Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Cord Blood Transplant
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|ClinicalTrials.gov Identifier: NCT03941769|
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : March 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Cord Blood Transplant Recipient Myelodysplastic Syndrome Myeloproliferative Neoplasm||Biological: Recombinant Interleukin-7||Phase 1|
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]).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase I Study of Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Cord Blood Transplantation|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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
Given IM or SC
- Incidence of dose limiting toxicity [ Time Frame: Up to 42 days after first injection ]Will be defined as any of the events: 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.
- Maximum tolerated dose [ Time Frame: Up to 42 days after first injection ]Bayesian model averaging-continual reassessment method will be applied to determine an optimal recommended dose of CYT107.
- Rate of viral infections [ Time Frame: Up to 3 years ]Will determine the rate of cytomegalovirus, Epstein-Barr virus, and BK viral infections in cord blood transplant patients who receive three doses of CYT107 following engraftment.
- Overall survival [ Time Frame: Up to 3 years ]Will be estimated using the method of Kaplan and Meier.
- Progression-free survival [ Time Frame: Up to 12 months from the start of therapy ]Will be estimated using the method of Kaplan and Meier.
- Cumulative incidence of GVHD [ Time Frame: Up to 3 years ]
- Cumulative incidence of relapse [ Time Frame: Up to 3 years ]
- T, natural killer (NK), and B cell populations [ Time Frame: Up to 3 years ]Effects of CYT107 on the recovery of T, NK, and B cell populations and their functions in vitro will be evaluated.
- CYT107 blood levels [ Time Frame: Prior to first CYT107 injection and 1, 3, 5, 7, 9, and 24 hours after first injection ]CYT107 blood levels will be submitted to a Model-independent pharmacokinetic analysis allowing to estimate time to maximum concentration, concentration maximum, half-life, clearance and area-under-the-curve.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941769
|Contact: David Marinemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Contact: David Marin 713-792-8750|
|Principal Investigator: David Marin|
|Principal Investigator:||David Marin||M.D. Anderson Cancer Center|