Status:
COMPLETED
Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma
Lead Sponsor:
PETHEMA Foundation
Conditions:
Lymphoblastic Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.
Detailed Description
It is a clinical study multicenter, prospective, open label trial, uncontrolled and nonrandomized
Eligibility Criteria
Inclusion
- Patients with acute lymphoblastic leukemia or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse.
- CNS involvement must be demonstrated by:
- A positive ventricular or lumbar CSF cytology defined as CSF cell counts \> 5/µl (19/3 cells), obtained within 10 days prior to inclusion OR
- Characteristic signs and symptoms of neoplastic meningitis PLUS an MRI or CT scan indicating the presence of meningeal involvement. Patients with combined relapse in CNS and other locations may be included in case that systemic therapy with CNS active drugs (HDMTX;HDAC, Thiotepa) can be postponed for at least 2 weeks.
- Karnofsky \>60%
- Age \>18 years old
- Recovery from grade III/IV toxicities attributable to prior treatment with the exception of hematotoxicity.
- No severe heart, lung, liver or kidney dysfunction.
- The patient or guardian must be competent to provide informed consent and must provide written informed consent prior to the initiation of study procedures
Exclusion
- Failure (as defined by no clearance of the CSF) to \> 1 dose of prior intrathecal MTX or cytarabine or triple (MTX, ARAC, dexamethasone) therapy
- History of previous severe neurotoxicity (grade III-IV) attributed to intrathecal therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine induced peripheral neuropathy is accepted)
- Prior CNS relapse \< 1 month before
- uncontrolled infection
- The patient must not be pregnant or breast feeding. If the patient is a female of child-bearing potential she must have a negative (urine or serum) pregnancy test and be using effective methods to prevent pregnancy
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00388531
Start Date
March 1 2006
End Date
June 1 2011
Last Update
September 19 2011
Active Locations (9)
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1
Hospital "Santa Creu i Sant Pau"
Barcelona, Barcelona, Spain
2
Hospital Clínico y Provincial de Barcelona
Barcelona, Barcelona, Spain
3
Hospital Germans Trias i Pujol
Barcelona, Barcelona, Spain
4
Hospital Clínico San Carlos de Madrid
Madrid, Madrid, Spain