Standard Maintenance POMP/D Plus Ixazomib Maintenance Therapy in Adult Patients With Acute Lympho… (NCT02578511) | Clinical Trial Compass
WithdrawnPhase 1
Standard Maintenance POMP/D Plus Ixazomib Maintenance Therapy in Adult Patients With Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma or Mixed Phenotype Acute Leukemia in Complete Remission (CR)
Stopped: No enrollment, another competing study and difficult to find the right person to enroll on this study.
United States0Started 2017-06-29
Plain-language summary
In this phase I study, escalating doses of IXAZOMIB will be combined with the POMP/D regimen.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Male or female patients 18 years or older.
* Have B-precursor, T cell ALL, MPAL or LBL in CR following therapy and receiving maintenance therapy. Patients with persistent minimal residual disease and/or in complete remission with incomplete platelet recovery are not eligible.
* Prior therapy: Should have achieved CR following the induction and intensification phases of treatment, with no limit on the number of prior treatment regimens, and started treatment with POMP/D maintenance. Patients who achieved CRp or CR with persistence of minimal residual disease are not eligible.
* Patients are eligible after allogeneic stem cell transplantation.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Patients must meet the following clinical laboratory criteria:
* Total bilirubin \< 1.5 X the upper limit of the normal range (ULN).
* Alanine aminotransferase (ALT) and aspartate aminotransferase. (AST) \< 3 X ULN.
* Calculated creatinine clearance \> 30 mL/min.
* Absolute neutrophil count (ANC) \> 1,000/cmm and platelets \> 75,000/cmm.
* Patient has a life expectancy of at least six months.
* Patients must be at least two weeks from major surgery, radiation therapy, participation in other investigational trials and have recovered from clinically significant toxicities of these prior treatments.
* Patients should be on stable doses of 6-mercaptopurine, methotrexate, vincristine and prednisone/dexamethasone as part of the POMP/D regimen, …
What they're measuring
1
Maximum tolerated dose of ixazomib with POMP/D maintenance