Clinical trial · Interventional
2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II
A Phase I/II Study of Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Haploidentical and Cord Blood Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Cord Blood Transplant Recipient | — | UNRESOLVED | — |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myeloproliferative Neoplasm | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Interleukin-7 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (recombinant interleukin-7)
- description
- Within 60-180 days after CBT, patients receive recombinant interleukin-7 IM or SC once per week for 3 weeks.
- interventionNames
- Biological: Recombinant Interleukin-7
Primary outcomes (1)
- measure
- Number of Participants With Dose Limiting Toxicities
- timeFrame
- Up to 42 days after first injection
- description
- 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.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * English and non-English speaking patients are eligible. * Patient post a cord blood transplant (CBT) or haplo-SCT, with matched unrelated donors (MUDs), both peripheral blood (PB) and marrow sources with documented absolute neutrophil engraftment * Patients with documented engraftment but require granulocyte-colony stimulating factor (G-CSF) to treat myelosuppression induced by drugs used to treat or prevent infection are eligible * Karnofsky performance status (KPS) \> 60% * Absence of dyspnea or hypoxia (\< 90% of saturation by pulse oximetry on room air) * Bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and/or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN * Prothrombin time (PT)/partial prothrombin time (PTT) \< 1.5 x ULN * Calculated creatinine clearance \> 60 mL/min/1.73 m\^2 * Diagnosis of acute myeloid leukemia; myelodysplastic syndrome; chronic myeloid leukemia; myelofibrosis or myeloproliferative disease Exclusion Criteria: * Pregnant or nursing * History of lymphoid malignancy (including Hodgkin disease, non-Hodgkin lymphoma, acute lymphoblastic leukemia and chronic lymphocytic leukemia) or acute biphenotypic leukemia * Patients with acute GVHD \> grade 2 at any time during the post-transplant course * Ongoing immunosuppressive therapy for the treatment of GVHD. Patients receiving GVHD prophylaxis will be allowed on this study * History of Epstein-Barr virus (EBV) associated lymphoproliferation * Active uncontrolled viral, bacterial or fungal infection * History of autoimmune disease * Receiving systemic corticosteroid therapy, budesonide is allowed * Uncontrolled hypertension * Corrected QT (QTc) prolongation (QTc \> 470 ms) or prior history of significant arrhythmia or electrocardiogram (ECG) abnormalities * Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements * Patients with cognitive impairments and/or any past or current psychiatric illness that, in the opinion of the investigator, would interfere with adherence to study requirements or the ability and willingness to give written informed consent
References
Publications (0)
Data not yet available