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Lymphoblastic LeukemiaPhase 2NCT00388531

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

A Phase 2 study testing Depocyte® in people with Lymphoblastic Leukemia and Lymphoma, run by PETHEMA Foundation at 9 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoblastic Leukemia, Lymphoma
What is being tested?
Depocyte®
How many people
10 participants
Where
9 sitesSpain
Study dates
Mar 2006to Jun 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Hospital "Santa Creu i Sant Pau"

    Barcelona, Barcelona

  • Hospital Clínico y Provincial de Barcelona

    Barcelona, Barcelona

  • Hospital Germans Trias i Pujol

    Barcelona, Barcelona

  • Hospital Clínico San Carlos de Madrid

    Madrid, Madrid

  • Hospital Doce de Octubre

    Madrid, Madrid

  • . Hospital Clínico Universitario Virgen de la Victoria

    Málaga, Málaga

  • Hospital Clínico Universitario de Salamanca

    Salamanca

  • Hospital Universitario Virgen del Rocío

    Seville, Sevilla

  • Hospital La Fe

    Valencia, Valencia

Other trials in Spain

About this study

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

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

Read the detailed description

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

Being tested
Depocyte®
Keywords
Acute Lymphoblastic Leucemia, Aggressive Non-Hodgkin-Lymphoma, CNS relapse, Cytarabine liposome
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Depocyte®Drug

    Depocyte® is a cytostatic drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary purpose:

    Measured: 1 year

  2. response rate after one application of DepoCyte®.

    Measured: 1 year

Secondary outcomes (1)

  1. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionMar 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388531
Sponsor's protocol ID
2004-004414-17
Other IDs
DEPOCYLAN, 2004
Status last verified
Sep 2011
First submitted
16 Oct 2006
Last updated
19 Sep 2011
Results posted
No

Publications

  • Mastrangelo R, Poplack D, Bleyer A, Riccardi R, Sather H, D'Angio G. Report and recommendations of the Rome workshop concerning poor-prognosis acute lymphoblastic leukemia in children: biologic bases for staging, stratification, and treatment. Med Pediatr Oncol. 1986;14(3):191-4. doi: 10.1002/mpo.2950140317. No abstract available.

    PubMed 3528788

  • Gokbuget N, Hoelzer D. Meningeosis leukaemica in adult acute lymphoblastic leukaemia. J Neurooncol. 1998 Jun-Jul;38(2-3):167-80. doi: 10.1023/a:1005963732481.

    PubMed 9696368

  • Neale GA, Pui CH, Mahmoud HH, Mirro J Jr, Crist WM, Rivera GK, Goorha RM. Molecular evidence for minimal residual bone marrow disease in children with 'isolated' extra-medullary relapse of T-cell acute lymphoblastic leukemia. Leukemia. 1994 May;8(5):768-75.

    PubMed 8182934

  • Ribeiro RC, Rivera GK, Hudson M, Mulhern RK, Hancock ML, Kun L, Mahmoud H, Sandlund JT, Crist WM, Pui CH. An intensive re-treatment protocol for children with an isolated CNS relapse of acute lymphoblastic leukemia. J Clin Oncol. 1995 Feb;13(2):333-8. doi: 10.1200/JCO.1995.13.2.333.

    PubMed 7844594

  • Larson RA, Dodge RK, Burns CP, Lee EJ, Stone RM, Schulman P, Duggan D, Davey FR, Sobol RE, Frankel SR, et al. A five-drug remission induction regimen with intensive consolidation for adults with acute lymphoblastic leukemia: cancer and leukemia group B study 8811. Blood. 1995 Apr 15;85(8):2025-37.

    PubMed 7718875

  • Mandelli F, Annino L, Rotoli B. The GIMEMA ALL 0183 trial: analysis of 10-year follow-up. GIMEMA Cooperative Group, Italy. Br J Haematol. 1996 Mar;92(3):665-72. doi: 10.1046/j.1365-2141.1996.00394.x.

    PubMed 8616033

  • Morra E, Lazzarino M, Brusamolino E, Pagnucco G, Castagnola C, Bernasconi P, Orlandi E, Corso A, Santagostino A, Bernasconi C. The role of systemic high-dose cytarabine in the treatment of central nervous system leukemia. Clinical results in 46 patients. Cancer. 1993 Jul 15;72(2):439-45. doi: 10.1002/1097-0142(19930715)72:23.0.co;2-4.

    PubMed 8319175

  • Ellison RR, Mick R, Cuttner J, Schiffer CA, Silver RT, Henderson ES, Woliver T, Royston I, Davey FR, Glicksman AS, et al. The effects of postinduction intensification treatment with cytarabine and daunorubicin in adult acute lymphocytic leukemia: a prospective randomized clinical trial by Cancer and Leukemia Group B. J Clin Oncol. 1991 Nov;9(11):2002-15. doi: 10.1200/JCO.1991.9.11.2002.

    PubMed 1941059

  • Durrant IJ, Richards SM. Results of Medical Research Council trial UKALL IX in acute lymphoblastic leukaemia in adults: report from the Medical Research Council Working Party on Adult Leukaemia. Br J Haematol. 1993 Sep;85(1):84-92. doi: 10.1111/j.1365-2141.1993.tb08649.x.

    PubMed 8251413

  • Elonen E, Almqvist A, Hänninen A et al. Intensive treatment of acute lymphatic leukaemia in adults: ALL86 protocol. Haematologica. 1991;76 (Suppl 4):133

  • Gökbuget N, Aguion-Freire E, Diedrich H et al. Characteristics and outcome of CNS relapse in patients with acute lymphoblastic leukemia (ALL) [abstract]. Blood. 1999;94:1287a.

  • Gökbuget N, Arnold R, Eggeling B et al. Prospective evaluation of neurotoxicity of prophylactic intrathecal therapy in adult acute lymphoblastic leukemia. The Hematology Journal. 2000;1:591a.

  • Chessells JM. Central nervous system directed therapy in acute lymphoblastic leukaemia. Baillieres Clin Haematol. 1994 Jun;7(2):349-63. doi: 10.1016/s0950-3536(05)80207-0.

    PubMed 7803906

  • Gagliano RG, Costanzi JJ. Paraplegia following intrathecal methotrexate: report of a case and review of the literature. Cancer. 1976 Apr;37(4):1663-8. doi: 10.1002/1097-0142(197604)37:43.0.co;2-7.

    PubMed 946593

  • Dunton SF, Nitschke R, Spruce WE, Bodensteiner J, Krous HF. Progressive ascending paralysis following administration of intrathecal and intravenous cytosine arabinoside. A Pediatric Oncology Group study. Cancer. 1986 Mar 15;57(6):1083-8. doi: 10.1002/1097-0142(19860315)57:63.0.co;2-b.

    PubMed 3455842

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Depocyte® in people with Lymphoblastic Leukemia and Lymphoma, run by PETHEMA Foundation at 9 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary purpose: (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00388531, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2011.

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