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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388531
• Other study ID #: 2004-004414-17
• Secondary ID: DEPOCYLAN
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2006
• Last updated: September 16, 2011
• Start date: March 2006
• Est. completion date: June 2011

Study information

• Verified date: September 2011
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Leukemia
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Depocyte®
Depocyte® is a cytostatic drug

Locations

Country	Name	City	State
Spain	Hospital "Santa Creu i Sant Pau"	Barcelona
Spain	Hospital Clínico y Provincial de Barcelona	Barcelona
Spain	Hospital Germans Trias i Pujol	Barcelona
Spain	Hospital Clínico San Carlos de Madrid	Madrid
Spain	Hospital Doce de Octubre	Madrid
Spain	. Hospital Clínico Universitario Virgen de la Victoria	Málaga
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary purpose:		1 year	No
Primary	response rate after one application of DepoCyte®.		1 year	No
Secondary	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		6 months	No

External Links

•   CRO
•   Pethema Foundation web
•   Spanish association of Haematology