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NCT03941769

2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II

Completed Phase 1, PHASE2 Results posted Last updated 17 October 2024
What this trial tests

Phase 1, PHASE2 trial testing Recombinant Interleukin-7 in Acute Myeloid Leukemia in 1 participant. Completed in 1 March 2023.

Timeline
29 September 2020
Primary endpoint
1 March 2023
1 March 2023

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment1
Start date29 September 2020
Primary completion1 March 2023
Estimated completion1 March 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia or Chronic Myelogenous Leukemia, BCR-ABL1 Positive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose Limiting Toxicities Primary · Up to 42 days after first injection

Participants that had grade 3 or 4 graft versus host disease (GVHD), secondary graft failure, disease relapse, development of post-transplant lymphoproliferative disorder, development of progressive multifocal leukoencephalopathy or grade 3-4 organ failure attributable to recombinant human interleukin-7 (CYT107) and death.

GroupValue95% CI
Supportive Care (Recombinant Interleukin-7)0
Overall Survival Secondary · Up to 3 years

Number of participant that survived after 3 years.

GroupValue95% CI
Supportive Care (Recombinant Interleukin-7)0

Adverse events — posted to ClinicalTrials.gov

Time frame: 42 days from the last injection of CYT107, up to 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Supportive Care (Recombinant Interleukin-7)
Serious: 0/1 (0%)
Deaths: 1/1
Other adverse events (5 terms — click to expand)

ReactionSystemSupportive Care (Recombina…
White blood cell decreasedInvestigations
Increased ALTGeneral disorders
Urinary Tract InfectionInfections and infestations
FallInjury, poisoning and procedural complications
ANC DecreasedInfections and infestations

Data from ClinicalTrials.gov NCT03941769 adverse events section.

Sponsor's own description

This phase I/II trial studies side effects and best dose of recombinant interleukin-7 in promoting immune cell recovery in patients with acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, or myeloproliferative disease after a haploidentical or cord blood stem cell transplant. A haploidentical transplant is a transplant that uses stem cells from a donor that is partially (at least 50%) matched to the patient. Umbilical cord blood is a source of blood-forming cells that can be used for transplant, also known as a graft. However, there is a small number of blood-forming cells available in the transplant, which may delay the "take" of the graft in the recipient. Recombinant interleukin-7 may affect the "take" of the graft and the recovery of certain blood cells related to the immune system (called T-cells, natural killer cells, and B cells) in patients who have had a haploidentical or cord blood stem cell transplant.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Inflammation in cancer: therapeutic opportunities from new insights.
    Xie Y, Liu F, Wu Y, Zhu Y, et al · · 2025 · cited 53× · PMID 39994787 · DOI 10.1186/s12943-025-02243-8
  2. Dynamics of thymus function and T cell receptor repertoire breadth in health and disease.
    Granadier D, Iovino L, Kinsella S, Dudakov JA. · · 2021 · cited 39× · PMID 33608819 · DOI 10.1007/s00281-021-00840-5
  3. The application of Interleukin-2 family cytokines in tumor immunotherapy research.
    Zhou Y, Quan G, Liu Y, Shi N, et al · · 2023 · cited 32× · PMID 36936961 · DOI 10.3389/fimmu.2023.1090311
  4. Harnessing the Power of IL-7 to Boost T Cell Immunity in Experimental and Clinical Immunotherapies.
    Park JH, Lee SW, Choi D, Lee C, et al · · 2024 · cited 19× · PMID 38455462 · DOI 10.4110/in.2024.24.e9
  5. Primary and secondary defects of the thymus.
    Dinges SS, Amini K, Notarangelo LD, Delmonte OM. · · 2024 · cited 14× · PMID 38228406 · DOI 10.1111/imr.13306
  6. The potential role of the thymus in immunotherapies for acute myeloid leukemia.
    Hino C, Xu Y, Xiao J, Baylink DJ, et al · · 2023 · cited 12× · PMID 36814919 · DOI 10.3389/fimmu.2023.1102517

Verify or expand the search:

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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