Symptoms and General Pathology

All Conditions

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Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Myeloproliferative Disorders

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

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Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

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

Recombinant Interleukin-7

Gheath Al-Atrash

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.

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.

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

A Phase I/II Study of Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Haploidentical and Cord Blood Stem Cell Transplantation

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.

Number of participant that survived after 3 years.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

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

Recombinant Interleukin-7: Given IM or SC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II	NCT03941769	Acute Myeloid L... Chronic Myeloge... Cord Blood Tran... Myelodysplastic... Myeloproliferat...	Recombinant Int...	18 Years -	M.D. Anderson Cancer Center
2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II	NCT03941769	Acute Myeloid L... Chronic Myeloge... Cord Blood Tran... Myelodysplastic... Myeloproliferat...	Recombinant Int...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for cord blood transplant recipient