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

Primary Purpose

Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Cord Blood Transplant Recipient

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Recombinant Interleukin-7
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (recombinant interleukin-7)

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicities
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 Outcome Measures

Overall Survival
Number of participant that survived after 3 years.

Full Information

First Posted
May 6, 2019
Last Updated
July 28, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03941769
Brief Title
2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II
Official Title
A Phase I/II Study of Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Haploidentical and Cord Blood Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety and establish the optimal biologic dose of glycosylated recombinant human interleukin-7 (CYT107). SECONDARY OBJECTIVES: I. To determine the rate of cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK viral infections in umbilical cord blood stem cell transplantation (CBT) and haploidentical stem cell transplantation (haplo-SCT) patients who receive three doses of interleukin-7 (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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Cord Blood Transplant Recipient, Myelodysplastic Syndrome, Myeloproliferative Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (recombinant interleukin-7)
Arm Type
Experimental
Arm Description
Within 60-180 days after CBT, patients receive recombinant interleukin-7 IM or SC once per week for 3 weeks.
Intervention Type
Biological
Intervention Name(s)
Recombinant Interleukin-7
Other Intervention Name(s)
CYT 99 007, CYT-107, IL-7, Lymphopoietin-1, Recombinant Human Interleukin-7
Intervention Description
Given IM or SC
Primary Outcome Measure Information:
Title
Number of Participants With Dose Limiting Toxicities
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.
Time Frame
Up to 42 days after first injection
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Number of participant that survived after 3 years.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gheath Al-Atrash
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

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

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