| CTRI Number |
CTRI/2020/07/026937 [Registered on: 31/07/2020] Trial Registered Prospectively |
| Last Modified On: |
06/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Novel, out-patient based oral combination therapy for children with Langerhans cell histiocytosis that has relapsed or is refractory to therapy |
|
Scientific Title of Study
|
Prospective Collaborative Study for pulse dexamethasone and lenalidomide in Relapsed / Refractory Langerhans cell histiocytosis (LENDEXLCH study)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Indian Pediatric Oncology Group number: INPOG-HIST-19-03 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAMYA UPPULURI |
| Designation |
CONSULTANT |
| Affiliation |
APOLLO HOSPITALS |
| Address |
DEPARTMENT OF PEDIATRIC HEMATOLOGY, ONCOLOGY, BLOOD AND MARROW TRANSPLANTATION, APOLLO HOSPITALS, 320, PADMA COMPLEX, ANNA SALAI, TEYNAMPET, CHENNAI 600035
320, PADMA COMPLEX, ANNA SALAI, TEYNAMPET, CHENNAI-600035
Chennai
TAMIL NADU
600035
India |
| Phone |
8939710906 |
| Fax |
|
| Email |
ramya.december@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAMYA UPPULURI |
| Designation |
CONSULTANT |
| Affiliation |
APOLLO HOSPITALS |
| Address |
DEPARTMENT OF PEDIATRIC HEMATOLOGY, ONCOLOGY, BLOOD AND MARROW TRANSPLANTATION, APOLLO HOSPITALS, 320, PADMA COMPLEX, ANNA SALAI, TEYNAMPET, CHENNAI-600035
320, PADMA COMPLEX, ANNA SALAI, TEYNAMPET, CHENNAI-600035
Chennai
TAMIL NADU
600035
India |
| Phone |
8939710906 |
| Fax |
|
| Email |
ramya.december@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAMYA UPPULURI |
| Designation |
CONSULTANT |
| Affiliation |
APOLLO HOSPITALS |
| Address |
DEPARTMENT OF PEDIATRIC HEMATOLOGY, ONCOLOGY, BLOOD AND MARROW TRANSPLANTATION, APOLLO HOSPITALS, 320, PADMA COMPLEX, ANNA SALAI, TEYNAMPET, CHENNAI-600035
320, PADMA COMPLEX, ANNA SALAI, TEYNAMPET, CHENNAI-600035
Chennai
TAMIL NADU
600035
India |
| Phone |
8939710906 |
| Fax |
|
| Email |
ramya.december@gmail.com |
|
|
Source of Monetary or Material Support
|
| NO FUNDING
APOLLO HOSPITALS, 320, PADMA COMPLEX, ANNA SALAI, TEYNAMPET, CHENNAI-600035 |
|
|
Primary Sponsor
|
| Name |
RAMYA UPPULURI |
| Address |
APOLLO HOSPITALS, 320, PADMA COMPLEX, ANNA SALAI, TEYNAMPET, CHENNAI-600035 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RAMYA UPPULURI |
APOLLO HOSPITALS |
320, PADMA COMPLEX, ANNA SALAI, TEYNAMPET, CHENNAI-600035
Chennai
TAMIL NADU |
8939710906
ramya.december@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-BIOMEDICAL RESEARCH APOLLO HOSPITALS, CHENNAI |
Approved |
| TATA MEMORIAL HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C960||Multifocal and multisystemic (disseminated) Langerhans-cell histiocytosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
PULSE DEXAMETHASONE AND LENALIDOMIDE |
THE COMBINATION IS GIVEN FOR SIX CYCLES WITH EACH CYCLE FOR 28 DAYS. LENALIDOMIDE IS GIVEN FOR 21/28 DAYS, PULSE DEXAMETHASONE ONCE A WEEK |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients from 1 year of age to 18 years of age with biopsy proven LCH
2. Relapsed or refractory disease after having received 6 to 12 weeks of induction chemotherapy with Vinblastine plus prednisolone as per LCH II or III protocol
3. Relapsed or refractory disease after receiving salvage chemotherapy with cladribine +/- cytarabine can also be included
4. Patients with low-risk disease at the time of relapse may be offered LenDex upfront
5. Patients with high-risk disease at the time of relapse may be offered LenDex upfront or after salvage treatment, based on the discretion of the treating physician
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy or lactation
2. Patients with renal impairment defined as a serum creatinine > 1
3. Patients with liver impairment (excluding those due to disease) defined as SGPT and/or PT more than 5 times the upper limit of normal
4. Patients with pre-existing peripheral neuropathy
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Response to six cycles of chemotherapy
2. Event free survival and Overall Survival for all patients treated as per this protocol
3. Adverse effects of the drugs noted during and post treatment
4. Correlation of risk factors at the time of enrolment in the study with outcome
|
EVERY 3 MONTHS FOR THE FIRST 2 YEARS
EVERY 6 MONTHS FOR THE NEXT 2 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cost-effectiveness of the combination LenDex |
Every 6 months for 2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Relapsed / refractory Langerhans cell histiocytosis
(LCH) has been known to have a guarded prognosis. Salvage chemotherapy
protocols can be expensive with significant toxicity and increased risk of
morbidity and mortality. A combination of pulse dexamethasone and lenalidomide
is a cost-effective outpatient-based protocol which has been derived based on
the underlying pathophysiology of LCH. The proposed protocol includes six
cycles of the oral combination as a salvage treatment option for relapsed /
refractory LCH. |