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

NCT03941769 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 2018-0674NCI-2019-02124R01CA061508
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 42 days after first injection

Secondary Outcomes (1)

• Overall Survival

  Up to 3 years

Study Arms (1)

Supportive care (recombinant interleukin-7)

EXPERIMENTAL

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

Recombinant Interleukin-7 BIOLOGICAL

Given IM or SC

Also known as: CYT 99 007, CYT-107, IL-7, Lymphopoietin-1, Recombinant Human Interleukin-7

Supportive care (recombinant interleukin-7)

Eligibility Criteria

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

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

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

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes; Myeloproliferative Disorders

Interventions

Interleukin-7

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gheath Al-Atrash, M.D. / Stem Cell Transplantation
• Organization: The University of Texas MD Anderson Cancer Center

galatras@mdanderson.org

713-792-7734

Study Officials

• Gheath Al-Atrash

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: September 29, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 17, 2024
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Locations

US (1)