Status:
COMPLETED
Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Novartis
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-21 years
Phase:
PHASE1
Brief Summary
Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus is approved for...
Detailed Description
Study Treatment: The study treatment lasts 32 days during which time you will be taking the study drug Everolimus daily for 32 days in addition to standard chemotherapy drugs. Below lists the study dr...
Eligibility Criteria
Inclusion
- ALL in first bone marrow relapse occuring \> 18 months from initial diagnosis
- Normal organ function
- Maximum prior cumulative doxorubicin dose of \</= 360 mg/m2 or equivalent
Exclusion
- Prior therapy for ALL except for intrathecal (IT) chemotherapy
- Pregnant or lactating
- Individuals whose relapsed ALL harbors a t(9;22)/BCR-ABL fusion
- Individuals whose lymphoblasts have surface immunoglobulin by flow cytometry and/or t(8;14), t(2;8), or t(8;22)
- Down syndrome
- Prior stem cell transplant
- History of asparaginase-associated pancreatitis
- Active lung disease
- Impairment of gastrointestinal function or gastrointestinal disease
- Severe and/or uncontrolled intercurrent illness
- Documented history of previous or current Hepatitis B or C infection
- History of a different malignancy (other than ALL) unless disease-free for at 5 years and deemed by the investigators to be at low risk for recurrence of that malignancy
- HIV positive on combination antiretroviral therapy
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01523977
Start Date
November 1 2011
End Date
November 1 2018
Last Update
July 18 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSF
San Francisco, California, United States, 94143
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
4
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611