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Vinblastine for Langerhans Cell Histiocytosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Langerhans Cell HistiocytosisVinblastine - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
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Study Summary

This trial is for kids with a rare cancer called Langerhans Cell Histiocytosis.

Eligible Conditions
  • Langerhans Cell Histiocytosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

6 Primary · 22 Secondary · Reporting Duration: 3 Years

12 Months
Percentage of Patients with Reactivation Free Survival
2 Years
Cumulative incidence of reactivations in risk organs
Cumulative incidence of specific Permanent Consequences e.g. diabetes insipidus (DI), growth hormone deficiency (GHD), neuropsychological impairment, etc.
Early and late mortality
Early and late toxicity
Frequency of ND-CNS-LCH in patients with isolated tumorous CNS-LCH
Identify possible risk factors for permanent consequences (PC)
Incidence of Permanent Consequences
Incidence of hematopoietic recovery, and donor chimerism at d+100 and 1 year post RIC-HSCT
Methods of early identification of ND-CNS-LCH
Need for systemic therapy later during disease course
Number of Participants with Serious and Non-Serious Adverse Events
Overall Survival
Percentage of Participants with incidence of chronic GVHD
Percentage of treatment-related toxicities
Record all occurrence of skin, GI or liver abnormalities fulfilling criteria of Grades II-IV acute GVHD
Response of isolated tumorous CNS-LCH to 2-CDA
The cumulative incidence of radiological and clinical neurodegeneration in patients with isolated tumorous CNS-LCH, DI, anterior pituitary dysfunction, and those with CNS-risk lesions
The proportion of patients alive and free of disease without permanent consequences (e.g. diabetes insipidus, anterior pituitary dysfunction, radiological or clinical neurodegeneration)
The time interval and cumulative incidence of progression of radiological neurodegeneration to clinically manifested ND-CNS-LCH
The type of subsequent intensive and/or maintenance therapy utilized
Time to complete disease resolution
d+100 transplant related mortality
2 years
Reactivation rates after continuation treatment with Indomethacin vs. 6-MP/MTX.
Therapeutic procedure
Response rate to the combination of prednisone, vincristine and cytarabine
3 Years
Overall and disease free survival at 1 and 3 years after reduced intensity conditioning hematopoietic stem cell transplantation (RIC-HSCT)
9 weeks
Response Rate of Second Cycle

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Side Effects for

Arm B (Stanford V)
98%Anemia
93%Leukocytes decreased
90%Lymphopenia
84%Neutrophils decreased
78%Neuropathy-sensory
75%Alopecia
74%Fatigue
67%Nausea
60%Hyperglycemia
52%Constipation
46%Hypoalbuminemia
40%Myalgia
34%Stomatitis
33%Insomnia
32%Vomiting
27%Platelets decreased
26%Alkaline phosphatase increased
26%Aspartate aminotransferase increased
23%Dyspnea
20%Dyspepsia
19%Dysphagia
19%Headache
16%Arthralgia
16%Anorexia
15%Abdominal pain
15%Neuropathy-motor
14%Cough
14%Fever
14%Infection w/o neutropenia
13%Diarrhea w/o prior colostomy
13%Rash/desquamation
12%Bone pain
11%Weight gain
11%Taste disturbance
11%Anxiety/agitation
10%Sweating
10%Radiation dermatitis
9%Dizziness/lightheadedness
9%Rigors/chills
9%Injection site reaction
8%Pain-other
8%Phlebitis
8%Chest pain
8%Blood bilirubin increased
8%Dysphagia-esophageal radiation
8%Hypoglycemia
7%Pruritus
7%Edema
7%Creatinine increased
6%Infection w/ grade 3 or 4 neutropenia
6%Hot flashes
6%Weight loss
5%Mouth dryness
5%Depression
5%Muscle weakness
4%Pneumonitis/pulmonary infiltrates
4%Transfusion: pRBCs
3%Irregular menses
3%Febrile neutropenia
3%Nail changes
3%Thrombosis/embolism
2%Allergic rhinitis
1%Syncope
1%Sinus tachycardia
1%Infection w/ unknown ANC
1%Neuropathic pain
1%Allergic reaction
1%Dehydration
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT00003389) in the Arm B (Stanford V) ARM group. Side effects include: Anemia with 98%, Leukocytes decreased with 93%, Lymphopenia with 90%, Neutrophils decreased with 84%, Neuropathy-sensory with 78%.

Trial Design

6 Treatment Groups

Stratum II
1 of 6
Stratum VI
1 of 6
Stratum III
1 of 6
Stratum IV
1 of 6
Stratum V
1 of 6
Stratum I
1 of 6

Experimental Treatment

1400 Total Participants · 6 Treatment Groups

Primary Treatment: Vinblastine · No Placebo Group · Phase 2 & 3

Stratum IIExperimental Group · 6 Interventions: Prednisone, INDOMETHACIN, mercaptopurine, Cytosine Arabinoside, Vinblastine, Methotrexate · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Stratum VIExperimental Group · 6 Interventions: Prednisone, Intravenous immunoglobulin, mercaptopurine, Cytosine Arabinoside, Vinblastine, 2-chlorodeoxyadenosine · Intervention Types: Drug, Biological, Drug, Drug, Drug, Drug
Stratum III
Drug
Experimental Group · 1 Intervention: 2-chlorodeoxyadenosine · Intervention Types: Drug
Stratum IV
Procedure
Experimental Group · 1 Intervention: hematopoietic stem cell transplantation (RIC-HSCT) · Intervention Types: Procedure
Stratum VExperimental Group · 3 Interventions: Intravenous immunoglobulin, Cytosine Arabinoside, 2-chlorodeoxyadenosine · Intervention Types: Biological, Drug, Drug
Stratum IExperimental Group · 3 Interventions: Prednisone, mercaptopurine, Vinblastine · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Human immunoglobulin G
FDA approved
Mercaptopurine
FDA approved
Cytarabine
FDA approved
Vinblastine
FDA approved
Methotrexate
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

North American Consortium for HistiocytosisLead Sponsor
4 Previous Clinical Trials
377 Total Patients Enrolled
Histiocyte SocietyOTHER
1 Previous Clinical Trials
376 Total Patients Enrolled
Milen Minkov, MD, Ph.DStudy ChairChildren's Cancer Research Institute / St. Anna Children's Hospital
Carlos Rodriguez-Galindo, MDStudy ChairNorth American Consortium for Histiocytosis
6 Previous Clinical Trials
650 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a patient under 18 years of age.
You have been treated for Hodgkin's disease and have been free of disease for at least 5 years.
References

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