Hydrocortisone Sodium Succinate for Leukemia

Phase-Based Estimates
2
Effectiveness
3
Safety
Saint Vincent Hospital and Health Care Center, Indianapolis, IN
+6 More
Hydrocortisone Sodium Succinate - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Leukemia

Study Summary

This study is evaluating whether a combination of chemotherapy drugs works better than a single drug.

See full description

Eligible Conditions

  • Leukemia
  • Leukemia, Lymphocytic, Acute, L1
  • Leukemia, Lymphoid
  • Ph-Like Acute Lymphoblastic Leukemia
  • Central Nervous System Leukemia
  • B Acute Lymphoblastic Leukemia
  • Testicular Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Hydrocortisone Sodium Succinate will improve 2 primary outcomes, 8 secondary outcomes, and 1 other outcome in patients with Leukemia. Measurement will happen over the course of Up to 90 days.

At 1 month
Induction mortality in patients with DS and HR B-ALL treated with modified Induction
At 4 years
DFS of children, adolescents, and young adults with very high-risk (VHR) B-ALL between arms (Completed effective February 15, 2017)
OS rate for VHR B-ALL patients
At 5 years
5-year DFS in patients with Down syndrome (DS) and HR B-ALL treated with modified Induction and post-Induction therapy regimen with MBFM-IMIDM
Comparison of disease-free survival (DFS) of children with high-risk (HR) B-acute lymphoblastic leukemia (ALL) (Completed effective March 19, 2018)
Overall survival (OS) rate for HR B-ALL patients
Up to 10 years
Toxicity and tolerability of Experimental arm and Control arm in patients with VHR B-ALL (Closed effective February 15, 2017)
Toxicity and tolerability of MBFM-interim maintenance intermediate dose methotrexate (IMIDM) in children with Down syndrome
Toxicity and tolerability of post-induction age-adjusted ITT compared to age-adjusted IT MTX in children with HR B-ALL (Completed effective March 19, 2018)
Up to 4 years
DFS for children and young adults with Ph-like B-ALL and a predicted tyrosine kinase inhibitor (TKI)-sensitive mutation treated with dasatinib plus MBFM-IMHDM
Up to 90 days
Change in the minimal residual disease (MRD) from end-Induction to end-Consolidation (Closed effective Amendment 6)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

8 Treatment Groups

Group II Arm A (VHR B-ALL - Control Arm)
Group I Arm A (HR B-ALL)

This trial requires 5956 total participants across 8 different treatment groups

This trial involves 8 different treatments. Hydrocortisone Sodium Succinate is the primary treatment being studied. Participants will be divided into 7 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Group I Arm A (HR B-ALL)Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.
Group III PH-like predicted TKI-sensitive kinase mutationPatients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.
Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017)Patients receive consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.
Group II Arm C (VHR B-ALL - Exp Arm 2) (CLOSED 09/12/2014)Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.
DS HR B-ALL (SER)Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.
Group I Arm B (HR B-ALL) (CLOSED 03/19/2018)Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.
DS HR B-ALL (RER)Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.
Group II Arm A (VHR B-ALL - Control Arm)Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
FDA approved
Etoposide
FDA approved
Sulfate ion
Not yet FDA approved
Dasatinib
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080
Tioguanine
FDA approved
Daunorubicin
FDA approved
Doxorubicin
FDA approved
Cytarabine
FDA approved
Dexamethasone
FDA approved
Prednisone
FDA approved
Cyclophosphamide
FDA approved
Mercaptopurine
FDA approved
Methopterin
Not yet FDA approved
Pegaspargase
FDA approved
Clofarabine
FDA approved
Levoleucovorin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 10 years for reporting.

Closest Location

Saint Vincent Hospital and Health Care Center - Indianapolis, IN

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Leukemia or one of the other 6 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:
Patients must be enrolled in study APEC14B1 and agree to be screened for eligibility in study AALL1131 before they are enrolled in AALL1131. show original
Age 1-9.99 years: WBC >= 50 000/uL
Age 10-30.99 years: Any WBC
The table lists the age of the patient and the corresponding maximum serum creatinine level show original
is a rare form of leukemia that affects the testicles show original
CNS leukemia (CNS3)
Steroid pretreatment
Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible
and at least every 2 weeks during therapy For patients with Ph-like ALL and a predicted TKI-sensitive mutation, organ function must be assessed within 3 days of study entry onto the dasatinib arm of AALL1131 and at least every 2 weeks during therapy. show original
White Blood Cell Count (WBC) Criteria

Patient Q&A Section

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

What is leukemia?

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Leukemia is a cancer involving the blood, bone marrow or other leukocytes. Leukemia typically causes a decrease in the production or function of white blood cells, which may cause a drop in blood counts and anemia. Leukemias cause a range of symptoms depending on the type, including fatigue, itching, a dry, sore mouth, weight loss, fever, and hair loss. Symptoms can worsen in the later stages of the disease.

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What are the signs of leukemia?

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The early appearance of a fever and enlargement of the spleen and liver may be signs of leukemia. A fast heart rate suggests a worsening prognosis in leukemia.\n

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Can leukemia be cured?

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When the course of disease is carefully managed, many patients can live a normal life with minimal symptoms and few relapse episodes. This is possible even when multiple relapses occur during the initial remission phase.

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What are common treatments for leukemia?

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The treatments of acute myeloid leukemia (AML) and chronic myeloid leukemia (CML) are similar. The most common treatment is standard induction chemotherapy, followed by consolidation chemotherapy. The treatment of AML and CML is often a chemo-resistant disease. There is no cure for AML or CML. Treatment of these cancers is targeted to stop tumor cell proliferation or to control damage to other parts of the body. The key to these successful treatments is careful monitoring of the disease and treatment response.

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What causes leukemia?

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Leukemia and multiple myeloma can be explained by genetic abnormalities and/or exposure to external or internal carcinogens, and these explanations may be applicable to depression as well. Treatment of depression and the causes of acute leukemia are similar.

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How many people get leukemia a year in the United States?

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Around 1 in 6 people have a malignant primary leukemia. About 1 in 3 people die of leukemia, and 1 in 3 people have a lymphoid chronic leukemia.

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Has cytarabine proven to be more effective than a placebo?

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Cytarabine given for 2 weeks showed similar efficacy in the treatment of acute myeloid leukaemia as a comparator treatment. There was a significant advantage in the number of patients who went into remission.

Unverified Answer

What does cytarabine usually treat?

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Cytarabine (ara-C, ara-C) is often used as salvage therapy after more expensive, high-dose chemotherapy. It is effective at treating some acute leukemias, including acute lymphocytic leukaemia and myelodysplastic syndromes, but is less effective than fludarabine in the treatment of acute myeloid leukaemia (and is contraindicated in acute myeloid leukaemia if the patient is an elderly patient with comorbidities). It is sometimes used as induction therapy prior to high-dose chemotherapy.

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What is the latest research for leukemia?

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The research on AML is very diverse. Results from a recent clinical trial summarizes and compares current available information, aiming to highlight some of the most relevant factors. This information will encourage physicians, and most importantly patients, to understand the complexity of this disease and to understand more about the treatment strategies available to them.

Unverified Answer

What are the common side effects of cytarabine?

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Cytosine arabinoside is a medication that is sometimes used to treat Hodgkin's disease and acute myeloid leukemia; however, it is also used recreationally as an illicit drug and the risks and benefits of doing so are not entirely clear. Cytarabine toxicity has been well described in the medical literature, and can be severe and often very severe. The risk factors for cytarabine toxicity are age, disease load, underlying comorbidities, the cumulative dose of Cytarabine, the dose per dose for a given schedule, and the presence of certain genetic causes of cytarabine hypersensitivity.

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Does leukemia run in families?

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Despite significant family history, only 1.7% of hematologic MDS patients with a HUS2 mutation had a mutation carrier in their first-degree relatives. Further study is warranted to explore whether there is heterogeneity in the family history or if the penetrance is incomplete.

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What is the primary cause of leukemia?

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While the exact etiology of CLL is poorly characterized, several hypotheses are proposed in the present paper, including environmental exposures, genetic predisposition, somatic mutations in the leukemic clone, infectious events, epigenetic factors, or a combination of these. Further studies will be needed to determine the specific pathogenic mechanisms of CLL.

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