Dasatinib Combination for Chronic Lymphocytic Leukemia(CLL) With Refractory Disease (D'ACCORD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01051115|
Recruitment Status : Unknown
Verified August 2011 by A.P. Kater, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was: Recruiting
First Posted : January 18, 2010
Last Update Posted : August 31, 2011
Patients with chemo refractory CLL have a poor prognosis. 2 independent mechanisms are attributed to the development of chemoresistance in CLL. The first is a shift in the balance between pro- and anti-apoptotic regulators. The second mechanism is based on acquired mutations resulting in a dysfunctional p53 response. Recent studies indicate that the tyrosine kinase inhibitor dasatinib acts synergistically with both purine analogies and alkylating agents. Also, dasatinib has the potency to restore the apoptotic balance of CLL cells.
Hypothesis: Dasatinib will be clinically active in chemo-refractory CLL patients and will act synergistically with the purine-analogue fludarabine.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Dasatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dasatinib Combination for Chronic Lymphocytic Leukemia Patients With Chemo Refractory Disease|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||January 2016|
Patients will be treated with dasatinib monotherapy 100mg daily. At four weeks patients will be re-evaluated. Patients with less than a partial response will receive fludarabine (orally 40mg/daily for 3 days q28) in addition to dasatinib.
Chemo-refractory CLL patients will be treated with dasatinib monotherapy 100mg daily.Patients with less than a partial response at 4 weeks will receive fludarabine (orally 40mg/daily for 3 days q28) in addition to dasatinib for a maximum of 6 cycles. Patients with at least a partial response will continue dasatinib monotherapy. Patients that receive monotherapy after the initial 28 days and that develop progressive disease will 'cross-over' to the combination treatment.
- response rate and response quality [ Time Frame: At 32 weeks of either dasatinib monotherapy or after 6 cycles of fludarabine and dasatinib combination ]
- overall safety profile of these treatment approaches, event free survival, progression free survival, relapse or death, disease free survival [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051115
|Contact: Arnon P Kater, MD, PhDfirstname.lastname@example.org|
|Contact: Marjolein Spiering, Msemail@example.com|
|Maastricht university medical center||Not yet recruiting|
|Maastricht, Limburg, Netherlands, 6229 HX|
|Contact: Michel van Gelder, MD, PhD +31-43 - 387 6543 firstname.lastname@example.org|
|Academic Medical Center||Recruiting|
|Amsterdam, NH, Netherlands, 1105 AZ|
|Contact: Marjolein Spiering, Ms +31-20-5669111 email@example.com|
|Contact: Arnon P Kater, MD, PhD +31-20-5669111 firstname.lastname@example.org|
|Erasmus MC-Daniel den Hoed Cancer Center||Recruiting|
|Rotterdam, ZH, Netherlands, 3015 CE|
|Contact: Jeanette K Doorduijn, MD, PhD +31-10 7040704 email@example.com|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9713 GZ|
|Contact: Simon MG Daenen, MD, PhD +31-50 3616161 firstname.lastname@example.org|
|Principal Investigator:||Arnon P kater, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Principal Investigator:||Marinus HJ van Oers, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|