Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Behaviors and Mental Disorders

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Aggression

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Patients with relapsed/refractory B-cell ALL or NHL.

Anti-CD19/4-1BB/CD3ζ CAR T-cell: autologous, unselected CD3+ lymphocytes collected from whole blood or apheresis, transfected with a lentiviral vector containing a 2nd generation chimeric antigen receptor (CAR) consisting of a scFv recognizing CD19 and dual co-stimulatory intracellular signaling domains (4-1BB and CD3ζ). All patients will receive lymphodepleting, conditioning chemotherapy in the form of cyclophosphamide (500 mg/m2/day) and fludarabine (30 mg/m2/day) on Days -5, -4, and -3 prior to a CAR T-cell intravenous, single dose administration on Day 0.

autologous CD19-directed chimeric antigen receptor (CAR) T-cells

Zack Breckenridge

Dr. Andrew Daly, MD

Dr. Peter Duggan, MD

Dr. Victor Lewis, MD

Dr. Michael P Chu, MD

Dr. Sunil Desai, MD

Dr. Peng Wang, MD

Autologous, unselected CD3+ lymphocytes collected from apheresis, transfected with a lentiviral vector containing a 2nd generation chimeric antigen receptor (CAR) consisting of a scFv recognizing CD19 and dual co-stimulatory intracellular signaling domains (4-1BB and CD3ζ).

Anti-CD19/4-1BB/CD3ζ CAR T-cell: autologous, unselected CD3+ lymphocytes collected from whole blood or apheresis, transfected with a lentiviral vector containing a 2nd generation chimeric antigen receptor (CAR) consisting of a scFv recognizing CD19 and dual co-stimulatory intracellular signaling domains (4-1BB and CD3ζ). All patients will receive lymphodepleting, conditioning chemotherapy in the form of cyclophosphamide (500 mg/m2/day) and fludarabine (30 mg/m\^2/day) on Days -5, -4, and -3 prior to a CAR T-cell intravenous, single dose administration on Day 0.

Phase 1b: Dose Finding/Escalation Dose Level 1: 0.5 x 10\^6/kg Dose Level 2: 1.0 x 10\^6/kg Dose Level 3: 2.0 x 10\^6/kg

Phase 2: Expansion Patients will receive lymphodepleting chemotherapy as indicated prior to receiving the CAR T-cell intravenous, single dose administration on Day 0 at the RP2D as identified during Phase 1b.

All enrolled patients will be included in the safety and PK analyses. All patients receiving the dose and schedule selected for expansion will be included in the efficacy and futility analyses including patients who received the selected dose and schedule in the phase 1b dose selection and dose escalation. Analysis of during phase 2 will occur using a Simon 2-stage design.

Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)

A Phase 1b/2 Multi-center, De-centralized, Dose Selection Study of Autologous CD19-directed Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)

Alberta Cancer Foundation

Canadian Cancer Trials Group

University of Alberta

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Anti-Infective Agents

Daunorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Patients in this arm will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.

Eligible patients with relapsed and/or refractory acute leukemia will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.

Chandni Dargan, MD

In this pilot study, eligible pediatric patients will be treated with 5 consecutive days of low dose daunorubicin. All patients who receive low dose daunorubicin will be evaluated daily for potential toxicity during those 5 days. Once the patient has received 5 doses of daunorubicin, subsequent therapy will be at the discretion of the primary oncology team.

Cancer remains the number one cause of non-accidental death in children with leukemia being the most common type of childhood cancer. Although cure rates for pediatric leukemia have greatly improved over the last few years, relapsed disease still carries a poor prognosis. Outcomes for children with multiply relapsed leukemia are dismal ranging from a remission rate of 25% in AML after 2 relapses falling to 17% after 3 or more relapses and 44% in ALL after 2 relapses and 27% after 3 or more relapses.

Leukemia stem cells that are resistant to chemotherapy primarily contribute to treatment failure and targeting these cells remains a challenge. Anthracyclines such as daunorubicin and doxorubicin have been the mainstays of childhood leukemia therapy for over 50 years. Prior investigations found that very low doses, significantly less than traditionally given, of doxorubicin and daunorubicin inhibit the interaction of Akt and beta catenin pathways which is known to drive the development of leukemia stem cells and chemoresistance. Mice models showed that treatment with these very low dose anthracyclines does not suppress the immune system but rather expands cancer targeting T cells while inhibiting populations known to help cancer cells evade the immune system. In addition, targeted treatment reduced immune checkpoint expression, a known cause of resistance, on leukemia stem cells, thus further sensitizing them to cytotoxic T cells. Standard doses of anthracyclines suppress hematopoiesis and in turn the immune system and thus do not permit the expression of these immunologic benefits.

Patients with relapsed and/or refractory acute lymphoblastic leukemia or acute myeloid leukemia, ages 1-21 years, will be approached to participate in this study. These patients must have pathologically confirmed ALL or AML, whose disease is refractory to two induction therapeutic attempts, or who are in 2nd or greater relapse, or who are in 1st relapse or refractory to a single therapeutic attempt but are unable to receive intensive therapy due to other comorbidities. Patients will receive daunorubicin at 6.75mg/m2 daily for 5 consecutive days for a total dose of 33.75mg/m2.

The primary objective of this study is to assess the feasibility and tolerability of low dose daunorubicin. Another objective of the study is to validate if T cell based immune responses against chemoresistant leukemia stem cells are stimulated at these lower doses of daunorubicin, in hopes to provide preliminary pediatric data for further research with the hypothesis being that targeted anthracycline treatment does in fact stimulate T cell based immune responses against chemoresistant leukemia stem cells. Samples will be analyzed by flow cytometry for stem cell and immune markers. The third primary objective is to identify pro vs anti-cancer cellular immune responses of targeted anthracycline treatment in these patients. The mechanism of low dose DNR treatment on activating immunogenic cell death (ICD) will be investigated by determining relative levels of damage-associated molecular patterns. The tumorigenic capacity of resistant populations such as LSCs expressing high levels of immune checkpoints will be tested. The secondary objective of this study is to evaluate the pharmacokinetic parameters of low dose daunorubicin in children with relapsed/refractory AML and ALL. Blood samples for evaluation of low dose daunorubicin pharmacokinetics (area under the time concentration curve, maximum concentration, elimination half-life, clearance) will be drawn prior to dosing and 5min, 20min, 40min, 1hr, 2hrs, 4hrs, 8hrs, and 24hrs only after the first day of dosing.

Once the patient has received 5 doses of daunorubicin, subsequent therapy will be at the discretion of the primary oncology team.

Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia

A Pilot Study of Targeted Daunorubicin Dosing to Overcome Chemotherapeutic Resistance in Children With Relapsed or Refractory Acute Leukemia

Feasibility failure due to progressive leukemia is defined as a rise in absolute blast count (ABC) of \>10,000/day on two consecutive days that continues to increase \>10,000/day after starting hydroxyurea.

Low dose daunorubicin will also be deemed not feasible if there is evidence of progression of extramedullary leukemia such progression of chloroma or leukemia cutis. or if the patient experiences uncontrollable nausea and/or vomiting.

Low dose daunorubicin will also be deemed not feasible if the patient experiences uncontrollable nausea and/or vomiting.

Leukemia stem cells (LSCs) are known to be resistant to chemotherapy which may lead to treatment failure. In vitro studies have shown that targeted anthracycline treatment reduces immune checkpoint expression on LSCs, potentially sensitizing LSCs to cytotoxic T-cells. This will be measured in our study.

Chemotherapy is typically administered at maximum tolerated doses which leads to secondary immunosuppression. In other words, beneficial immunologic side effects can be weakened if chemotherapy is given at high doses. The Wnt pathway (which plays a key role in chemoresistance of LSCs) reduces T cell recruitment to tumors. Available data in murine models indicates that targeted anthracycline treatment expands cancer-targeting T-cells while inhibiting populations known to help cancer cells evade the immune system. This will be measured in our study.

Serial daunorubicin levels for evaluation of maximum concentration will be drawn prior to infusion and at 5, 20 and 40 minutes and at hours 1,2,4,8 and 24 post infusion.

Serial daunorubicin levels for evaluation of time at maximum concentration will be drawn prior to infusion and at 5, 20 and 40 minutes and hours 1,2,4,8 and 24 post infusion.

Serial daunorubicin levels for evaluation of exposure by measuring area under the curve will be drawn prior to infusion and at 5, 20 and 40 minutes and hours 1,2,4,8 and 24 post infusion.

Serial daunorubicin levels for evaluation of exposure by measuring elimination half-life will be drawn prior to infusion and at 5, 20 and 40 minutes and hours 1,2,4,8 and 24 post infusion.

Children's Mercy Hospital Kansas City

Patients in this arm will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.

Daunorubicin: Eligible patients with relapsed and/or refractory acute leukemia will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.

Patients With Relapsed/Refractory ALL and AML

Age, Categorical

Sex: Female, Male

African American

Race/Ethnicity, Customized

United States

Region of Enrollment

Dr. Alan Gamis

Data collected but analysis not performed due to small number of participants and inability to run analysis without more samples

Incidence of Low Dose Daunorubicin Feasbility as Assessed by Absolute Blast Count

Incidence of Low Dose Daunorubicin Feasbility as Assessed by Extramedullary Leukemia Progression

Incidence of Low Dose Daunorubicin Feasbility as Assessed by Patient Symptoms

This particular outcome measure requires analysis to be run in the laboratory. This was not performed and therefore there is not data to report.

T-cell Based Immune Responses Against Chemoresistant Leukemia Stem Cells (LSC) Are Stimulated at Lower Doses of Daunorubicin to Provide Preliminary Data for Further Research.

The Pro- vs. Anti-cancer Cellular Immune Response of Targeted Anthracycline Treatment in Patients With Relapsed/Refractory Acute Leukemia

Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Maximum Concentration.

Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Time at Maximum Concentration.

Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Area Under the Curve.

Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Elimination Half-life

Overall Study

Symptoms and General Pathology

Recurrence

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cytarabine

Doxorubicin

Liposomal doxorubicin

Dexamethasone

Methotrexate

Vincristine

Bortezomib

Dexamethasone acetate

BB 1101

Pegaspargase

Asparaginase

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

Intervention: Bortezomib with chemotherapy (dexamethasone, PEG-asparaginase, doxorubicin, cytarabine, methotrexate, and vincristine) and Triple IT therapy for patients who are CNS 2 or 3 at study entry. 3+3 escalation design.

Intervention: Bortezomib with chemotherapy (dexamethasone, PEG-asparaginase, doxorubicin, cytarabine, methotrexate, and vincristine) and Triple IT therapy for patients who are CNS 2 or 3 at study entry. Patients receive bortezomib at maximum tolerated dose (as established in the Phase 1 portion of the study) and are assessed for response and toxicity.

Intravenous on days 1, 4, 8 and 11. Dose assigned at study entry.

10 mg/m2/day divided BID, oral administration for 14 days.

2500 IU/m2/day, intramuscular injection on Days 2, 8, 15 and 22

PEG-asparaginase

Given intrathecally on Day 1 of course 1 at the dose defined by age below.

* 30 mg for patients age 1-1.99
* 50 mg for patients age 2-2.99
* 70 mg for patients \>3 years of age

Given intrathecally to all patients who are CNS 1 at study entry on Day 15 at the dose defined by age below.

* 8 mg for patients age 1-1.99
* 10 mg for patients age 2-2.99
* 12 mg for patients 3-8.99 years of age
* 15 mg for patients \>9 years of age

1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22.

Triple IT therapy will be given intrathecally on Day 8, 15, and 22 for patients who are CNS 2 and CNS 3 at study entry. Regimen/dosing as follows:

Methotrexate-

* \<2 years: 8 mg
* 2 - \<3 y: 10 mg
* 3 - \<9 y: 12 mg
* \>=9 y: 15 mg

Cytarabine:

* \<2 years: 16 mg
* 2 - \<3 y: 20 mg
* 3 - \<9 y: 24 mg
* \>=9 y: 30 mg

Hydrocortisone:

* \<2 years: 8 mg
* 2 - \<3 y: 10 mg
* 3 - \<9 y: 12 mg
* \>=9 y: 15 mg

Triple IT Therapy

Yoav Messinger, MD

This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.

All patients will receive 1 course of chemotherapy unless medical complications prevent the administration of some of the drugs. Treatment will last about 1 month.

Treatment on this study will consist of a combination of 7 anti-cancer medications. The 7 anti-cancer medicines are bortezomib, vincristine, dexamethasone, PEG-asparaginase, doxorubicin, cytarabine (Ara-C), and methotrexate (MTX).

If you are in the Phase I portion of this study, you will be given an assigned dose of bortezomib. The dose of bortezomib will be based on doses given in previous studies done with adults and children. At each dose level of bortezomib, between 3 and 6 children will receive bortezomib 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 bortezomib 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.

Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia

Toxicity will be graded using the CTCAE criteria, version 3.0. Dose-limiting toxicity will be defined as any of the following events that are deemed by the investigator as possibly, probably or definitely attributable to bortezomib: Grade 3 or 4 Sensory Neuropathy; Grade 3 or 4 Neuropathic pain (Neuralgia or peripheral nerve) lasting longer than 24 hours despite medical intervention; Marrow hypoplasia, which continues 6 weeks from the start of each course (less than 10% cellularity); and Grade 4 Non-Hematologic Toxicity excluding the following: Infection (septic shock, typhlitis), Fever/Neutropenia, Fatigue, Electrolyte abnormalities, Hyper/Hypoglycemia, Nausea or Vomiting, AST/ALT/Bilirubin elevations that return to grade 1 by the time of the next course.

* Complete Remission (CR): M1 (\< 5% blasts) BM with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC\>750/uL and platelet count \>75 000/uL);
* Complete Remission without Platelet Recovery (CRp): M1 BM with no circulating blasts or extramedullary disease and recovery of ANC (\>750/uL) but insufficient recovery of platelets (\<75 000/uL).
* Partial Remission (PR): the disappearance of circulating blasts and achievement of M2 (5%-25% blasts) marrow status, without new sites of extramedullary disease, and with recovery of ANC (\>750/uL).
* Stable disease (SD): not satisfying the criterion for progressive disease (PD), or a recovery of ANC (\>750/uL) but fails to qualify for CR, CRp, or PR.
* Progressive Disease (PD): increase of at least 25% in the absolute number of circulating leukemia cells, development of new sites of extramedullary disease, or other lab or clinical evidence of PD, with or without recovery of ANC or platelets.

Therapeutic Advances in Childhood Leukemia Consortium

The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions.

For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record.

Patients were evaluated regularly by the treating physician.

Patients receiving a 1 mg/m2 dose of bortezomib (known as Dose Level 1 in the Phase 1 portion). All patients in this group were from the Phase 1 portion of the study.

1 mg/m2 Dose Group

Patients receiving a 1.3 mg/m2 dose of bortezomib (known as Dose Level 2 in the Phase 1 portion). This group includes patients from both the Phase 1 and Phase 2 portions of the study.

1.3 mg/m2 Dose Group

Bortezomib (Velcade): Intravenous on days 1, 4, 8 and 11, dose-escalation

Dexamethasone: Intravenous or oral administration for 14 days.

PEG-asparaginase: Intramuscular injection

Doxorubicin: Intravenous infusion

Cytarabine: Intrathecal administration on day 1

Methotrexate: Intrathecal administration

Vincristine: Intravenous push on days 1, 8, 15, 22

The starting dose level of bortezomib will be 1 mg/m2/day given 2x week for 2 weeks on Days 1, 4, 8, and 11. The dose will be escalated to 1.3 mg/m2/day assuming that the maximum tolerated dose (MTD) is not exceeded. If the MTD is exceeded, the study will back down to the next whole dose level.

Phase 1 Dose Level 1

If the MTD is not exceeded at Dose Level 1, the next group of patients enrolled will escalate to Dose Level 2 of bortezomib at 1.3 mg/m2/day given on Days 1, 4, 8, and 11. This dose level is the highest possible dose level

Phase 1 Dose Level 2

After the MTD of bortezomib is defined with Phase 1, Phase 2 will enroll patients to receive bortezomib on Day 1, 4, 8 and 11 to evaluate activity of the regimen.

Bortezomib (Velcade): Intravenous on days 1, 4, 8 and 11 at 1.3 mg/m2/day

Dexamethasone: Intravenous or oral administration for 14 days.

PEG-asparaginase: Intramuscular injection

Doxorubicin: Intravenous infusion

Cytarabine: Intrathecal administration on day 1

Methotrexate: Intrathecal administration

Vincristine: Intravenous push on days 1, 8, 15, 22

Phase 2 Efficacy

Total

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Patients in the dose escalation group were not stratified by lineage

Lineage

Prior Treatment Attempts

Patients in the dose escalation group not stratified by previous BM transplant.

Previous Bone Marrow Transplant

Patients in the dose escalation group not stratified by leukemic blast status

Bone Marrow M3 at study entry

31 unique individual participants were enrolled into the study collectively for both Phase 1 and 2. The breakdown is as follows: 10 in the Phase I study and 21 in the Phase II study. There was, however, one patient that started on Phase I, Cohort 2 that was later eligible and rolled into the Phase II study.

Peggy Romano, BA, CCRP

Phase 1 patients receiving 1 mg/m2 dose of bortezomib

Ph 1, Dose Level 1 (1 mg/m2)

Phase 1 patients receiving 1.3 mg/m2 dose of bortezomib

Ph 1, Dose Level 2 (1.3 mg/m2)

Occurrence of a Dose-Limiting Toxicity (Phase 1)

Patients enrolled into the Phase 1 portion of the study

Ph 1 Dose Escalation

Patients enrolled into the Phase 2 portion of the study having B-Precursor ALL

Ph 2 B-Precursor ALL Patients

Patients enrolled into the Phase 2 portion of the study having T-Cell ALL

Ph 2 T-Cell ALL Patients

One Ph 1 patient received incorrect doses of Dexamethasone, so not evaluable for response. One Phase 2 patient achieved BM M1 but was treated with additional chemotherapy before peripheral recovery, so response to protocol treatment could not be evaluated.

Achievement of Complete Remission (CR)

M1: Less than 5% blasts in a bone marrow aspirate and at least 200 cells counted.

M2: 5-25% blasts in a bone marrow aspirate with at least 200 cells counted. M3: Greater than 25% blasts in a bone marrow aspirate with at least 200 cells counted.

Phase 2 B-Precursor ALL Patients

Phase 2 T-cell ALL Patients

All patients who enrolled and treated under Phase 2 will be evaluated at the end of Course 1 for treatment response as indicated by measure of bone marrow (M1, M2, or M3) or patient survival if death occurred.

Bone Marrow Response

The starting dose level of bortezomib will be 1 mg/m2/day given 2x week for 2 weeks on Days 1, 4, 8, and 11. The dose will be escalated to 1.3 mg/m2/day assuming that the maximum tolerated dose (MTD) is not exceeded. If the MTD is exceeded, the study will back down to the next whole dose level.

Phase 1: Cohort 1 Bortezomib 1mg/m2/Day (Dose Level 1)

If the MTD is not exceeded at Dose Level 1, the next group of patients enrolled will escalate to Dose Level 2 of bortezomib at 1.3 mg/m2/day given on Days 1, 4, 8, and 11. This dose level is the highest possible dose level.

Phase 1: Cohort 2 Bortezomib 1.3 mg/m2/Day (Dose Level 2)

After the MTD of bortezomib is defined with Phase 1, Phase 2 will enroll patients to receive bortezomib on Day 1, 4, 8 and 11 to evaluate activity of the regimen.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)	NCT03938987	Relapsed Non Ho... Relapsed Adult ... Relapsed Pediat...	autologous CD19...	2 Years - 70 Years	University of Alberta
Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia	NCT04562792	Relapsed Pediat... Relapsed Pediat... Refractory Acut... Refractory Acut...	Daunorubicin	1 Year - 21 Years	Children's Mercy Hospital Kansas City
Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)	NCT03938987	Relapsed Non Ho... Relapsed Adult ... Relapsed Pediat...	autologous CD19...	2 Years - 70 Years	University of Alberta
Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)	NCT00440726	Acute Lymphobla...	Bortezomib Dexamethasone PEG-asparaginas... Doxorubicin Cytarabine Methotrexate Vincristine Triple IT Thera...	1 Year - 21 Years	Therapeutic Advances in Childhood Leukemia Consortium
TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia	NCT04033627	Relapsed Pediat... Acute Graft-Ver... Relapsed Pediat...	In Vitro T cell...	2 Months - 18 Years	Shanghai Children's Medical Center
A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents	NCT05334823	Acute Lymphobla... Relapsed Pediat... Refractory Acut...	pCAR-19B cells	3 Years - 21 Years	Chongqing Precision Biotech Co., Ltd
Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia	NCT04562792	Relapsed Pediat... Relapsed Pediat... Refractory Acut... Refractory Acut...	Daunorubicin	1 Year - 21 Years	Children's Mercy Hospital Kansas City

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