Clinical trial · Interventional
Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)
A Feasibility Pilot and Phase II Study Of Chemoimmunotherapy With Epratuzumab (IND #12034) for Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia (ALL)
NCT00098839CI-TRIAL-00030785completedPhase 1 / Phase 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)
This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively.
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 |
|---|---|---|---|
| Recurrent Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexrazoxane hydrochloride | Drug | — | UNRESOLVED |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| epratuzumab | Biological | — | UNRESOLVED |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| L-asparaginase | Drug | Asparaginase | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Reinduction Chemoimmunotherapy with Epratuzumab once weekly
- description
- Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.
- interventionNames
- Drug: L-asparaginase
- Drug: doxorubicin hydrochloride
- Drug: therapeutic hydrocortisone
- Drug: vincristine sulfate
- Biological: epratuzumab
- Drug: cytarabine
- Drug: prednisone
- Drug: pegaspargase
- Drug: dexrazoxane hydrochloride
- Drug: methotrexate
- Drug: etoposide
- Drug: cyclophosphamide
- Drug: leucovorin calcium
- Biological: filgrastim
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 31 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosis of B lymphoblastic leukemia (B-ALL)
* At least 25% expression of CD22 by immunophenotyping
* In marrow relapse (M3 bone marrow) with or without associated extramedullary disease as defined by 1 of the following:
* In first or later marrow relapse occurring any time after initial diagnosis (part A \[closed to accrual as of 10/30/06\] or B)
* In first, early marrow relapse with or without associated extramedullary disease occurring \< 36 months from the time of initial diagnosis (part B only)
* No B-cell L3 morphology OR evidence of a regulator gene that codes for a transcription factor (MYC) translocation by molecular or cytogenetic analysis
* No Down syndrome
* Patients with CNS or other extramedullary site involvement are allowed
* Performance status - Karnofsky 50-100% (for patients \> 10 years of age)
* Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
* White Blood Count (WBC) ≤ 50,000/mm\^3 (part A only \[closed to accrual as of 10/30/06\])
* Bilirubin ≤ 1.5 times upper limit of normal unless disease-related (ULN)
* Alanine aminotransferase (ALT) ≤ 5 times ULN
* Albumin ≥ 2 g/dL
* Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
* Creatinine as defined by age as follows:
* ≤ 0.5 mg/dL (for patients \< 1 year old)
* ≤ 0.8 mg/dL (for patients 1 to 5 years old)
* ≤ 1.0 mg/dL (for patients 6 to 10 years old)
* ≤ 1.2 mg/dL (for patients 11 to 15 years old)
* ≤ 1.5 mg/dL (for patients \> 15 years old)
* Shortening fraction ≥ 27% by echocardiogram
* Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA)
* No dyspnea at rest
* No exercise intolerance
* Pulse oximetry \> 94%
* No active or uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Recovered from prior immunotherapy
* At least 4 months since prior stem cell transplantation or rescue AND no evidence of active graft-vs-host disease
* At least 7 days since prior hematopoietic growth factors
* At least 7 days since prior biologic therapy\*
* No other concurrent immunotherapy
* No other concurrent biologic therapy
* Recovered from prior chemotherapy
* No waiting period for children who relapse while receiving standard ALL maintenance therapy
* No prior cumulative anthracycline exposure \> 400 mg/m\^2\*
* No concurrent chemotherapy
* Recovered from prior radiotherapy
* No concurrent radiotherapy
* At least 2 days since prior hydroxyurea
* No other concurrent investigational drugs
* No other concurrent anticancer agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.