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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-years and 5-years post treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-years and 5-years post treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Blood and lymphatic system disorders - Other, specify

Lymphocyte count decreased

Catheter related infection

Dehydration

Abdominal pain

Mucositis oral

Vomiting

Anaphylaxis

Hypokalemia

Hypotension

Hypoxia

Depression

Hyponatremia

Immune system disorders - Other, specify

Myalgia

Dizziness

Constipation

Esophagitis

Ileus

Pain

Carbon monoxide diffusing capacity decreased

Hypoalbuminemia

Neuralgia

Peripheral sensory neuropathy

Dyspnea

Diarrhea

Typhlitis

Hyperglycemia

Headache

Seizure

Syncope

Nausea

Cardiac disorders - Other, specify

Hypophosphatemia

Bone pain

Peripheral motor neuropathy

Thromboembolic event

Hypertension

100%

80%

60%

40%

20%

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)

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,128 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

Frequently Asked Questions

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

Are there any other continent-based locations where this research trial is taking place?

"If you wish to enroll in this clinical trial, please choose the location closest to you from the list of 11 sites. The locations are situated in Austin, San Antonio, Houston and 11 other cities. This will help to reduce travel-related demands."

Answered by AI

How many patients are taking part in this experiment?

"Yes, this is an active trial. The most recent update was on 8/23/2022. They are looking for 124 patients that meet the requirements and are willing to visit one of the 11 locations."

Answered by AI

Can patients still join this clinical trial?

"That is correct. According to the information available on clinicaltrials.gov, this study is still looking for enrollees. The first posting was on March 7th, 2016 and the page was updated as recently as August 23rd, 2020. In total, they need 124 volunteers spread out over 11 different locations."

Answered by AI

How is Cytarabine most often utilized?

"Cytarabine is frequently used to manage thyroiditis. Additionally, this medication can be helpful in treating ulcerative colitis, varicella-zoster virus acute retinal necrosis, and brain conditions."

Answered by AI

Has Cytarabine undergone drug approval by the FDA?

"Cytarabine has been deemed safe by our team, who gave it a 3. This is due to the fact that this medication has gone through multiple clinical trials, meaning there is both efficacy and safety data available."

Answered by AI

Are there other precedents for Cytarabine research?

"578 clinical trials involving Cytarabine are currently active with 143 of those in Phase 3. Although most of these studies originate from Duarte, California, there are 23800 locations where Cytarabine trials are taking place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)

Olive Eckstein 2016. "Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02670707.

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