ABT-751 With Chemotherapy for Relapsed Pediatric ALL

Status Terminated

Clinical Trial Summary

This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.

Clinical Trial Description

All patients will receive the 2 courses of chemotherapy unless medical complications prevent the administration of some of the drugs. Treatment for the first 2 courses of therapy will last about 2 months. Treatment on this study will consist of a combination of 8 anti-cancer medications. The 8 anticancer medicines are ABT-751, dexamethasone, PEG-asparaginase, doxorubicin, cytarabine (Ara-C), methotrexate (MTX), cyclophosphamide, and 6-thioguanine. All the drugs except ABT-751 are well known anti-cancer drugs and have been used extensively in the treatment of cancer. During the Phase I portion of this study, when you enroll, you will be given an assigned dose of ABT-751. The dose of ABT-751 will be based on doses given in previous studies done with adults and children. At each dose level of ABT-751, between 3 and 6 children will receive ABT-751 in combination with chemotherapy. If the side effects are not too severe, the next group of children will receive a higher dose. The dose will continue to be increased until we find the dose that causes serious side effects. Your dose of ABT-751 will not be increased. If you have bad side effects, your dose may be decreased. The dose used during the Phase 2 part of this study will be determined by the outcome of the Phase I study. The highest dose used in Phase I that was tolerated without serious side effects will be the one used in Phase 2. ;

Study Design

Related Conditions & MeSH terms

Acute Lymphoblastic Leukemia
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Recurrent Pediatric ALL
Refractory Pediatric ALL
Relapsed Pediatric ALL

Clinical Trial Details

NCT number	NCT00439296
Study type	Interventional
Source	Therapeutic Advances in Childhood Leukemia Consortium
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	May 22, 2006
Completion date	September 23, 2009

View Details

See also
Status	Clinical Trial	Phase
Suspended	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Recruiting	`NCT05772000` - Clinical Significance of Occult Central Nervous System Localization
Recruiting	`NCT05618041` - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies	N/A
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Active, not recruiting	`NCT03114865` - A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance	Phase 1/Phase 2
Not yet recruiting	`NCT06308588` - Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia	Phase 2
Recruiting	`NCT05579132` - A Phase Ib/II Study of CN201 in Precursor B-cell Acute Lymphoblastic Leukemia	Phase 1/Phase 2
Recruiting	`NCT04904588` - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide	Phase 2
Terminated	`NCT02231853` - Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections	Phase 1
Recruiting	`NCT04969601` - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings	Phase 1/Phase 2
Withdrawn	`NCT02815059` - Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone	Phase 1
Completed	`NCT00390793` - Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.	Phase 2
Recruiting	`NCT05866887` - Insomnia Prevention in Children With Acute Lymphoblastic Leukemia	N/A
Completed	`NCT00026780` - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Completed	`NCT04666025` - SARS-CoV-2 Donor-Recipient Immunity Transfer
Not yet recruiting	`NCT06350994` - Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Withdrawn	`NCT04282174` - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies	Phase 2
Not yet recruiting	`NCT04488237` - Vitamin D and Methotrexate Adverse Effects
Completed	`NCT02544438` - Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia	Phase 1/Phase 2
Completed	`NCT02188290` - Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation	N/A