Dexrazoxane Hydrochloride for T Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates

Effectiveness

Safety

Renown Regional Medical Center, Reno, NV

T Acute Lymphoblastic Leukemia+8 More

Dexrazoxane Hydrochloride - Drug

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Eligibility

< 65

All Sexes

Eligible conditions

Select

Eligibility

< 65

All Sexes

Eligible conditions

Select

Study Summary

This study is evaluating whether a combination of drugs may help treat patients with a specific type of leukemia.

See full description

Eligible Conditions

T Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia (ALL)
Mixed Phenotype Acute Leukemia (MPAL)
B Acute Lymphoblastic Leukemia

Treatment Effectiveness

Effectiveness Progress

2 of 3

This is further along than 85% of similar trials

Other trials for T Acute Lymphoblastic Leukemia

Chemotherapy Regimen 1

Methotrexate

Venetoclax

Study Objectives

This trial is evaluating whether Dexrazoxane Hydrochloride will improve 2 primary outcomes, 16 secondary outcomes, and 10 other outcomes in patients with T Acute Lymphoblastic Leukemia. Measurement will happen over the course of Up to 6 months.

Year 3

EFS of all enrolled patients

Year 3

OS of standard risk patients

Year 3

Disease free survival (DFS)

Year 3

Overall survival (OS) of all enrolled patients

Year 3

OS of high risk patients

Year 1

Incidence of toxicities associated with post-HSCT administration of imatinib mesylate

Month 12

MRD in high risk patients measured by IGH-TCR PCR and NGS assay

Up to 2 years

Adherence to imatinib mesylate after allogeneic HSCT in high risk Ph+ ALL patients

Adherence to oral chemotherapeutic agents in standard risk Ph+ ALL patients

Feasibility of post hematopoietic stem cell transplantation (HSCT) imatinib mesylate administration after allogenic HSCT in high risk Ph+ ALL patients

Imatinib mesylate administration after allogeneic hematopoietic stem cell transplantation (HSCT) in high risk Ph+ ALL patients

Up to 3 years

DFS on Randomized Arms (SR Ph+ ALL and ABL-class fusion positive patients)

Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients)

EFS of all Ph+ patients

EFS of all eligibility ABL-class fusion positive ALL patients

Event free survival (EFS) of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate

Frequency of p190 and p210 BCR-ABL1 fusion variants

IKZF1 gene aberrations and deletions

Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms

Incidence of long-term toxicities in patients treated with chemotherapy plus imatinib mesylate (no transplant) in both arms

MRD assessments made by IGH-TCR PCR assay and NGS assay

MRD in high risk Ph+ patients measured by IGH-TCR PCR and NGS assay

OS of SR Ph+ patients

OS of SR Ph+ patients by randomization group

OS of all eligibility ABL-class fusion positive ALL patients

OS of high risk Ph+ patients

Overall survival (OS) of all Ph+ patients

Up to 6 months

MRD measured by IGH-T cell receptor (TCR) polymerase chain reaction (PCR) and next generation sequencing (NGS) assay

Trial Safety

Safety Progress

3 of 3

This is further along than 85% of similar trials

Other trials for T Acute Lymphoblastic Leukemia

Chemotherapy Regimen 1

Methotrexate

Venetoclax

Trial Design

3 Treatment Groups

Arm B (imatinib mesylate, COG/BFM chemotherapy)

1 of 3

Arm A (imatinib mesylate, EsPhALL chemotherapy)

1 of 3

Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

1 of 3

Experimental Treatment

This trial requires 475 total participants across 3 different treatment groups

This trial involves 3 different treatments. Dexrazoxane Hydrochloride is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Arm B (imatinib mesylate, COG/BFM chemotherapy)See Detailed Description.

Arm A (imatinib mesylate, EsPhALL chemotherapy)See Detailed Description

Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)See Detailed Description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexrazoxane

FDA approved

Methylprednisolone

FDA approved

Hydrocortisone acetate

FDA approved

Ifosfamide

FDA approved

Vincristine

FDA approved

Dexamethasone

FDA approved

Cyclophosphamide

FDA approved

Cytarabine

FDA approved

Levoleucovorin

FDA approved

Methotrexate

FDA approved

Tioguanine

FDA approved

Mercaptopurine

FDA approved

Hydrocortisone

FDA approved

Daunorubicin

FDA approved

Allogeneic Hematopoietic Stem Cell Transplantation

2015

Completed Phase 2

~1230

Asparaginase Escherichia coli

FDA approved

Filgrastim

FDA approved

Beta-D-Glucose

Not yet FDA approved

Daunorubicin

FDA approved

Imatinib

FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: from enrollment until the first occurrence of: m3 marrow at the end of induction ia, relapse, second malignancy, or death as a first event, assessed up to 3 years

This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from enrollment until the first occurrence of: m3 marrow at the end of induction ia, relapse, second malignancy, or death as a first event, assessed up to 3 years for reporting.

Closest Location

Renown Regional Medical Center - Reno, NV

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for T Acute Lymphoblastic Leukemia or one of the other 8 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:

The diagnostic samples will be collected and analyzed according to the procedures of the National front-line protocol. show original

Yes

Unsure

Patients should be enrolled on National ALL protocol prior to enrollment on EsPhALL2017/COGAALL1631 show original

Yes

Unsure

BCR-ABL1 fusion (Ph+): newly diagnosed ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO] definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR

Yes

Unsure

ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions identified according to National/Center procedures of each participating country. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA, LYN. Methods of detection include fluorescence in-situ hybridization (FISH, e.g. using break-apart or colocalization signals probes), multiplex or singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole transcriptome or panel-based ribonucleic acid (RNA)-sequencing

Yes

Unsure

Regardless of initial front-line protocol, laboratory reports detailing evidence of BCR-ABL1 or ABL-class fusion must be available for the National Trial Unit

Yes

Unsure

Ph+ ALL patients must have previously started induction therapy, which includes vincristine, a corticosteroid, usually PEG-L-asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy

Yes

Unsure

Ph+ ALL patients have not received more than 14 days of multiagent induction therapy beginning with the first dose of vincristine

Yes

Unsure

Ph+ ALL patients may have started imatinib prior to study entry but have not received more than 14 days of imatinib

Yes

Unsure

You have completed the 4 or 5 weeks of multiagent Induction chemotherapy. show original

Yes

Unsure

ABL-class fusion patients may have started imatinib during Induction IA, at the same time of or after the first vincristine dose

Yes

Unsure

Patient Q&A Section

Can mixed phenotype acute leukemia (mpal) be cured?

"Mopal is the most aggressive and complicated disease with an annual incidence of approximately 0.3/100,000 population. Because of this low incidence, the clinical course of Mopal is not predictable." - Anonymous Online Contributor

Unverified Answer

What are the signs of mixed phenotype acute leukemia (mpal)?

"MPAL seems to be clinically very similar to B-CLL. The distinction between both disorders is based on the molecular/cytogenetic features; MPAL seems to be more inclined to the "classic" M-CLL subtype, while B-CLL is related to the more advanced subtypes. This differentiation is important since MPAL is considered a neoplastic disease, while B-CLL is not.\n" - Anonymous Online Contributor

Unverified Answer

What is mixed phenotype acute leukemia (mpal)?

"The presence of mcl1 translocation is strongly associated with a poor response to imatinib therapy in patients with chronic myeloid leukemia and should be added to a stratification of patients with advanced chronic myeloid leukemia treated with imatinib. Findings from a recent study identifies mcl1 as the molecular basis of leukemic progression in patients with advanced chronic myeloid leukemia." - Anonymous Online Contributor

Unverified Answer

What are common treatments for mixed phenotype acute leukemia (mpal)?

"Many types of chemotherapy are used in the treatment of childhood leukemia. A majority of patients who qualify for this study will receive a course of chemotherapy at the main pediatric oncology center at UGM." - Anonymous Online Contributor

Unverified Answer

What causes mixed phenotype acute leukemia (mpal)?

"The cause of mPal is unknown. This may be due to the fact that the diagnosis and pathologic work-up of these cases are limited and that the disease frequently presents with an array of signs and symptoms." - Anonymous Online Contributor

Unverified Answer

How many people get mixed phenotype acute leukemia (mpal) a year in the United States?

"Around 1400 cases (30% of all hematologic malignancy cases) are diagnosed with (MPAL/CMML/CPAL/MPAL-like)/B-CML-CPAL annually in the United States. MPAL is rarely seen outside of the United States." - Anonymous Online Contributor

Unverified Answer

Is methylprednisolone safe for people?

"Low dose methylprednisolone is both safe and effective in a group of people with malignancies presenting with acute or chronic leukemia (n = 25) and may represent a beneficial role in combination with other antineoplastic drugs (n=16)." - Anonymous Online Contributor

Unverified Answer

Is methylprednisolone typically used in combination with any other treatments?

"Findings from a recent study suggest that methylprednisolone is the most frequently used glucocorticoid in adults with MPAL. Interestingly, the combination with prednisone is relatively infrequent compared with other combinations. However, this combination is potentially more effective than single therapy when the patient has received a minimum of two treatment cycles." - Anonymous Online Contributor

Unverified Answer

What does methylprednisolone usually treat?

"MPAL is a subtype of acute myeloid leukemia associated with an increased risk of bleeding and death. It is therefore important to control for these risks as part of clinical treatment by use of a corticosteroid such as MP." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in methylprednisolone for therapeutic use?

"Methylprednisolone can be used with success in most patients with relapsing CML, but in some patients it has been ineffective. It has been shown to be helpful in the treatment of B-CLL patients, but the results are disappointing, and the exact mechanisms are still unclear. Because of its short-term benefits and low toxicity, there are cases in which long-term use of methylprednisolone is warranted. In a recent study, findings of new studies are very promising and will provide new information on the use of steroids." - Anonymous Online Contributor

Unverified Answer

How does methylprednisolone work?

"Methylprednisolone does not change blood cell counts, but induces a rapid rise in blood cell counts following the medication. A rapid rise in neutrophils and lymphocytes after methylprednisolone treatment can interfere with detection of sub-clinical myelodysplastic syndromes (MDS) in the marrow. Methylprednisolone should be avoided if the patient has other features that indicate a need for a splenectomy." - Anonymous Online Contributor

Unverified Answer

Does methylprednisolone improve quality of life for those with mixed phenotype acute leukemia (mpal)?

"Methylprednisolone was associated with adverse treatment-related side effects and low overall QOL scores. However, it may have a positive effect on the quality of life for those with mpa." - Anonymous Online Contributor

Unverified Answer

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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