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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    21
  • sponsor
    M.D. Anderson Cancer Center
Updated on 31 July 2021
chronic myeloid leukemia
graft versus host disease
myeloid leukemia
myeloproliferative disorder
filgrastim
granulocyte colony stimulating factor
leukemia
colony stimulating factor

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.

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.

Details
Condition Bone marrow disorder, Preleukemia, Acute myeloid leukemia, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Chronic myeloid leukemia, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Myeloproliferative Neoplasms, Cord Blood Transplant Recipient, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, myelodysplastic syndrome (mds), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment Recombinant Interleukin-7
Clinical Study IdentifierNCT03941769
SponsorM.D. Anderson Cancer Center
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

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
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