged on a surgical or needle core biopsy, and diagnostic tissue should be available for central pathology review and for ancillary molecular studies. Local pathology report should be reviewed by the sponsor's medical monitor prior to enrollment. ECOG performance status 0 to 3 Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below.) Meet the following lab criteria: ANC ≥ 1,5 x 109/L (≥ 1 x 109/L if BM involvement by lymphoma) Platelet ≥ 75 x 109/L (≥ 50 x 109/L if BM involvement by lymphoma) Hemoglobin ≥ 8 g/dL. Anticipated life expectancy at least 3 months At least one measurable lesion on CT that is greater than 1.5 cm in the longest diameter for nodal lesions and greater than 1.0 cm in the longest diameter for extranodal lesions. The lesion must be measurable in two perpendicular dimensions. Patients with only cutaneous disease will be excluded. Female patient of childbearing potential (FCBP) may participate, providing she meets the following conditions: Have two negative pregnancy tests as verified by the investigator prior to starting study treatment: serum pregnancy test at Screening and negative serum or urine pregnancy test (investigator's discretion) within 72 hours prior to starting treatment with study treatment (Cycle 1 Day 1). She must agree to ongoing pregnancy testing during the study (before beginning each subsequent cycle of treatment), and 28 days after the last study drug administration. This applies even if the patient practices complete abstinence from heterosexual contact. Agrees to practice true abstinence (which must be reviewed monthly and source documented) or agrees to the use of highly effective methods of contraception from 28 days prior to starting study treatment, and must agree to continue using such precautions during study treatment (including dose interruptions) and for up to 6 months after the last study drug administration. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptomthermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. Cessation of contraception after this point should be discussed with a responsible physician. Agrees to abstain from breastfeeding during study participation and for at least 6 months after the last study drug administration. A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months). Male patient must either practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agrees to avoid fathering a child, to use highly effective methods of contraception, male condom plus spermicide during sexual contact with a pregnant female or a female of childbearing potential (even if he has undergone a successful vasectomy), from starting dose of IP (cycle 1 Day 1), including dose interruptions through 6 months after receipt of the last study drug administration. Furthermore, male patient must agree to not give semen or sperm during study drug therapy and for a period of 1 year after end of study drug therapy. For EU countries, patient covered by a social security system Exclusion Criteria: Clinical evidence of central nervous system(CNS) involvement by lymphoma. Patients with suspicion of CNS involvement must undergo neurologic evaluation and CT/MRI of head and lumbar puncture to exclude CNS disease. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision) Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment) Known Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection defined as: HBs Ag positive HBs Ag negative, anti-HBs antibody positive and/or anti-HBc antibody positive with detectable viral DNA Impaired renal function (calculated MDRD or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (Serum total bilirubin level > 2.0 mg/dl [34 μmol/L] (except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma), Serum transaminases (AST or ALT) > 3 upper normal limits) unless they are related to the lymphoma. Active malignancy other than the one treated in this research. Prior history of malignancies, other than low risk MDS or CMML (with less than 5% blasts in bone marrow), unless the patient has been free of the disease for ≥ 3 years. However, patients with the following history/concurrent conditions are allowed: Basal or squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis [TNM] clinical staging system Treatment with any investigational drug within 5 half-lives before planned first cycle of study treatment and during the study. Ongoing medically significant adverse events from previous treatment, regardless of the time period. Prior exposure to azacitidine and/ or any other demethylating agent (eg, decitabine) Prior exposure to planned study treatment investigator's choice therapy (eg, prior exposure to gemcitabine is an exclusion if gemcitabine is the investigator's choice therapy prior to randomization) Concurrent use of corticosteroids unless the patient is on a stable or decreasing dose for ≥ 1 week prior to informed consent form signature Knowing or suspected hypersensitivity to active substance or to any of the excipients. Pregnant, planning to become pregnant, or lactating woman Candidate for hematopoietic stem cell transplantation History of active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the oral azacitidine and/or predispose the patient to an increased risk of gastrointestinal toxicity per investigator's decision. Any condition causing inability to swallow tablets. Significant active cardiac disease within the previous 6 months, including: New York Heart Association (NYHA) class IV congestive heart failure Unstable angina or angina requiring surgical or medical intervention; and/or Myocardial infarction Person deprived of his/her liberty by a judicial or administrative decision Adult person under legal protection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 41922
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Local Institution - 41722
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution - 41422
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Local Institution - 40722
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara City, Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Local Institution - 41522
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Local Institution - 40222
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Local Institution - 41622
City
Nagoya-shi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National Hospital Organization - Nagoya Medical Center
City
Nagoya-shi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka-Sayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo, Hokkaidô
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Local Institution - 41822
City
Sapporo, Hokkaidô
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Local Institution - 41322
City
Tsukuba
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba
ZIP/Postal Code
305-8576
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting

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Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma

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