Acute Leukemia Clinical Trial
Official title:
A Phase 1 Study Of Palbociclib (IND#141416), A CDK 4/6 Inhibitor, In Combination With Chemotherapy In Children With Relapsed Acute Lymphoblastic Leukemia (ALL) Or Lymphoblastic Lymphoma (LL)
AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL). LL patients are included because the patient population is rare and these patients are most commonly treated with ALL regimens. The proposed palbociclib starting dose for this study will be 50 mg/m^2/day for 21 days.
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of palbociclib administered in combination with re-induction chemotherapy in pediatric patients with relapsed B- or T-lineage ALL/LL. II. To define and describe the toxicities of palbociclib administered on this schedule. III. To characterize the pharmacokinetics of palbociclib in pediatric patients with relapsed B- or T-lineage ALL/LL. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of palbociclib in combination with chemotherapy for children with relapsed ALL/LL within the confines of a Phase 1 study. II. To assess the biologic activity of palbociclib in this patient population. OUTLINE: Patients receive Palbociclib PO (or via NG-tube) once daily on Days 1-21; Intrathecal cytarabine (IT ARAC) on Day 1, Doxorubicin IV push or infusion over 1-15 min on Day 4; Prednisone or prednisolone PO on days 4-31; Vincristine IV push or mini-bag per institutional policy on Days 4, 11, 18, and 25; and Pegaspargase IV over 1-2 hours on Days 5, and 18. If CNS3 leukemia is present, patients receive Intrathecal Triple Therapy (ITT) on days 4, 11,18, and 25. If CNS1 or 2 disease status, patients receive Methotrexate (IT MTX) on Days 18 and 32. Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC. Treatment will be given for one cycle, 32 days, in the absence of disease progression or unacceptable toxicity. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05088356 -
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
|
Phase 1 | |
| Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
| Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05170828 -
Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
|
Phase 1 | |
| Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
| Active, not recruiting |
NCT01956630 -
Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT
|
Phase 1/Phase 2 | |
| Completed |
NCT00988013 -
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
|
N/A | |
| Enrolling by invitation |
NCT01728402 -
Pathogenesis of Hematologic Malignancies
|
||
| Active, not recruiting |
NCT03595800 -
Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen
|
Phase 3 | |
| Completed |
NCT02440178 -
Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia
|
Phase 2 | |
| Recruiting |
NCT05071482 -
Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL
|
Phase 4 | |
| Withdrawn |
NCT03138395 -
iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML
|
N/A | |
| Completed |
NCT03042676 -
Electronic Database for the Follow up of the ATG_FamilyStudy
|
||
| Completed |
NCT04597086 -
Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients
|
N/A | |
| Terminated |
NCT03588936 -
Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant
|
Phase 1 | |
| Recruiting |
NCT05521204 -
Olverembatinib for FGFR1-rearranged Neoplasms
|
Phase 2 | |
| Not yet recruiting |
NCT04084327 -
Immunophenotyping of Acute b Cell Lymphoblstic Leukemia
|
||
| Terminated |
NCT00852709 -
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias
|
Phase 1 | |
| Not yet recruiting |
NCT06026839 -
Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors
|