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Anti-metabolites

Vinblastine/Prednisone vs. Cytarabine for Histiocytosis

Phase 3
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥ 50%
Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis
Must not have
Female patients may not be pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-years and 5-years post treatment
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 30 Other Conditions
No Placebo-Only Group

Summary

This trial is comparing two treatments for Langerhans Cell Histiocytosis (LCH), a cancer that begins in LCH cells. One treatment is standard-of-care vinblastine/prednisone, while the other is cytarabine therapy. The purpose is to see if cytarabine is more effective than vinblastine/prednisone, and if so, to develop it as the new front-line therapy for LCH.

Who is the study for?
This trial is for individuals aged 0-21 with a confirmed diagnosis of Langerhans cell histiocytosis (LCH), who have not had previous chemotherapy, except steroids. They must be able to perform daily activities at least half the time and cannot have disease limited to just one skin or bone site. Those with severe kidney or liver disease unrelated to LCH, pregnant or breastfeeding females, and patients not using birth control are excluded.
What is being tested?
The study compares two treatments for LCH: vinblastine/prednisone versus cytarabine alone. It aims to determine which therapy is more effective as a first-line treatment and will use PET scans to better identify affected areas and monitor response. The study also seeks correlations between genetic markers in blood/cancer cells and treatment outcomes.
What are the potential side effects?
Potential side effects from vinblastine/prednisone may include nerve damage, constipation, jaw pain, hair loss; prednisone can cause weight gain, mood changes, high blood sugar. Cytarabine's side effects might include fever, rash, muscle ache; less commonly it can affect the liver or lungs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to perform most of my daily activities without assistance.
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My diagnosis of Langerhans cell histiocytosis is confirmed by a biopsy.
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I am 21 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-years and 5-years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-years and 5-years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to determine 1-year event-free survival (EFS) of patients treated with cytarabine monotherapy for LCH, compared directly with that of standard-of-care vinblastine/prednisone (Events include progression of LCH, relapse, or death).
Secondary study objectives
Durable responses with 2-year and 5-year EFS and OS of the patients treated with cytarabine versus vinblastine/prednisone for LCH.
Assisted Circulation
Number of risk factors for and time to development of diabetes insipidus and neurodegenerative disease.
+5 more

Side effects data

From undefined Phase 3 trial • 1734 Patients • NCT00025259
80%
Neutrophil count decreased
42%
Anemia
31%
Platelet count decreased
26%
Febrile neutropenia
18%
White blood cell decreased
16%
Infections and infestations - Other, specify
9%
Blood and lymphatic system disorders - Other, specify
5%
Lymphocyte count decreased
3%
Catheter related infection
3%
Dehydration
2%
Abdominal pain
2%
Mucositis oral
2%
Vomiting
2%
Anaphylaxis
2%
Hypokalemia
2%
Hypotension
1%
Depression
1%
Hyponatremia
1%
Hypoxia
1%
Myalgia
1%
Immune system disorders - Other, specify
1%
Dizziness
1%
Constipation
1%
Esophagitis
1%
Ileus
1%
Pain
1%
Carbon monoxide diffusing capacity decreased
1%
Hypoalbuminemia
1%
Neuralgia
1%
Peripheral sensory neuropathy
1%
Dyspnea
1%
Diarrhea
1%
Typhlitis
1%
Hyperglycemia
1%
Headache
1%
Seizure
1%
Syncope
1%
Nausea
1%
Cardiac disorders - Other, specify
1%
Hypophosphatemia
1%
Bone pain
1%
Peripheral motor neuropathy
1%
Thromboembolic event
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm III (RER With CR [ABVE-PC])
Arm I (Patients Off-therapy Before Callback-Induction Only)
Arm II (RER With CR [ABVE-PC, IFRT])
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
Arm VII (SER [ABVE-PC, IFRT])
Arm VI (SER [DECA, ABVE-PC, IFRT])
Arm V (RER With PD)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cytarabine ("experimental") armExperimental Treatment1 Intervention
On this arm, patients will receive single therapy with cytarabine.
Group II: Vinblastine/prednisone ("standard") armActive Control1 Intervention
On this arm, patients will receive standard-of-care therapy with vinblastine and prednisone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,371 Total Patients Enrolled
Olive Eckstein, MDStudy Chair - Baylor College of Medicine
Baylor College of Medicine

Media Library

Cytarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02670707 — Phase 3
Langerhans Cell Histiocytosis Research Study Groups: Cytarabine ("experimental") arm, Vinblastine/prednisone ("standard") arm
Langerhans Cell Histiocytosis Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT02670707 — Phase 3
Cytarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02670707 — Phase 3
~1 spots leftby Jan 2025
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