Neoplasms

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Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Neurotoxicity Syndromes

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

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Antineoplastic Agents

All Drugs and Chemicals

Vincristine

Vinca Alkaloids

Tubulin Modulators

Antimitotic Agents

The pharmacokinetic behavior of vincristine in pediatric patients has not been well characterized. The present study will obtain detailed information on vincristine pharmacokinetics in patients being treated for standard risk ALL on CCG protocols 1952/1962. A limited sampling strategy will be developed, and the interpatient and intrapatient variability of vincristine pharmacokinetics in children will be studied. A correlation between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.

The pharmacokinetic behavior of vincristine in pediatric patients has not been well characterized. The present study will obtain detailed information on vincristine pharmacokinetics in patients being treated for standard risk ALL according to or on CCG protocols 1952/1962/1991. A limited sampling strategy will be developed, and the interpatient and intrapatient variability of vincristine pharmacokinetics in children will be studied. A correlation between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.

A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia

National Cancer Institute (NCI)

Anti-Infective Agents

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dermatologic Agents

Reproductive Control Agents

Cytarabine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Dexamethasone

Methotrexate

Rituximab

Dexamethasone acetate

Antimetabolites

Mesna

Antineoplastic Agents, Immunological

Immunologic Factors

Participants will receive calaspargase pegol administered over 1 hour with each cycle of Hyper-CVAD, mini-CVD, and late intensification, beginning with Cycle 1B. Responding patients will have dose reduction of HyperCVAD for Cycles 2B-4B. Participants with CD20+ ALL will also be given Rituximab once per cycle.

Hyper-CVAD consists of two combinations of drugs (courses A and B) given in an alternating fashion. The term "hyper" refers to the hyperfractionated nature of the chemotherapy, which is given in small doses, more frequently, to minimize side effects. CVAD is the acronym of the drugs in course a: cyclophosphamide, vincristine, doxorubicin and dexamethasone.

Course A: Cyclophosphamide days 1, 2 and 3. Vincristine days 4 and 11, Doxorubicin day 4, dexamethasone days 1-4 and 11-14, Cytarabine day 7. Mesna is also given orally with cyclophosphamide, to reduce the incidence of haemorrhagic cystitis, a common side effect of cyclophosphamide. Methotrexate, an antimetabolite, may be given when necessary to get chemotherapy past the blood brain barrier.

Course B: Methotrexate Day 1 and Cytarabine Days 2 and 3. Dosage is individualized to the patient.

Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy)

Calaspargase pegol 2000 IU/m\^2 (capped at 3750 IU) will be administered beginning in cycle 1B of Hyper-CVAD, and will continue at this dose for the duration of the trial.

Calaspargase Pegol

Rituximab 375mg/m\^2 will be administered once per cycle for patients with CD20+ ALL.

Waleed Kelada

Bijal Shah, MD

Julio Chavez, MD, MS

Sameh Gaballa, MD

Leidy Isenalumhe, MD, MS

Hayder Saeed, MD

Lubomir Sokol, MD, PhD

The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

A Single-Arm, Open-Label Phase 1b Study of Hyper-CVAD + Calaspargase Pegol in Young Adults With Newly Diagnosed Acute Lymphoblastic Leukemia

Mortality rate is hypothesized to be less than 10% when combining calaspargase pegol with Hyper-CVAD.

Minimal Residual Disease (MRD) will be studied as a dichotomous endpoint using a cutoff of 1x10\^4 cells/transcripts as the lower limit for residual leukemia and presented as the percentage of patients reaching this landmark as their best response. MRD assessment will be obtained with each bone marrow biopsy assessment, every 3 months in the first year following their last cycle of therapy and every 6 months in the subsequent 2 years following their last cycle.

Progression Free Survival defined as the time from start of treatment to the time of progression or death.

Overall Survival (OS) will be measured from the initial date of treatment to the recorded date of death.

Servier

H. Lee Moffitt Cancer Center and Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia	NCT00001689	Acute Lymphocyt... Leukemia	Vincristine	-	National Institutes of Health Clinical Center (CC)
A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia	NCT00001689	Acute Lymphocyt... Leukemia	Vincristine	-	National Institutes of Health Clinical Center (CC)
CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)	NCT05581030	Acute Lymphobla...	Hyper CVAD Prot... Calaspargase Pe... Rituximab	18 Years - 50 Years	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for a.l.l.

Every month we try and update this database with for a.l.l. cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for a.l.l.

Every month we try and update this database with for a.l.l. cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for a.l.l. cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.