Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Cord Blood Transplant Recipient Myelodysplastic Syndrome Myeloproliferative Neoplasm | Biological: Recombinant Interleukin-7 | Phase 1 |
PRIMARY OBJECTIVES:
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]).
SECONDARY OBJECTIVES:
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 |
Allocation: | N/A |
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 |
Actual Study Start Date : | September 29, 2020 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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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.
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Biological: Recombinant Interleukin-7
Given IM or SC
Other Names:
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gheath Al-Atrash | 713-563-3324 | galatras@mdanderson.org |
United States, Texas | |
M D Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: David Marin 713-792-8750 | |
Principal Investigator: David Marin |
Principal Investigator: | Gheath Al-Atrash | M.D. Anderson Cancer Center |
Tracking Information | |||||
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First Submitted Date ICMJE | May 6, 2019 | ||||
First Posted Date ICMJE | May 8, 2019 | ||||
Last Update Posted Date | April 20, 2021 | ||||
Actual Study Start Date ICMJE | September 29, 2020 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Cord Blood Transplant | ||||
Official Title ICMJE | A Phase I Study of Recombinant Human Interleukin-7 to Promote T-Cell Recovery After Cord Blood Transplantation | ||||
Brief Summary | This phase I 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 cord blood transplant. 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 cord blood transplant. | ||||
Detailed Description |
PRIMARY OBJECTIVES: 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]). SECONDARY OBJECTIVES: 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE | Biological: Recombinant Interleukin-7
Given IM or SC
Other Names:
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Study Arms ICMJE | 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.
Intervention: Biological: Recombinant Interleukin-7
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
21 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03941769 | ||||
Other Study ID Numbers ICMJE | 2018-0674 NCI-2019-02124 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0674 ( Other Identifier: M D Anderson Cancer Center ) R01CA061508 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | April 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |