Umbilical Cord Blood Transplant Clinical Trial
Official title:
Recombinant Human Interleukin-7 (CYT107) to Promote T-Cell Recovery After Cord Blood Transplantation
Participant is being asked to take part in this study because participant received an
umbilical cord blood transplant as part of participant's standard treatment. Umbilical cord
blood is a source of blood-forming cells that can be used for transplantation, also known as
a graft.
The problem with this type of transplant is the small number of blood-forming cells available
in cord blood transplants, which may delay the "take" of the graft in the transplant
recipient.
There are 2 parts to this study.
The goal of Part 1 of this clinical research study is to learn if it is safe and practical to
give recombinant human interleukin-7 (CYT107) to patients who have received a cord blood
transplant. Researchers want to learn if CYT107 affects the "take" of the graft and the
recovery of certain blood cells related to the immune system (called T-cells, NK cells, and B
cells) in patients who have had a cord blood transplant.
The goal of Part 2 of this study is to learn if CYT107 may prevent or reduce the effects of
graft-versus host disease (GVHD) or the likelihood of developing infections (such as
cytomegalovirus [CMV], Epstein-Barr virus [EBV], and BK virus). GVHD happens when
transplanted donor tissue attacks the tissues of the recipient's body.
This is an investigational study. CYT107 is not FDA approved or commercially available. It is
currently being used for research purposes only. The study doctor can explain how CYT107 is
designed to work.
Up to 34 participants will be enrolled in this study. All will take part at MD Anderson.
Study Groups:
If participant is found to be eligible to take part in this study and participant agrees,
participant will be assigned to a study group based on when participant joined this study.
In Part 1 of the study, 3 dose levels of CYT107 will be tested in this study. Up to 3
participants will be enrolled in each dose level. The first group of participants will
receive the lowest dose level. The next group will receive a higher dose than the first
group, if no intolerable side effects were seen. The third group will receive an even higher
dose than the second, if no intolerable side effects were seen. Based on the results seen, 1
of the 3 doses will be selected as the recommended dose.
In Part 2 of the study, an additional 25 participants will be enrolled to receive CYT107 at
the recommended dose found in Part 1.
Study Drug Administration:
Participant will be given one injection of CYT107 directly into the muscle 1 time each week
for 3 weeks. If the doctor thinks it is needed, participant may be able to receive CYT107 as
an injection under the skin instead of the muscle.
Participant will be given standard drugs to help decrease the risk of side effects.
Participant may ask the study staff for information about how the drugs are given and their
risks.
Length of Study Participation:
Participant may receive up to 3 injections of CYT107. Participant will no longer be able to
take the study drug if the disease gets worse, if intolerable side effects occur, or if
participant is unable to follow study directions.
Participation in this study will be over about 1 year after the last injection.
Study Visits:
One (1) time each week during Weeks 1-3:
- Participant will have a physical exam.
- Blood (about 4 teaspoons) will be drawn for routine tests.
Before each dose of CYT107 and then about 21, 28, and 100 days after the first injection,
blood (about 1 tablespoon each time) will be drawn to check your immune system function, to
check for infections, and to check the effects of CYT107 on participant's body.
One (1) time each week for about 6 months, blood (about 4 teaspoons) will be drawn to check
for CMV. Part of the blood may be used to check for EBV. If participant has symptoms of BK
infection during the study, blood (about 1 teaspoon) and urine will also be collected to
check for the BK virus.
Pharmacokinetic (PK) and Research Testing:
Blood (about 1 tablespoon each time) will be drawn for PK testing before participant's first
CYT107 injection and then 3 more times over the 24 hours after participant's first injection.
Blood will also be drawn after participant's last CYT107 injection. PK testing measures the
amount of study drug in the body at different time points.
Before the first CYT107 injection and on Day 42, blood (about 1 teaspoon each time) will be
drawn to test for anti-CYT107 antibodies. Antibodies are created by the immune system and may
attack foreign cells or substances, such as CYT107. If the test on Day 42 is positive, blood
(about 1 teaspoon) will be drawn on Day 100 to check for CYT107 antibodies. These blood
samples will be sent to the study supporter, Revimmune. After the samples are used for this
antibody testing, the samples will be destroyed.
Follow-Up:
After participant's last dose of CYT107, participant will continue to have follow-up visits
as part of participant's standard care (visits participant would have even if participant was
not taking part in this study) for up to 1 year after participant's last dose. Information
from these follow-up visits, such as results of any standard of care testing, will be
collected.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01247688 -
Umbilical Cord Blood Transplant for Children With Lymphoid Hematological Malignancies
|
N/A |