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Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)

Primary Purpose

Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Imatinib Mesylate

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnose: suspected CML (hematology and/or myelogram and/or immunophenotyping and/or Leukocyte alkaline phosphatase [LAP]) to be confirmed, after, by cytogenetic and/or molecular biology. OBS: only CML Ph+ newly-diagnose in chronic or accelerate phase; resistant CML Ph+ to Interferon α (INF-α), Hydroxyurea and/or low-dose ARA-C in chronic or accelerate phase; CML Ph+ with cytogenetic relapse after BMT, that didn't use Imatinib previously, in chronic or accelerate phase.
Female patients of childbearing age, should have pregnancy test (blood βhCG) performed before treatment initiation. Effective contraception must be used. Pregnant women won't be included.
Karnofsky and Lansky scale: ≥40.
Life expectation > 8 weeks.
Laboratory: renal function (serum creatinine ≤ 1,5 x ULN and/or Clearance ≥70 ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x ULN, TGP < 3 x ULN and albumin > 2 g/dl.
CNS toxicity ≤ II
Cardiac function: normal ejection fraction.
Signed ICF by child legal responsible.

Exclusion Criteria:

Patient receiving any other tyrosine kinase inhibitor (TKI).
Pregnant patient or breastfeeding.
Patient considered incapable to follow purposed treatment.
Patients with molecular relapsed.
Medications:
- Colony stimulating: it cannot be administered at least 1 week before treatment.
- Anticonvulsants: Imatinib is metabolized by P-450 enzyme, thereby subject cannot receive drug that activates the P-450 system. The anticonvulsants allowed are valproic acid and benzodiazepines.
- Anticoagulants: The use of warfarin (Marevan) is not allowed. If anticoagulant is needed, low-molecular-weight heparin (LMWH) can be used. Avoid anticoagulants with platelets < 50000.
- INF-Α 48h before D1.
- Hydroxyurea 24h before D1.
- ARA-C doses >100 mg/m2 for 5-7 days, 14 days before D1.
- Anthracyclines, Mitoxantrone or Etoposide 21 days before D1.
- Any other chemotherapeutic agent 28 days before D1.
- Hematopoietic Cell Transplantation (HCT) 6 weeks before D1.

Sites / Locations

Hospital Santa Marcelina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imatinib Mesylate

Arm Description

Outcomes

Primary Outcome Measures

Evaluate the complete cytogenetic response with continuous-use of Imatinib.

Secondary Outcome Measures

Evaluate the response to continuous-use of Imatinib and the toxicity and tolerability in children with CML Ph+.

Full Information

NCT ID

NCT01221376

First Posted

October 14, 2010

Last Updated

March 25, 2013

Sponsor

Renato Melaragno

1. Study Identification

Unique Protocol Identification Number

NCT01221376

Brief Title

Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)

Official Title

Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2011 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Renato Melaragno

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Imatinib Mesylate

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Imatinib Mesylate

Other Intervention Name(s)

Glivec, MI

Intervention Description

Patient will receive Imatinib Mesylate, continuous-use, 260 mg/m2/day dose, maximum allowed 400 mg, for 24 months.

Primary Outcome Measure Information:

Title

Evaluate the complete cytogenetic response with continuous-use of Imatinib.

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Evaluate the response to continuous-use of Imatinib and the toxicity and tolerability in children with CML Ph+.

Time Frame

Up to 24 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnose: suspected CML (hematology and/or myelogram and/or immunophenotyping and/or Leukocyte alkaline phosphatase [LAP]) to be confirmed, after, by cytogenetic and/or molecular biology. OBS: only CML Ph+ newly-diagnose in chronic or accelerate phase; resistant CML Ph+ to Interferon α (INF-α), Hydroxyurea and/or low-dose ARA-C in chronic or accelerate phase; CML Ph+ with cytogenetic relapse after BMT, that didn't use Imatinib previously, in chronic or accelerate phase. Female patients of childbearing age, should have pregnancy test (blood βhCG) performed before treatment initiation. Effective contraception must be used. Pregnant women won't be included. Karnofsky and Lansky scale: ≥40. Life expectation > 8 weeks. Laboratory: renal function (serum creatinine ≤ 1,5 x ULN and/or Clearance ≥70 ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x ULN, TGP < 3 x ULN and albumin > 2 g/dl. CNS toxicity ≤ II Cardiac function: normal ejection fraction. Signed ICF by child legal responsible. Exclusion Criteria: Patient receiving any other tyrosine kinase inhibitor (TKI). Pregnant patient or breastfeeding. Patient considered incapable to follow purposed treatment. Patients with molecular relapsed. Medications: Colony stimulating: it cannot be administered at least 1 week before treatment. Anticonvulsants: Imatinib is metabolized by P-450 enzyme, thereby subject cannot receive drug that activates the P-450 system. The anticonvulsants allowed are valproic acid and benzodiazepines. Anticoagulants: The use of warfarin (Marevan) is not allowed. If anticoagulant is needed, low-molecular-weight heparin (LMWH) can be used. Avoid anticoagulants with platelets < 50000. INF-Α 48h before D1. Hydroxyurea 24h before D1. ARA-C doses >100 mg/m2 for 5-7 days, 14 days before D1. Anthracyclines, Mitoxantrone or Etoposide 21 days before D1. Any other chemotherapeutic agent 28 days before D1. Hematopoietic Cell Transplantation (HCT) 6 weeks before D1.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alejandro M Arancibia, MD

Organizational Affiliation

Casa de Saúde santa Marcelina

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital Santa Marcelina

City

Sao Paulo

State/Province

ZIP/Postal Code

08270-070

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)

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