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Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Cord Blood Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03941769
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : December 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This phase I 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 cord blood transplant. 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 cord blood transplant.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Cord Blood Transplant Recipient Myelodysplastic Syndrome Myeloproliferative Neoplasm Biological: Recombinant Interleukin-7 Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the safety and establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of recombinant interleukin-7 (interleukin 7 [IL-7, CYT107]).

SECONDARY OBJECTIVES:

I. To determine the rate of cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK viral infections in cord blood transplant (CBT) patients who receive three doses of IL-7 following engraftment.

II. To calculate the overall survival (OS), progression-free survival (PFS), and cumulative incidence of graft versus host disease (GVHD) and cumulative incidence of relapse.

III. To evaluate the effects of CYT107 on the recovery of T, natural killer (NK) and B cell populations and their functions in vitro; these data will be used to identify the optimal dose to move to a phase II trial.

IV. To obtain information about the pharmacokinetic (PK) profile of CYT107 by estimating time to maximum concentration (Tmax), concentration maximum (Cmax), half-life, clearance and area-under-the-curve (AUC).

OUTLINE: This is a dose-escalation study.

Within 60-180 days after CBT, patients receive recombinant interleukin-7 intramuscularly (IM) or subcutaneously (SC) once per week for 3 weeks.

After completion of study treatment, patients are followed for up to 3 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase I Study of Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Cord Blood Transplantation
Estimated Study Start Date : February 28, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Supportive care (recombinant interleukin-7)
Within 60-180 days after CBT, patients receive recombinant interleukin-7 IM or SC once per week for 3 weeks.
 Biological: Recombinant Interleukin-7
Given IM or SC
Other Names:
  • CYT 99 007
  • CYT-107
  • IL-7
  • Lymphopoietin-1
  • Recombinant Human Interleukin-7


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose limiting toxicity [ Time Frame: Up to 42 days after first injection ]
    Will be defined as any of the events: 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.

  2. Maximum tolerated dose [ Time Frame: Up to 42 days after first injection ]
    Bayesian model averaging-continual reassessment method will be applied to determine an optimal recommended dose of CYT107.


Secondary Outcome Measures :
  1. Rate of viral infections [ Time Frame: Up to 3 years ]
    Will determine the rate of cytomegalovirus, Epstein-Barr virus, and BK viral infections in cord blood transplant patients who receive three doses of CYT107 following engraftment.

  2. Overall survival [ Time Frame: Up to 3 years ]
    Will be estimated using the method of Kaplan and Meier.

  3. Progression-free survival [ Time Frame: Up to 12 months from the start of therapy ]
    Will be estimated using the method of Kaplan and Meier.

  4. Cumulative incidence of GVHD [ Time Frame: Up to 3 years ]
  5. Cumulative incidence of relapse [ Time Frame: Up to 3 years ]
  6. T, natural killer (NK), and B cell populations [ Time Frame: Up to 3 years ]
    Effects of CYT107 on the recovery of T, NK, and B cell populations and their functions in vitro will be evaluated.

  7. CYT107 blood levels [ Time Frame: Prior to first CYT107 injection and 1, 3, 5, 7, 9, and 24 hours after first injection ]
    CYT107 blood levels will be submitted to a Model-independent pharmacokinetic analysis allowing to estimate time to maximum concentration, concentration maximum, half-life, clearance and area-under-the-curve.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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) 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 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
  • History of Epstein-Barr virus (EBV) associated lymphoproliferation
  • Active uncontrolled viral, bacterial or fungal infection
  • Documented human immunodeficiency virus (HIV)-1 or -2, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection at any time before or after transplant. (A positive hepatitis B serology indicative of a previous immunization is not an exclusion criteria)
  • EBV viremia equal to or greater than 500 copies EBV deoxyribonucleic acid (DNA)/mL of blood by quantitative polymerase chain reaction (PCR)
  • Positive cytomegalovirus (CMV) antigenemia
  • History of autoimmune disease
  • Receiving systemic corticosteroid therapy
  • Receiving concurrent treatment with another investigational drug and/or biological agent
  • Receiving anticoagulant therapy
  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941769


Contacts
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Contact: David Marin 713-792-8750 dmarin@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: David Marin    713-792-8750      
Principal Investigator: David Marin         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David Marin M.D. Anderson Cancer Center
More Information
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Additional Information:
MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03941769    
Other Study ID Numbers: 2018-0674
NCI-2019-02124 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0674 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
R01CA061508 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Myeloproliferative Disorders
Neoplasms by Histologic Type
 Neoplasms
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases