Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00388531
First received: October 16, 2006
Last updated: September 16, 2011
Last verified: September 2011

October 16, 2006
September 16, 2011
March 2006
March 2011   (final data collection date for primary outcome measure)
  • The primary purpose: [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • response rate after one application of DepoCyte®. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The primary purpose:
  • response rate after one application of DepoCyte®.
Complete list of historical versions of study NCT00388531 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma
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

The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.

It is a clinical study multicenter, prospective, open label trial, uncontrolled and nonrandomized

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoblastic Leukemia
  • Lymphoma
Drug: Depocyte®
Depocyte® is a cytostatic drug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00388531
2004-004414-17, DEPOCYLAN
Not Provided
Pethema, pethema
PETHEMA Foundation
Not Provided
Study Chair: Josep Mª Ribera, Doctor HOSPITAL GERMANS TRIAS I PUJOL
PETHEMA Foundation
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP