Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

Part of paid clinical trials in Westwood, Kansas.

Sponsor
Leland Metheny
Study ID
NCT03104491
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acute Lymphocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Inotuzumab Ozogamicin — DRUG
    Inotuzumab ozogamicin, IV, 28 day cycles Phase 1 dosages: Dose Level -2 (0.1 mg/m\^2) Dose Level -1 (0.2 mg/m\^2) Dose Level 0 (0.3 mg/m\^2) Dose Level 1 (0.4 mg/m\^2) Dose Level 2 (0.5 mg/m\^2) Dose Level 3 (0.6 mg/m\^2)

Study Details

This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects. The Phase II portion of this study is to see what side effects are seen with medication after transplant. Inotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed/refractory acute lymphocytic leukemia (ALL). Inotuzumab ozogamicin is considered experimental in this study.

Key Dates

Start date
Jul 31, 2017
Status verified
Jun 2025
Primary completion
Nov 30, 2025
Completion
May 31, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Inotuzumab Ozogamicin
    Phase I: A maximum of 4 cycles will be allowed and doses will be adjusted in 0.1mg/m2 increments using a dose escalation scale depending on tolerability. Total range of dose levels for participants is 0.1-0.6mg/m\^2. Phase II: Participants will be enrolled until all Phase I participants have been followed and assessed for toxicity for at least 4 weeks after the fourth treatment dose of inotuzumab ozogamicin or 4 weeks after the participant goes off treatment, whichever comes first. Doses to be administered will be determined in the phase I portion of the study. The recommended phase 2 dose is 0.3mg/m2. Repeat cycles every 28 days for up to 4 cycles

Primary Outcome Measure

Phase I MTD [ Time Frame: Up to 112 days (16 weeks) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
The University of Kansas Cancer CenterWestwoodKansas66205
Nausheen Ahmed, MD
[email protected]
Dana-Farber Cancer InstituteBostonMassachusetts02215
Roman Shapiro, MD
[email protected]
University of Nebraska Medical CenterOmahaNebraska68106
Vijaya Bhatt, MD
[email protected]
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterClevelandOhio44195-
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106-5065
Leland Metheny, MD
[email protected]
800-641-2422
Leland Metheny (PRINCIPAL_INVESTIGATOR)
The James Cancer Hospital and Solove Research InstituteColumbusOhio43210
Sumithira Vasu, MBBS
[email protected]

Find similar trials in Westwood, KS

By research site
The University of Kansas Cancer Center· Westwood, KSDana-Farber Cancer Institute· Boston, MAUniversity of Nebraska Medical Center· Omaha, NEMemorial Sloan Kettering Cancer Center· New York, NYCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center· Cleveland, OHUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

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