Palbociclib and Dexamethasone in Treating Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03472573|
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent B Acute Lymphoblastic Leukemia Refractory B Acute Lymphoblastic Leukemia||Drug: Palbociclib Drug: Dexamethasone||Phase 1|
I. To determine the dose and schedule of the combination of palbociclib and dexamethasone in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia (ALL).
ii. To determine the safety and tolerability of the combination of palbociclib and dexamethasone in patients with relapsed or refractory adult B-cell ALL.
I. To evaluate the activity of palbociclib in combination with dexamethasone in patients with relapsed or refractory B-cell ALL.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Palbociclib in Combination With Dexamethasone in Relapsed or Refractory Adult B-Cell Acute Lymphoblastic Leukemia (ALL)|
|Actual Study Start Date :||May 9, 2018|
|Estimated Primary Completion Date :||November 15, 2019|
|Estimated Study Completion Date :||November 2020|
Experimental: Treatment (palbociclib, dexamethasone)
INDUCTION: Participants receive palbociclib PO daily and dexamethasone PO daily for 28 days in the absence of disease progression or unacceptable toxicity. Participants with disease response (M0, M1, or M2) continue to Maintenance. Patients without a disease response discontinue treatment.
MAINTENANCE: Participants receive dexamethasone with a taper PO daily on days 1-7. Participants also receive palbociclib daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Incidence of dose limiting toxicities (DLT) of the combination of palbociclib and dexamethasone [ Time Frame: Up to 28 days after discontinuation of palbociclib and dexamethasone ]Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 should be used for grading.
- Maximum tolerated dose (MTD) of the combination of palbociclib and dexamethasone defined as the highest dose level where a DLT occurs in at most one out of six patients treated [ Time Frame: Up to 28 days after discontinuation of palbociclib and dexamethasone ]CTCAE version 4.03 should be used for grading.
- Clinically relevant responses to therapy determined by bone marrow biopsy [ Time Frame: Up to 1 year ]Response rate defined as the proportion of patients who achieve an M, M1, or M2 response will be estimated along with a 95% confidence interval.
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): NCT03472573
|Contact: Margaret Kasner, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Margaret Kasner, MD 215-955-8874 email@example.com|
|Principal Investigator: Margaret Kasner, MD|
|Principal Investigator:||Margaret Kasner, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|