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rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temzolomide

Primary Purpose

Glioma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rhIL-7-hyFc
Placebo
Temozolomide
Radiation therapy
Blood sample
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma

Eligibility Criteria

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

Inclusion Criteria:

  • World Health Organization (WHO) grade III, grade IV, and high risk grade II gliomas that require RT and TMZ treatment.
  • Phase 2 Expansion Cohort ONLY: Must be IDH1 wildtype, as defined by negative immunohistochemistry using an R132H-specific antibody and MGMT promoter unmethylated glioblastoma multiforme (WHO grade IV).
  • Post-operative treatment must have included radiation and TMZ. Prior Gliadel Wafers are allowed. Glucocorticoid therapy is allowed. Tumor treating fields (TTF) device is allowed.
  • Adequate organ and marrow function defined as follows:

    • Absolute neutrophil count ≥ 1,000/mcL
    • Platelets ≥ 75,000/mcL
    • Hemoglobin ≥ 8 g/dL
    • Total bilirubin ≤ 3.0 x institutional upper limit of normal
    • AST (SGOT)/ALT (SGPT) ≤ 3.0 × institutional upper limit of normal
    • Absolute lymphocyte count (ALC) ≥ 600/mcL (required for phase I and randomized phase II only)
  • Karnofsky Performance Status (KPS) ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
  • Able to provide written informed consent (or consent from a legally authorized representative).
  • Women of childbearing potential must have a negative serum pregnancy test prior to study entry (within 14 days). Patients must be willing to be on adequate contraception during treatment.

    • 18 years of age.

Exclusion Criteria:

  • Receiving any other investigational agents which may affect patient's lymphocyte counts.
  • Pregnant women are excluded from this study because rhIL-7-hyFc has not been evaluated regarding its potential for teratogenic or abortifacients effects. There is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug, breastfeeding should be discontinued if the mother is treated with rhIL-7-hyFc.
  • Has an active viral infection requiring systemic treatment at screening.
  • Has active autoimmune disease or syndrome (i.e. moderate or severe rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.,) that requires systemic treatment at the time of screening. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Subjects are permitted to enroll if they have vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Receipt of live attenuated vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), Zoster, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.

Sites / Locations

  • Mayo Clinic
  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase I: rhIL-7-hyFc

Randomized Phase II: Placebo

Randomized Phase II: rhIL-7-hyFc

Phase II Expansion Arm: rhIL-7-hyFc

Arm Description

Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels

-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.

Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.

Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.

Outcomes

Primary Outcome Measures

Phase I: Safety and tolerability of rhIL-7-hyFc as measured by the maximum tolerated dose (MTD) - Phase I only
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the non-tolerated dose. A total of at least 6 patients must be treated at a dose level for it to be considered the MTD.
Phase I: Safety and tolerability of rhIL-7-hyFc as measured by dose-limiting toxicities (DLTs)
-DLT will be defined as ≥ grade 3 non-dermatological and non-hematological AEs that occur within 30 days from the date when patients receive the 1st dose of rhIL-7-hyFc administration and are concluded to be possibly, likely or definitely related to the drug regimen that occurs during cycle 1, with severity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Randomized Phase II: Percent increase of absolute lymphocyte count
Phase II Expansion Cohort: Progression-free survival (PFS)
-Defined from date of surgery to date of progression or death due to disease or date of last clinical follow up.

Secondary Outcome Measures

Phase I and Randomized Phase II: Immunogenicity as measured by anti-drug antibodies
-The formation of anti-drug antibodies (ADA) to rhIL-7-hyFc will be evaluated: BioAgilytix will perform both Elisa Binding (non-neutralizing) and neutralizing antibody assays according to their Standard Operating Procedure.
Phase I: Absolute lymphocyte count (ALC)
Phase I and Randomized Phase II: Immunogenicity as measured by neutralizing anti-drug antibodies
-The formation of neutralizing anti-drug antibodies (NADA) to rhIL-7-hyFc will be evaluated: BioAgilytix will perform both Elisa Binding (non-neutralizing) and neutralizing antibody assays according to their Standard Operating Procedure.

Full Information

First Posted
September 25, 2018
Last Updated
July 20, 2023
Sponsor
Washington University School of Medicine
Collaborators
NeoImmuneTech, The Foundation for Barnes-Jewish Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03687957
Brief Title
rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temzolomide
Official Title
Effect of rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temzolomide
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
January 31, 2030 (Anticipated)
Study Completion Date
January 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
NeoImmuneTech, The Foundation for Barnes-Jewish Hospital

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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators have developed a phase I/II clinical trial to evaluate the effect of rhIL-7-hyFc on lymphocyte counts in patients with high grade glioma (HGG). A phase I study will test whether rhIL-7-hyFc can be safely administered to patients with HGG. Six doses of rhIL-7-hyFc will be tested using a mix of Accelerated Phase and standard 3+3 dose-escalation design. The phase II portion to test effect of rhIL-7-hyFc on lymphocyte counts will use placebo-controlled randomization in HGG patients whose treatment include the standard radiation therapy (RT) and temozolomide (TMZ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
-Phase I enrollment will be a sequential enrollment (patients will be stratified by concomitant use of steroids (yes/no). Phase II randomized portion will open with 2 arms being enrolled to in parallel. Phase II expansion cohort will not be randomized.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Phase II only: This study is triple-blinded (participant, physician, and study coordinator are all blinded; pharmacist and study statistician are not blinded)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase I: rhIL-7-hyFc
Arm Type
Experimental
Arm Description
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Arm Title
Randomized Phase II: Placebo
Arm Type
Experimental
Arm Description
-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.
Arm Title
Randomized Phase II: rhIL-7-hyFc
Arm Type
Experimental
Arm Description
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
Arm Title
Phase II Expansion Arm: rhIL-7-hyFc
Arm Type
Experimental
Arm Description
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
Intervention Type
Drug
Intervention Name(s)
rhIL-7-hyFc
Intervention Description
-Given by intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
-Given by intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
TMZ
Intervention Description
-Standard of care
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Other Intervention Name(s)
RT
Intervention Description
-Standard of care
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Description
Week 1 (prior to the 1st dose of rhIL-7-hyFc) Week 2 (one week after rhIL-7-hyFc) Week 3 (two weeks after rhIL-7-hyFc) Week 4 (three weeks after rhIL-7-hyFc) Week 13 (prior to the 2nd dose of rhIL-7-hyFc) Week 14 (one week after rhIL-7-hyFc) Week 16 (three weeks after rhIL-7-hyFc) - optional Week 45 (eight weeks after the last dose of rhIL-7-hyFC) If ADA or NADA is observed in week 45, additional blood collections will be required every 2 months in order to monitor ADA/NADA levels until it decreases to the basal level At the time of tumor progression
Primary Outcome Measure Information:
Title
Phase I: Safety and tolerability of rhIL-7-hyFc as measured by the maximum tolerated dose (MTD) - Phase I only
Description
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the non-tolerated dose. A total of at least 6 patients must be treated at a dose level for it to be considered the MTD.
Time Frame
Completion of enrollment of phase I portion of study (estimated to be 1 year)
Title
Phase I: Safety and tolerability of rhIL-7-hyFc as measured by dose-limiting toxicities (DLTs)
Description
-DLT will be defined as ≥ grade 3 non-dermatological and non-hematological AEs that occur within 30 days from the date when patients receive the 1st dose of rhIL-7-hyFc administration and are concluded to be possibly, likely or definitely related to the drug regimen that occurs during cycle 1, with severity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Time Frame
30 days from the date when patients receive the 1st dose of rhIL-7-hyFc administration (estimated to be 29 weeks)
Title
Randomized Phase II: Percent increase of absolute lymphocyte count
Time Frame
Prior to adjuvant TMZ (approximately week 4)
Title
Phase II Expansion Cohort: Progression-free survival (PFS)
Description
-Defined from date of surgery to date of progression or death due to disease or date of last clinical follow up.
Time Frame
Through completion of follow-up (estimated to be 5 years and 6 months)
Secondary Outcome Measure Information:
Title
Phase I and Randomized Phase II: Immunogenicity as measured by anti-drug antibodies
Description
-The formation of anti-drug antibodies (ADA) to rhIL-7-hyFc will be evaluated: BioAgilytix will perform both Elisa Binding (non-neutralizing) and neutralizing antibody assays according to their Standard Operating Procedure.
Time Frame
Baseline through Week 14
Title
Phase I: Absolute lymphocyte count (ALC)
Time Frame
1 year
Title
Phase I and Randomized Phase II: Immunogenicity as measured by neutralizing anti-drug antibodies
Description
-The formation of neutralizing anti-drug antibodies (NADA) to rhIL-7-hyFc will be evaluated: BioAgilytix will perform both Elisa Binding (non-neutralizing) and neutralizing antibody assays according to their Standard Operating Procedure.
Time Frame
Baseline through Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: World Health Organization (WHO) grade III, grade IV, and high risk grade II gliomas that require RT and TMZ treatment. Phase 2 Expansion Cohort ONLY: Must be IDH1 wildtype, as defined by negative immunohistochemistry using an R132H-specific antibody and MGMT promoter unmethylated glioblastoma multiforme (WHO grade IV). Post-operative treatment must have included radiation and TMZ. Prior Gliadel Wafers are allowed. Glucocorticoid therapy is allowed. Tumor treating fields (TTF) device is allowed. Adequate organ and marrow function defined as follows: Absolute neutrophil count ≥ 1,000/mcL Platelets ≥ 75,000/mcL Hemoglobin ≥ 8 g/dL Total bilirubin ≤ 3.0 x institutional upper limit of normal AST (SGOT)/ALT (SGPT) ≤ 3.0 × institutional upper limit of normal Absolute lymphocyte count (ALC) ≥ 600/mcL (required for phase I and randomized phase II only) Karnofsky Performance Status (KPS) ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others). Able to provide written informed consent (or consent from a legally authorized representative). Women of childbearing potential must have a negative serum pregnancy test prior to study entry (within 14 days). Patients must be willing to be on adequate contraception during treatment. 18 years of age. Exclusion Criteria: Receiving any other investigational agents which may affect patient's lymphocyte counts. Pregnant women are excluded from this study because rhIL-7-hyFc has not been evaluated regarding its potential for teratogenic or abortifacients effects. There is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug, breastfeeding should be discontinued if the mother is treated with rhIL-7-hyFc. Has an active viral infection requiring systemic treatment at screening. Has active autoimmune disease or syndrome (i.e. moderate or severe rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.,) that requires systemic treatment at the time of screening. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Subjects are permitted to enroll if they have vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. Receipt of live attenuated vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), Zoster, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed. Has clinically significant cardiac enzymes ([Tnl or TnT] or CK-MD) Patients with a clinically significant EKG on screening triggering a echocardiogram which is also clinically significant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Milan Chheda, M.D.
Phone
314-747-2712
Email
mchheda@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milan Chheda, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Withdrawn
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milan Chheda, M.D.
Phone
314-747-2712
Email
mchheda@wustl.edu
First Name & Middle Initial & Last Name & Degree
Milan Chheda, M.D.
First Name & Middle Initial & Last Name & Degree
George Ansstas, M.D.
First Name & Middle Initial & Last Name & Degree
Jiayi Huang, M.D.
First Name & Middle Initial & Last Name & Degree
Tanner Johanns, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Richard Hotchkiss, M.D.
First Name & Middle Initial & Last Name & Degree
John DiPersio, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Sonika Dahiya, M.D.
First Name & Middle Initial & Last Name & Degree
Omar Butt, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35031547
Citation
Campian JL, Ghosh S, Kapoor V, Yan R, Thotala S, Jash A, Hu T, Mahadevan A, Rifai K, Page L, Lee BH, Ferrando-Martinez S, Wolfarth AA, Yang SH, Hallahan D, Chheda MG, Thotala D. Long-Acting Recombinant Human Interleukin-7, NT-I7, Increases Cytotoxic CD8 T Cells and Enhances Survival in Mouse Glioma Models. Clin Cancer Res. 2022 Mar 15;28(6):1229-1239. doi: 10.1158/1078-0432.CCR-21-0947.
Results Reference
derived
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temzolomide

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