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Report for Clinical Trial NCT01887587

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I Study Of Vincristine, Doxorubicin, And Dexamethasone (VXD) Plus Ixazomib In Adults With Relapsed Or Refractory Acute Lymphoblastic Leukemia/Lymphoma, Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia

This is a phase I study of vincristine, doxorubicin and dexamethasone (modified VXD) plus MLN9708 in adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma, lymphoblastic lymphoma or mixed phenotype acute leukemia.

NCT01887587 Relapsed or Refractory Acute Lymphoblastic Leukemia Relapsed or Refractory Lymphoblastic Lymphoma Mixed Phenotype Acute Leukemia
MeSH:Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, Non-Hodgkin Acute Disea Acute Disease
HPO:Leukemia Lymphoid leukemia Lymphoma Non-Hodgkin lymphoma

4 Interventions

Name: MLN9708

Type: Drug
Group Labels: 1

(modified VXLD) plus MLN9708

Name: Vincristine

Type: Drug
Group Labels: 1

(modified VXLD) plus MLN9708

Name: Doxorubicin

Type: Drug
Group Labels: 1

(modified VXLD) plus MLN9708

Name: Dexamethasone

Type: Drug
Group Labels: 1

(modified VXLD) plus MLN9708

Primary Outcomes

Description: Safety, tolerability will be assessed by counting the number of participants experiencing adverse events at 8 weeks post treatment.

Measure: Adverse Events.

Time: Baseline to 30 days post treatment; approximately 8 weeks

Description: This measure will be the maximum tolerated dose (MTD) at which no more than 1 Dose Limiting Toxicity (DLT) is observed. The starting dose of MLN9708 will be 2.3 mg orally on days 1, 8 and 15. If no DLT is seen in the first 3 patients, the dose will be increased to 3 mg and then to 4 mg orally on days 1, 8 and 15 in a classic 3 +3 phase I design. We will not attempt to increase the dose beyond 4 mg orally which, if achieved with acceptable toxicity, would be accepted as the recommended phase 2 dose (RP2D). 0 of 3 DLTs would allow escalation to the next dose level. 1 of 3 DLTs will require expanding to six patients; 1 of 6 DLTs will allow escalation again. 2 DLTs will require dose de-escalation.

Measure: Optimal Dose of MLN9708

Time: 8 Weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 P4503A

- Systemic treatment, within 7 days before study enrollment, with strong inhibitors of cytochrome P450 1A2 (CYP1A2) (e.g., fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of cytochrome P4503A (CYP3A) (e.g., clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort. --- P4503A ---

HPO Nodes