Phase 2
N=10
Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00440726 ↗Enrolled (actual)
10
Serious AEs
61.3%
Results posted
Feb 2020
Primary outcome: Primary: Occurrence of a Dose-Limiting Toxicity (Phase 1) — 0; 1; 4; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bortezomib (Drug); Dexamethasone (Drug); PEG-asparaginase (Drug); Doxorubicin (Drug); Cytarabine (Drug); Methotrexate (Drug); Vincristine (Drug); Triple IT Therapy (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of a Dose-Limiting Toxicity (Phase 1) |
0; 1; 4; 5 | — |
| PRIMARY Achievement of Complete Remission (CR) |
6; 14; 0; 0; 2; 0 | — |
Summary
This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.
Eligibility Criteria
Inclusion Criteria
The eligibility criteria listed below are interpreted literally and cannot be waived.
- Age Patients must be 1 year of age at study entry.
- Diagnosis Patients must have relapsed or refractory ALL with a M3 marrow (marrow blasts >25%). Patients with CNS I, II or III or testicular disease are eligible.
- Performance Level Karnofsky > 50% for patients > 10 years of age and Lansky > 50% for patients 2 x the upper limit of normal for age at the institution's laboratory.
- Liver/Pancreatic Function
- Direct bilirubin > 1.5x the institutional ULN for age. A total bilirubin result that is less than 1.5 times the institutional ULN for age may be used for eligibility if a direct bilirubin result is not available.
- SGPT (ALT) > 4 x institutional ULN
- Grade 3 or greater pancreatitis as defined by the CTCAE v3.0
- History of any L-asparaginase induced pancreatitis
- Amylase or Lipase > 2 x institutional ULN
- Cardiac Function Patients will be excluded if their shortening fraction by echocardiogram is less than 30%.
- Patients with Down Syndrome are excluded.
- Infection
- Patients will be excluded if they have an active uncontrolled infection.
- Patients will be excluded if they have had a positive culture within 2 weeks of study entry.
- Patients with grade 2 or greater motor or sensory neuropathy per CTC 3.0 criteria.
- Patients planning on receiving other investigational agents while on this study. (An investigational agent is defined as any drug not currently approved for use in humans.)
- Patients planning on receiving other anti-cancer therapies while on this study. Hydroxyurea for cyto-reduction is allowed prior to the start of therapy.
- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- Patients who have started protocol therapy prior to enrollment. Patient may still enroll if IT therapy was given within 72 hours of study enrollment as part of the diagnostic lumbar procedure.
Data sourced from ClinicalTrials.gov (NCT00440726). 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.