Refractory Acute Leukemia Clinical Trial
Official title:
Phase I/II Trial of VELCADE® (Bortezomib) in Combination With Mitoxantrone and Etoposide for Relapsed or Refractory Acute Leukemias
Based on what is known about it's mechanism of action, bortezomib is presumed to make other chemotherapy drugs work better. This study examines the use of bortezomib in combination with an already effective chemotherapy regimen that is used to treat leukemias that have relapsed or been refractory to treatment.
VELCADE is a drug that blocks growth of cancer cells and helps destroy them. This research
will help us to determine if VELCADE when combined with chemotherapy is useful in treating
the leukemia with which you have been diagnosed. Your leukemia is a type that did not respond
to chemotherapy or has come back after successful therapy.
VELCADE is approved by the Food and Drug Administration (FDA) for the treatment of multiple
myeloma for patients that have received at least one prior therapy. Multiple Myeloma is a
type of cancer that develops from blood cells. The dose of the drug being used in this
research study is the same as what is used for the treatment of myeloma but the number of
injections is less. VELCADE has, however not been approved by the FDA for use in acute
leukemia. Mitoxantrone and etoposide, the other two chemotherapy drugs are also used for
treating leukemia.
In the first part of the study, we are going to test the safety of VELCADE at different doses
when given with mitoxantrone and etoposide. You may be enrolled at any one of three doses. In
the second part, we are going to assess the response to the combination of VELCADE and
chemotherapy drugs. You will receive VELCADE at the chosen dose based on safety assessment
from Phase I. It will be administered as an intravenous (through the vein) injection on day-1
and day-4 of the 5-day schedule. In addition, you will also receive mitoxantrone over 15
minutes and etoposide over 45 minutes from days 1-5. The first 28 days from the beginning of
the treatment will be called a treatment cycle.
On day-14 of the treatment cycle, you will have a bone marrow biopsy done to see if all the
leukemia cells have disappeared. If there is no evidence of leukemia, then you may receive
growth factors to help your marrow recover faster. If there is still presence of leukemia, in
the same amount or more, then the treatment will be considered a failure and you will not
receive any more of this treatment.
If there is a partial improvement then you will receive additional cycles of VELCADE with
chemotherapy as described above until there are no signs of your disease. This is called a
complete remission.
Therapy will be withheld at any time if there is concern that you are having side-effects
that are not medically acceptable. Once the side-effects have resolved, VELCADE therapy may
be re-started at a lower dose.
It is estimated that you may require about two to three cycles of therapy.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01701375 -
A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia
|
Phase 1 | |
| Active, not recruiting |
NCT05029141 -
New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 2 | |
| Not yet recruiting |
NCT06397027 -
A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias
|
Phase 1 | |
| Active, not recruiting |
NCT03834961 -
Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia
|
Phase 2 | |
| Recruiting |
NCT00984412 -
Allo-Allo Tandem Bone Marrow Transplant (BMT)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04681105 -
Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies
|
Phase 1 | |
| Completed |
NCT03735875 -
Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06466395 -
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias
|
Phase 1 |