Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT03515200
Phase
PHASE1
Status
Terminated

Conditions

  • Acute Lymphoblastic Leukemia With Failed Remission
  • Acute Lymphoblastic Leukemia, in Relapse

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Palbociclib Oral Capsule — DRUG
    Given orally or nasogastrically (NG).
  • Intrathecal Triple Therapy — DRUG
    Given intrathecally (IT).
  • Dexamethasone — DRUG
    Given orally, nasogastrically (NG) or intravenously (IV).
  • Bortezomib — DRUG
    Given intravenously (IV) or subcutaneously (SC).
  • Dasatinib — DRUG
    Given orally or nasogastrically (NG).
  • Doxorubicin — DRUG
    Given intravenously (IV).
  • Ruxolitinib — DRUG
    Given orally or nasogastrically (NG).

Study Details

Leukemia cells grow and divide fast and out of control. In normal cells, certain proteins called CDK4 and CDK6 control cell growth. The study drug called palbociclib works by blocking the CDK4 and CDK6 proteins. Palbociclib has been shown to kill leukemia cells in the laboratory and in animal studies. Palbociclib will be added to other chemotherapy drugs, such as dexamethasone, that are known to be effective in treating childhood ALL. This study will be done in two parts: Part 1: Dose Escalation and Part 2: Dose Expansion. The goal of Part 1 of the study is to find the highest tolerable combination of palbociclib and chemotherapy that the investigators can give to patients with leukemia. Once those doses are determined, the investigators will enroll patients on Part 2: Dose Expansion. This phase will enroll additional patients that receive the highest tolerated dose of palbociclib as determined in part 1, in order to better understand the side effects and how effective this treatment approach is. With this research study, the investigators hope to meet the following goals: * To find the highest tolerable dose of palbociclib in combination with chemotherapy that can be given without causing severe side effects; * To learn what kind of side effects palbociclib in combination with chemotherapy may have; and * To learn more about the biology effects of palbociclib on the cells in the participant's body. Up to 40 children, adolescents and young adults will participate in both parts of this study at St. Jude only.

Key Dates

Start date
Apr 20, 2018
Status verified
Aug 2020
Primary completion
Jul 29, 2020
Completion
Jul 29, 2020

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    This study will be done in two parts: Part 1: Dose escalation and Part 2: Dose expansion. In Part 1 - Dose escalation: Patients that lack Ph+ or Ph-like ALL, palbociclib, initially at 50mg/m2/day, 40% of the adult MTD, will be administered on Days 1-5 and 11-15, and escalated based on tolerability. If our highest dosing of 100mg/m2/day is tolerated, we will have a final dose level that receives an additional 10 days of palbociclib (Days 1-5, 11-15, and 21-30). For patients that are Ph+ or have Ph-like ALL that are also receiving dasatinib or ruxolitinib: palbociclib, initially at 75mg/m2/day, 60% of the adult MTD, will be administered on Days 1-5 and 11-15 and escalated based on tolerability. In Part 2 - Dose expansion: After determination of dose in Part 1, an additional 10 patients will be enrolled to confirm tolerability.

Primary Outcome Measure

Maximum tolerated dose (MTD) of palbociclib plus chemotherapy [ Time Frame: End of cycle 1 (day 40 of therapy) ]

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105-

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By research site
St. Jude Children's Research Hospital· Memphis, TN

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