Pediatric Clinical Trials

Pediatric Leukemia/MDS

If you would like to inquire about all open trials, please contact 919.684.3401.

12 trials identified.

AALL08B1 Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Phase: N/A
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Dr. Susan Kreissman
Phone: 919.684.3401
Purpose: This research trial studies a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.
Reference Number: 00025867
View this trial at ClinicalTrials.gov

AALL0932 Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Dr. Susan Kreissman
Phone: 919.684.3401
Purpose: This partially randomized phase III trial studies different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
Reference Number: 00025879
View this trial at ClinicalTrials.gov

AAML1031 A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND#69896, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Dr. Susan Kreissman
Phone: 919.684.3401
Purpose: This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.
Reference Number: 00031615
View this trial at ClinicalTrials.gov

AALL1131 A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) including a Stratum Evaluating Dasatinib (IND#73789, NSC #732517) in Patients with Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Pediatric Oncology Clinical Trials Office
Phone: 919.684.3401
Purpose: This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
Reference Number: 00034203
View this trial at ClinicalTrials.gov

ACCL1033 A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL
Phase: N/A
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Dr. Susan Kreissman
Phone: 919.684.3401
Purpose: This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia in remission. Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.
Reference Number: 00053228
View this trial at ClinicalTrials.gov

CCTL019B2205J- A Phase II, single arm, multicenter trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed or refractory B-cell acute lymphoblastic leukemia
Phase: Phase II
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Paul Martin
Contact: Jennifer Baker, RN
Phone: 919.668.1100
Purpose: This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell acute lymphoblastic leukemia, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.
Reference Number: 00057441
View this trial at ClinicalTrials.gov

AALL1231 A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Dr. Susan Kreissman
Phone: 919.684.3401
Purpose: This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Reference Number: 00059538
View this trial at ClinicalTrials.gov

AALL1331 Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Dr. Susan Kreissman
Phone: 919.6843401
Purpose: This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.
Reference Number: 00060960
View this trial at ClinicalTrials.gov

A PHASE I/II STUDY OF THE SELECTIVE INHIBITOR OF NUCLEAR EXPORT SELINEXOR (KPT-330) IN COMBINATION WITH FLUDARABINE AND CYTARABINE IN PEDIATRIC PATIENTS WITH REFRACTORY OR RELAPSED LEUKEMIA OR MYELODYSPLASTIC SYNDROME IND#122,979
Phase: Phase II
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Daniel Wechsler
Contact: Dr. Daniel Wechsler
Phone: 919.684.3401
Purpose: The purpose of this study is to test the safety of selinexor (KPT-330) and to find the highest dose of selinexor (KPT-330) that can be given safely when it is combined with two chemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: Phase I and Phase II. The goal of Phase I is to find the highest tolerable dose of selinexor (KPT-330) that we can give to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine. The goal of the subsequent Phase II portion of the study (insert NCT ID of SELHEM-2) is to give the highest dose of selinexor (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe for children with leukemia or MDS. The investigators will examine the effect of this combination treatment. PRIMARY OBJECTIVE: - Determine a tolerable combination of selinexor, fludarabine, and cytarabine in pediatric patients with relapsed or refractory hematologic malignancies included acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute leukemia (MPAL) and myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: - To characterize the pharmacokinetics of selinexor, when administered in tablet form, after the first dose and at steady-state, as well as in combination with fludarabine and cytarabine - To estimate the overall response rate of selinexor given with fludarabine and cytarabine in patients with relapsed or refractory hematologic malignancies
Reference Number: 00062654
View this trial at ClinicalTrials.gov

APEC14B1 Project:EveryChild A Registry, Eligibility Screening, Biology and Outcome Study
Phase: N/A
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Pediatric Oncology Clinical Trials Office
Phone: 919.684.3401
Purpose: This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.
Reference Number: 00068349
View this trial at ClinicalTrials.gov

AAML1331 A Phase III Study for Patients with Newly Diagnosed Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide and All-Trans Retinoic Acid
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Susan Kreissman, MD
Phone: 919.684.3401
Purpose: This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.
Reference Number: 00069267
View this trial at ClinicalTrials.gov

AAML1531 Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Pediatric Oncology Clinical Trials Office
Phone: 919.684.3401
Purpose: This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.
Reference Number: 00070111
View this trial at ClinicalTrials.gov