Phase 2
N=90
CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01134575 ↗Enrolled (actual)
90
Serious AEs
42.2%
Results posted
May 2019
Primary outcome: Primary: Number of Patients With Response — 3; 25; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CMC-544 (Inotuzumab Ozogamycin) (Drug); Rituximab (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Response |
3; 25; 24 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Previously treated ALL (including Burkitt's lymphoma and lymphoblastic lymphoma) in relapse or primary refractory. Patients in first relapse will be eligible regardless of the first remission duration. At least 10 patients in Salvage 1-2 will be treated to assess anti-ALL response more precisely.
- Age 16 years or older. Pediatric patients ( /= 1 year postmenopausal or surgically sterilized).
Exclusion Criteria
- Patient with active heart disease (NYHA class >/= 3 as assessed by history and physical examination).
- Patients with a cardiac ejection fraction (as measured by either Radionuclide angiography (MUGA) or echocardiogram) /= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (Concurrent therapy for central nervous system [CNS] prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the Principal Investigator.
- Prior allogeneic stem cell transplant in previous 4 months.
- Peripheral lymphoblasts > 50 x 10^9/L.
- Pregnant and breast-feeding patients are excluded.
- Patients with known hepatitis B are excluded.
Data sourced from ClinicalTrials.gov (NCT01134575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.