Recombinant Human Interleukin-7 (CYT107) to Promote T-Cell Recovery After Cord Blood Transplantation

NCT03600896 | Withdrawn Phase 1 FDA Drug

• 3 other identifiers: 2015-04142R01CA061508-21NCI-2018-01750
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Participant is being asked to take part in this study because participant received an umbilical cord blood transplant as part of participant's standard treatment. Umbilical cord blood is a source of blood-forming cells that can be used for transplantation, also known as a graft. The problem with this type of transplant is the small number of blood-forming cells available in cord blood transplants, which may delay the "take" of the graft in the transplant recipient. There are 2 parts to this study. The goal of Part 1 of this clinical research study is to learn if it is safe and practical to give recombinant human interleukin-7 (CYT107) to patients who have received a cord blood transplant. Researchers want to learn if CYT107 affects the "take" of the graft and the recovery of certain blood cells related to the immune system (called T-cells, NK cells, and B cells) in patients who have had a cord blood transplant. The goal of Part 2 of this study is to learn if CYT107 may prevent or reduce the effects of graft-versus host disease (GVHD) or the likelihood of developing infections (such as cytomegalovirus \[CMV\], Epstein-Barr virus \[EBV\], and BK virus). GVHD happens when transplanted donor tissue attacks the tissues of the recipient's body. This is an investigational study. CYT107 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how CYT107 is designed to work. Up to 34 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

Umbilical Cord Blood Transplant

Keywords

Umbilical Cord Blood Transplant; Recombinant human interleukin-7; CYT107; T-Cell Recovery after Cord Blood Transplantation; CBT

Outcome Measures

Primary Outcomes (3)

• Toxicity of Recombinant Human Interleukin-7 (CYT107) defined as any of the events grade 3 or 4 GVHD, secondary graft failure, death, or grade 4 organ failure

  Within 42 days of the first injection

• Effects of Patient Covariates Variables on the Immune Reconstitution Parameters

  Longitudinal Bayesian model used to assess the effects of patient covariates variables on the immune reconstitution parameters.

  Baseline up to 1 year post-IL-7

• Rate of Viral Infections in CBT Patients Who Received Three Doses of CYT107 Following Engraftment

  The observed rates of virus infections evaluated by tabulation and Bayesian regression modeling.

  3 weeks

Secondary Outcomes (2)

• Secondary Graft Failure

  After CYT107 given up to one year

• Effects of Patient Treatment Variables on the Immune Reconstitution Parameters

  Baseline up to 1 year post-IL-7

Study Arms (2)

Phase 1: Recombinant Human Interleukin-7 (CYT107)

EXPERIMENTAL

In Part 1 of the study, 3 dose levels of CYT107 will be tested in this study. Up to 3 participants will be enrolled in each dose level. The first group of participants will receive the lowest dose level. The next group will receive a higher dose than the first group, if no intolerable side effects were seen. The third group will receive an even higher dose than the second, if no intolerable side effects were seen. Based on the results seen, 1 of the 3 doses will be selected as the recommended dose. In Part 2 of the study, an additional 25 participants will be enrolled to receive CYT107 at the recommended dose found in Part 1.

Drug: CYT107

Phase 2: Recombinant Human Interleukin-7 (CYT107)

EXPERIMENTAL

In Part 2 of the study, an additional 25 participants will be enrolled to receive CYT107 at the recommended dose found in Part 1.

Drug: CYT107

Interventions

CYT107 DRUG

Phase I: Patients will be treated with CYT107 post CBT (from 60 to 180 days), in with 1 of 3 doses below: * 5 mcg/kg/dose for 3 doses * 10 mcg/kg/dose for 3 doses * 20 mcg/kg/dose for 3 doses The optimal recommended dose determined in Phase I will be used to treat all patient enrolled in Phase II.

Also known as: Recombinant Human Interleukin-7

Phase 1: Recombinant Human Interleukin-7 (CYT107); Phase 2: Recombinant Human Interleukin-7 (CYT107)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 18 years old or older.
• Patient post a cord blood transplant (CBT) with documented absolute neutrophil engraftment and no evidence of GVHD or no history of acute or chronic GVHD requiring systemic steroids.
• Patients with documented engraftment but require granulocyte colony-stimulating factor (G-CSF) for myelosuppressive antibiotics or antiviral medications are eligible.
• Karnofsky performance status (KPS) \> 60%.
• Adequate organ function: Pulmonary: Absence of dyspnea or hypoxia (\< 90% of saturation by pulse oximetry on room air).
• Hepatic: Bilirubin \</= 1.5 X ULN, AST (SGOT) and /or ALT (SGPT) \</= 2.5 X ULN. PT/PTT \< 1.5 X ULN.
• Renal: Calculated Creatinine clearance \> 60 mL/min/1.73 m2.
• Diagnosis of acute myeloid leukemia; myelodysplastic syndrome; chronic myeloid leukemia or myeloproliferative disease.

You may not qualify if:

• Pregnant or nursing.
• History of lymphoid malignancy (including Hodgkin disease, non-Hodgkin lymphoma, Acute Lymphoblastic Leukemia and Chronic Lymphocytic Leukemia) or acute biphenotypic leukemia.
• History of EBV associated lymphoproliferation.
• Active uncontrolled viral, bacterial or fungal infection.
• EBV viremia equal to or greater than 500 copies EBV DNA/mL of blood by quantitative PCR.
• History of autoimmune disease.
• Receiving systemic corticosteroid therapy.
• Receiving concurrent treatment with another investigational drug and/or biological agent.
• Receiving anticoagulant therapy.
• Uncontrolled hypertension.
• QTc prolongation (QTc \> 470 ms) or prior history of significant arrhythmia or ECG abnormalities.
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Revimmune: collaborator

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Interleukin-7

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• David Marin, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 26, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: January 10, 2019

Record last verified: 2019-01