Clinical trial · Interventional
CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)
Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) With CMC-544 (Inotuzumab Ozogamycin), With or Without Later Addition of Rituximab
NCT01134575CI-TRIAL-00119970completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMC-544 (Inotuzumab Ozogamycin) | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2
- description
- First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) 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. 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.
- interventionNames
- Drug: CMC-544 (Inotuzumab Ozogamycin)
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Age 16 years or older. Pediatric patients (\<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each. 3. Zubrod performance status 0-3. 4. Adequate liver function (bilirubin \</= 1.5 mg/dL and Alanine transaminase (SGPT) or Aspartate transaminase (SGOT) \</= 3 x upper limit of normal \[ULN\], unless considered due to tumor), and renal function (creatinine \</= 2 mg/dL). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \</= 2.0 mg/dL and creatinine \</= 3 mg/dL. 5. Male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. Non-childbearing is defined as \>/= 1 year postmenopausal or surgically sterilized). Exclusion Criteria: 1. Patient with active heart disease (NYHA class \>/= 3 as assessed by history and physical examination). 2. Patients with a cardiac ejection fraction (as measured by either Radionuclide angiography (MUGA) or echocardiogram) \< 45% are excluded. 3. Patients who receive other chemotherapy. Patients must have been off previous therapy for \>/= 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. 4. Prior allogeneic stem cell transplant in previous 4 months. 5. Peripheral lymphoblasts \> 50 x 10\^9/L. 6. Pregnant and breast-feeding patients are excluded. 7. Patients with known hepatitis B are excluded.
References
Publications (2)
- DERIVEDZhao Y, Short NJ, Kantarjian HM, Chang TC, Ghate PS, Qu C, Macaron W, Jain N, Thakral B, Phillips AH, Khoury J, Garcia-Manero G, Zhang W, Fan Y, Yang H, Garris RS, Nasr LF, Kriwacki RW, Roberts KG, Konopleva M, Jabbour EJ, Mullighan CG. Genomic determinants of response and resistance to inotuzumab ozogamicin in B-cell ALL. Blood. 2024 Jul 4;144(1):61-73. doi: 10.1182/blood.2024023930. PMID 38551807
- DERIVEDKantarjian H, Thomas D, Jorgensen J, Jabbour E, Kebriaei P, Rytting M, York S, Ravandi F, Kwari M, Faderl S, Rios MB, Cortes J, Fayad L, Tarnai R, Wang SA, Champlin R, Advani A, O'Brien S. Inotuzumab ozogamicin, an anti-CD22-calecheamicin conjugate, for refractory and relapsed acute lymphocytic leukaemia: a phase 2 study. Lancet Oncol. 2012 Apr;13(4):403-11. doi: 10.1016/S1470-2045(11)70386-2. Epub 2012 Feb 21. PMID 22357140