Clinical trial · Interventional
Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"
Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia
NCT04920968CI-TRIAL-00088860OVERALLrecruitingPhase 2ClinicalTrials.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)
A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).
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 |
|---|---|---|---|
| CD20-positive Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Obinutuzumab
- description
- Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.
- interventionNames
- Drug: Obinutuzumab
- type
- ACTIVE_COMPARATOR
- label
- Rituximab
- description
- Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years. 2. Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts. 3. Signed written informed consent. 4. Adequate contraception in case of women with child-bearing potential Exclusion Criteria: 1. Lymphoblastic lymphoma with bone marrow blasts\<20%. 2. Patients with a history of chronic myeloid leukemia or other myeloproliferative disease. 3. Major surgery within 4 weeks before enrollment. 4. Impaired cardiac function: ejection fraction \<40% on echocardiography, QTc interval \> 450 ms on baseline electrocardiogram. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias). 5. Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus 6. Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease. 7. Serum creatinine \> 2 times the upper normal limit of the laboratory, total bilirubin\> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase \> 5 upper normal limit, unless related to Acute lymphoblastic leukemia 8. Intolerance to treatment with monoclonal antibody. 9. Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age. 10. Inability to obtain written informed consent. 11. Inability to comply with regular monitoring.
References
Publications (0)
Data not yet available
No reference posted for this study.