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COMPLETED
NCT01134575
PHASE2

CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

The goal of this clinical research study is to learn if CMC-544 given alone, and possibly given in combination with rituximab, can help to control the disease in patients with ALL. The safety of the study drug(s) will also be studied.

Official title: Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) With CMC-544 (Inotuzumab Ozogamycin), With or Without Later Addition of Rituximab

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2010-06-04

Completion Date

2018-04-18

Last Updated

2026-07-30

Healthy Volunteers

No

Interventions

DRUG

CMC-544 (Inotuzumab Ozogamycin)

First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. Part 2 CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.

DRUG

Rituximab

With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States