Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412243
Status:
COMPLETED
Last Update Posted:
2013-03-12
First Post:
2006-12-14
Brief Title:
Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of Clofarabine Plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia ALL
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of the drugs clofarabine and cyclophosphamide that can be given together in the treatment of relapsed or refractory ALL The safety of the combination treatment will also be studied
Objectives
Phase I
1 To establish toxicities and safety of the proposed combination
2 To establish the dose-limiting toxicity DLT and maximum tolerated dose MTD of the combination to proceed with the phase II part of the study
Phase II
3 To establish the efficacy complete and overall response of the proposed combination
4 To analyze pharmacokinetic PK and pharmacodynamic PD properties of clofarabine as well as the impact on DNA repair of leukemic blasts with the proposed combination
Objectives
Phase I
1 To establish toxicities and safety of the proposed combination
2 To establish the dose-limiting toxicity DLT and maximum tolerated dose MTD of the combination to proceed with the phase II part of the study
Phase II
3 To establish the efficacy complete and overall response of the proposed combination
4 To analyze pharmacokinetic PK and pharmacodynamic PD properties of clofarabine as well as the impact on DNA repair of leukemic blasts with the proposed combination
Detailed Description:
Clofarabine is a drug that is designed to interfere and disrupt important metabolic pathways of cancer cells by interfering with their multiplication and slowing or stopping their growth Cyclophosphamide is also designed to destroy cancer cells by interfering with their multiplication and slowing or stopping their growth and spread throughout the body Cyclophosphamide is commonly used in the treatment of ALL
If you are found to be eligible to take part in this study you will receive clofarabine by vein over about 60 minutes once a day for 3 to 5 days Cyclophosphamide will be given by vein over about 3 hours twice a day for 3 to 5 days These 3-5 days are considered 1 cycle of therapy
As the safety of this combination has not been established yet at least the first 2 participants on this study will receive clofarabine for 3 days and cyclophosphamide at a lower dose than usually given for 3 days 6 doses Should there be no serious side effects that can be related to the study drugs the next group of 2 participants will receive clofarabine over 3 days and a slightly higher dose of cyclophosphamide for 3 days 6 doses Should there still be no serious side effects at that level 2 further levels will be tested where both clofarabine and cyclophosphamide are then given over 4 days and eventually 5 days Should serious and study drug-related side effects occur at any point during this increase of doses a certain dose level along this increase will be defined as the appropriate dose for all future participants to receive It is estimated that about 30 participants will receive therapy during the dose escalations portion of this study Phase I It is estimated that about 25 more participants will receive therapy at the dose levels that are considered best Phase II
During treatment you will have a physical exam at least once a week You may also be asked about the level of your daily activities how you are feeling and which medications you are taking currently Routine blood samples about 1 tablespoon each will be drawn at least 1-3 times weekly and more frequently if considered necessary A bone marrow aspirate andor biopsy will be repeated starting at about Day 14 and will be repeated every 1 to 2 weeks until the study doctors can decide for sure whether you have responded or not In some cases a repeat bone marrow test may not be necessary but this decision will be made by your treating doctor
If you respond well after your first round of therapy you may receive up to 6 additional courses of therapy Each course will be repeated about every 3 to 7 weeks at a slightly lower dose of both drugs than was used during the first round of therapy Later doses can also be changed depending on what type of side effects you may experienced with earlier rounds of therapy
At the end of the study a heart scan either an Echo or MUGA scan will be repeated About 1 tablespoon of blood will be taken for routine blood tests A focused physical exam may also be repeated
This is an investigational study All drugs in this study are FDA approved and commercially available Their use together in this study is investigational About 55 patients will take part in this study All will be enrolled at M D Anderson
If you are found to be eligible to take part in this study you will receive clofarabine by vein over about 60 minutes once a day for 3 to 5 days Cyclophosphamide will be given by vein over about 3 hours twice a day for 3 to 5 days These 3-5 days are considered 1 cycle of therapy
As the safety of this combination has not been established yet at least the first 2 participants on this study will receive clofarabine for 3 days and cyclophosphamide at a lower dose than usually given for 3 days 6 doses Should there be no serious side effects that can be related to the study drugs the next group of 2 participants will receive clofarabine over 3 days and a slightly higher dose of cyclophosphamide for 3 days 6 doses Should there still be no serious side effects at that level 2 further levels will be tested where both clofarabine and cyclophosphamide are then given over 4 days and eventually 5 days Should serious and study drug-related side effects occur at any point during this increase of doses a certain dose level along this increase will be defined as the appropriate dose for all future participants to receive It is estimated that about 30 participants will receive therapy during the dose escalations portion of this study Phase I It is estimated that about 25 more participants will receive therapy at the dose levels that are considered best Phase II
During treatment you will have a physical exam at least once a week You may also be asked about the level of your daily activities how you are feeling and which medications you are taking currently Routine blood samples about 1 tablespoon each will be drawn at least 1-3 times weekly and more frequently if considered necessary A bone marrow aspirate andor biopsy will be repeated starting at about Day 14 and will be repeated every 1 to 2 weeks until the study doctors can decide for sure whether you have responded or not In some cases a repeat bone marrow test may not be necessary but this decision will be made by your treating doctor
If you respond well after your first round of therapy you may receive up to 6 additional courses of therapy Each course will be repeated about every 3 to 7 weeks at a slightly lower dose of both drugs than was used during the first round of therapy Later doses can also be changed depending on what type of side effects you may experienced with earlier rounds of therapy
At the end of the study a heart scan either an Echo or MUGA scan will be repeated About 1 tablespoon of blood will be taken for routine blood tests A focused physical exam may also be repeated
This is an investigational study All drugs in this study are FDA approved and commercially available Their use together in this study is investigational About 55 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None