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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoblastic Leukemia, Lymphoma

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary purpose:

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Josep Mª Ribera, Doctor

Investigator Role:

Study Chair

Investigator Affiliation:

HOSPITAL GERMANS TRIAS I PUJOL

Authority:

Spain: Ministry of Health and Consumption

Study ID:

2004-004414-17

NCT ID:

NCT00388531

Start Date:

March 2006

Completion Date:

June 2011

Related Keywords:

  • Lymphoblastic Leukemia
  • Lymphoma
  • Acute Lymphoblastic Leucemia
  • Aggressive Non-Hodgkin-Lymphoma
  • CNS relapse
  • Cytarabine liposome
  • Aggression
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma

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