Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma
Information source: PETHEMA Foundation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoblastic Leukemia; Lymphoma
Intervention: Depocyte® (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: PETHEMA Foundation Official(s) and/or principal investigator(s): Josep Mª Ribera, Doctor, Study Chair, Affiliation: Germans Trias i Pujol Hospital
Summary
The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.
Clinical Details
Official title: Multicenter, Prospective, Open Label Trial, Uncontrolled to Determine the Efficacy and Safety of Depocyt ® for the Treatment of CNS Relapse in Adult Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary purpose:response rate after one application of DepoCyte®.
Secondary outcome: Death in induction and in CR, Time to neurological progression, The frequency of improvement in pre-existing meningeal-disease related neurological symptoms,Karnofsky Performance Status,Survival,Toxicity according to CTCAE v.3
Detailed description:
It is a clinical study multicenter, prospective, open label trial, uncontrolled and
nonrandomized
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Hospital "Santa Creu i Sant Pau", Barcelona, Spain
Hospital ClÃnico y Provincial de Barcelona, Barcelona, Spain
Hospital Germans Trias i Pujol, Barcelona, Spain
Hospital ClÃnico San Carlos de Madrid, Madrid, Spain
Hospital Doce de Octubre, Madrid, Spain
. Hospital ClÃnico Universitario Virgen de la Victoria, Málaga, Spain
Hospital ClÃnico Universitario de Salamanca, Salamanca, Spain
Hospital Universitario Virgen del RocÃo, Sevilla, Spain
Hospital La Fe, Valencia, Spain
Additional Information
Spanish association of Haematology CRO
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Starting date: March 2006
Last updated: September 16, 2011
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