Trial · NCT03687957
rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide
NCT03687957, Phase 1, Phase 2, Active not recruiting, Washington University School of Medicine; results first posted 2025-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide. Trials, record NCT03687957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03687957
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide
- NCT number
- NCT03687957
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Glioma
- Interventions
- rhIL-7-hyFc, Placebo, Temozolomide, Radiation therapy
- First posted
- 2018-09-27
- Last updated
- 2025-11-25
- Results first posted
- 2025-11-25
- Limitations and caveats
After completion of enrollment to the Phase I and Phase II Randomized portions of the trial, funding was depleted. Despite numerous attempts to gain new funding, the Phase II Expansion portion of the trial was never opened to enrollment. The results are late due to this reason.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I Only: Safety and Tolerability of rhIL-7-hyFc as Measured by the Maximum Tolerated Dose (MTD) of rhIL-7-hyFc | Within 30 days of treatment start | -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. |
| Primary | Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs) | Within 30 days of treatment start | -DLTs are defined in the protocol. |
| Primary | Randomized Phase II: Percent Change in Absolute Lymphocyte Count (ALC) | Baseline to Prior to adjuvant TMZ (approximately week 4) | Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system. |
| Primary | Phase II Expansion Arm: Progression-free Survival (PFS) | Through completion of follow-up (estimated to be 5 years and 6 months) | -Defined from date of surgery to date of progression or death due to disease or date of last clinical follow up. |
| Secondary | Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) | Week 1, Week 13, Week 25, and Week 45 | * 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. The data will be presented if anti-drug antibodies are detected or not detected in the samples. * Week 1 will be prior to injection of 1st dose of rhIL-7-hyFc, week 13 will be prior to the 2nd dose of rhIL-7-hyFc, and week 45 will be 8 weeks after the last dose of rhIL-7-hyFc. |
| Secondary | Phase I: Percent Change in Absolute Lymphocyte Count (ALC) | Baseline to Prior to adjuvant TMZ (approximately week 4) | Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I Only: Safety and Tolerability of rhIL-7-hyFc as Measured by the Maximum Tolerated Dose (MTD) of rhIL-7-hyFc | Within 30 days of treatment start | All Phase I participants are evaluable for this outcome measure. | mcg/kg | NUMBER |
| PRIMARY | Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs) | Within 30 days of treatment start | This outcome measure is for Phase I participants only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Randomized Phase II: Percent Change in Absolute Lymphocyte Count (ALC) | Baseline to Prior to adjuvant TMZ (approximately week 4) | Only participants in the Randomized Phase II Placebo and Randomized Phase II rhIL-7-hyFc are evaluable for this outcome measure. | percent change | MEDIAN |
| PRIMARY | Phase II Expansion Arm: Progression-free Survival (PFS) | Through completion of follow-up (estimated to be 5 years and 6 months) | The Phase II Expansion Arm of the trial never opened to enrollment and no participants were enrolled. | ||
| SECONDARY | Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) | Week 1, Week 13, Week 25, and Week 45 | Samples were not collected at all time points if a participant was removed from treatment or removed from the study prior to that timepoint. Week 25 was removed with amendment #4 and only one participant had a sample collected at this time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase I: Percent Change in Absolute Lymphocyte Count (ALC) | Baseline to Prior to adjuvant TMZ (approximately week 4) | Only Phase I participants are evaluable for this outcome measure. | percent change | MEDIAN |
Source ClinicalTrials.gov
Results by group79
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I Only: Safety and Tolerability of rhIL-7-hyFc as Measured by the Maximum Tolerated Dose (MTD) of rhIL-7-hyFc | Phase I: rhIL-7-hyFc All Dose Levels | 720 | mcg/kg | ||
| Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs) | Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) | 0 | Participants | ||
| Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs) | Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) | 0 | Participants | ||
| Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs) | Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) | 0 | Participants | ||
| Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs) | Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) | 0 | Participants | ||
| Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs) | Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) | 0 | Participants | ||
| Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs) | Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) | 2 | Participants | ||
| Randomized Phase II: Percent Change in Absolute Lymphocyte Count (ALC) | Randomized Phase II: Placebo | 16.66667 | Standard Deviation 28.36597 | percent change | |
| Randomized Phase II: Percent Change in Absolute Lymphocyte Count (ALC) | Randomized Phase II: rhIL-7-hyFc | 147.8261 | Standard Deviation 285.9597 | percent change | |
| Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) | Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) | Week 1 / Detected | 0 | Participants |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) | 1 | |
| Overall Study | STARTED | Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) | 1 | |
| Overall Study | STARTED | Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) | 3 | |
| Overall Study | STARTED | Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) | 6 | |
| Overall Study | STARTED | Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) | 6 | |
| Overall Study | STARTED | Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) | 2 | |
| Overall Study | STARTED | Randomized Phase II: Placebo | 11 | |
| Overall Study | STARTED | Randomized Phase II: rhIL-7-hyFc | 11 | |
| Overall Study | STARTED | Randomized Phase II: Not Randomized | 1 | |
| Overall Study | STARTED | Phase II Expansion Arm: rhIL-7-hyFc | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events846
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) | 0 | 1 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) | 0 | 1 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) | 0 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) | 1 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) | 0 | 2 | |
| other | Anemia | Blood and lymphatic system disorders | Randomized Phase II: Placebo | 0 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | Randomized Phase II: rhIL-7-hyFc | 0 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | Randomized Phase II: Not Randomized | 1 | ||
| other | Sinus tachycardia | Cardiac disorders | Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) | 0 | 1 |
1 to 10 of 846Source ClinicalTrials.gov
See all 846 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) | 1 | 1 |
| Total, all-cause mortality | Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) | 1 | 1 |
| Total, all-cause mortality | Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) | 1 | 3 |
| Total, all-cause mortality | Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) | 5 | 6 |
| Total, all-cause mortality | Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) | 5 | 6 |
| Total, all-cause mortality | Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) | 2 | 2 |
| Total, all-cause mortality | Randomized Phase II: Placebo | 9 | 11 |
| Total, all-cause mortality | Randomized Phase II: rhIL-7-hyFc | 10 | 11 |
| Total, all-cause mortality | Randomized Phase II: Not Randomized | 0 | 1 |
| Total, other adverse events | Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) | 1 | 1 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35031547 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03687957
GET https://conductscience.org/api/trials/v1/NCT03687957/results?page=2