Clove In The Treatment Of Relapsed Or Resistant Acute Leu... | NCT01385891

Studies
Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children

NCT01385891

Sponsor

Istituto Giannina Gaslini

Status

Completed

Last Update Posted

Jul 8, 2011Estimated

Enrollment

40Actual

Phase

Phase 2Phase 3

Conditions

Acute Leukemia

Interventions

Clofarabine VP 16 ciclophospahamide

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-004487-39	EudraCT Number

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jun 21, 2011

First Submission Date that Met QC Criteria

Jun 29, 2011

First Posted Date

Jun 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2011

Last Update Posted Date

Jul 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric.

Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
children with advanced leukemia	Experimental		Drug: Clofarabine VP 16 ciclophospahamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clofarabine VP 16 ciclophospahamide	Drug	Clofarabine intravenously 2-hour infusion,dose 40 mg/m2, followed by Etoposide (VP 16)100 mg/m2 i.v. over 2 hours and Cyclophosphamide 440 mg/m2 i.v. over 1 hour

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
response to treatment		after an expected average of 3 weeks after the first dose of each chemotherapy course

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with toxicity as a measure of safety and tolerability	Grade of toxicity defined according to the National Cancer's Inst. Common terminology Criteria (NCI CTCAE v3.0)	at an expected average of 4 weeks after the first dose of each chemotherapy course

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

presence of > 25% of blast in bone marrow
treatment with second line therapies
patients with resistant disease i.e. with >25% of blasts 21 days after the last cytostatic agent administration
children with persistent high MRD level (> 10-3) after first or further line chemotherapy, were considered eligible to the treatment
Relapsed after > months after SCT
Karnofsky score >50
a Forced Espiratory Volume >30%
sufficient hepatic and renal function defined as creatinine levels <2 × ULN, bilirubin <1.5 × ULN
aspartate and alanine aminotransferases <10 × ULN.

Exclusion Criteria:

isolated extra-medullary relapse, and active infections

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Concetta Micalizzi, MD	G. Gaslini Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
G.Gaslini Children's Hospital		Genova		16147	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D000077866	Clofarabine
D005047	Etoposide
D003520	Cyclophosphamide

Ancestor Terms

ID	Term
D000227	Adenine Nucleotides
D011685	Purine Nucleotides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring

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