CompletedNCT03941769Updated Oct 17, 2024Results posted

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

A Phase 1/2 interventional study of Recombinant Interleukin-7 in Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Cord Blood Transplant Recipient, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by M.D. Anderson Cancer Center · Phase 1/2, Interventional, and Supportive care

Phase: Phase 1/2
Study type: Interventional
Enrollment: 1
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Acute Myeloid Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Cord Blood Transplant Recipient
Myelodysplastic Syndrome
Myeloproliferative Neoplasm

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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 1 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

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Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 1 participant (actual)

Study arms

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

Interventions

BiologicalRecombinant Interleukin-7
Given IM or SC
Also known as: CYT 99 007, CYT-107, IL-7, Lymphopoietin-1, Recombinant Human Interleukin-7

What researchers measure

Primary outcomes

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.
Time frame: Up to 42 days after first injection

Secondary outcomes

Overall Survival
Number of participant that survived after 3 years.
Time frame: Up to 3 years

Results

Posted Aug 1, 2023

Participant flow

Recruitment was done at The University of Texas MD Anderson Cancer Center.

Participant flow — Overall Study
Milestone	Supportive Care (Recombinant Interleukin-7)
Started	1
Completed	1
Not completed	0

Outcome measures

PrimaryNumber 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.

Time frame:: Up to 42 days after first injection
Reported as:: Count of participants · Participants

Number of Participants With Dose Limiting Toxicities
Participants	Supportive Care (Recombinant Interleukin-7)
Number of Participants With Dose Limiting Toxicities	0

SecondaryOverall Survival

Number of participant that survived after 3 years.

Time frame:: Up to 3 years
Reported as:: Count of participants · Participants

Overall Survival
Participants	Supportive Care (Recombinant Interleukin-7)
Overall Survival	0

Adverse events

Collected over 42 days from the last injection of CYT107, up to 3 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Supportive Care (Recombinant Interleukin-7)	1/1 (100%)	0/1 (0%)	1/1 (100%)

Most frequent other events

Most frequent other events
Event	Supportive Care (Recombinant Interleukin-7)
White blood cell decreasedInvestigations	1/1
Increased ALTGeneral disorders	1/1
Urinary Tract InfectionInfections and infestations	1/1
FallInjury, poisoning and procedural complications	1/1
ANC DecreasedInfections and infestations	1/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Supportive Care (Recombinant Interleukin-7)
<=18 years	0
Between 18 and 65 years	1
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	Supportive Care (Recombinant Interleukin-7)
Female	1
Male	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Supportive Care (Recombinant Interleukin-7)
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	1
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Supportive Care (Recombinant Interleukin-7)
United States	1

Study locations

1 site

M D Anderson Cancer Center
Houston, Texas 77030, United States

References and documents

Study documents

Protocol and statistical analysis plan · Sep 9, 2022
Informed consent form · Aug 31, 2022

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03941769
Lead sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: May 8, 2019
Start date: Sep 29, 2020
Primary completion: Mar 1, 2023
Completion: Mar 1, 2023
Results posted: Aug 1, 2023
Last update: Oct 17, 2024

Study contacts

Gheath Al-Atrash

principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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