| CTRI Number |
CTRI/2017/09/009650 [Registered on: 05/09/2017] Trial Registered Prospectively |
| Last Modified On: |
04/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cure rate of childhood B cell lymphoma with rituximab and reduced strength of chemotherapy |
|
Scientific Title of Study
|
Rituximab with reduced dosage LMB backbone chemotherapy schedule in childhood and adolescent mature B cell lymphoma/leukemia: Evaluation of efficacy & toxicity profile in developing country setting |
| Trial Acronym |
R LMB childhood lymphoma |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaikumar GR |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute Adyar |
| Address |
Department of medical oncology,
Cancer Institute
Adyar
Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
8196800157 |
| Fax |
|
| Email |
gr_jaikumar@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaikumar GR |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute Adyar |
| Address |
Department of medical oncology,
Cancer Institute
Adyar
Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
8196800157 |
| Fax |
|
| Email |
gr_jaikumar@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Jaikumar GR |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute Adyar |
| Address |
Department of medical oncology,
Cancer Institute
Adyar
Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
8196800157 |
| Fax |
|
| Email |
gr_jaikumar@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Cancer institute
Adyar
Chennai |
|
|
Primary Sponsor
|
| Name |
Cancer Institute adyar |
| Address |
Cancer institute adyar
chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jaikumar GR |
Cancer Institute Adyar |
Department of Medical oncology
Medical oncology forum room
MOB block second floor
Prof. S. Krishnamurthi campus
Cancer institute
Adyar
Chennai
Chennai
TAMIL NADU |
8196800157
gr_jaikumar@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee Cancer institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Burkitt lymphoma and
diffuse large B cell lymphoma , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
Not applicable |
| Intervention |
Rituximab |
Intravenour rituximab will be administered with every cycle of chemotherapy. The dose will be 375mg/m2. Total of 4 doses of rituximab will be administered at a frequency of 21 days once |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. CD 20 positive Burkitt lymphoma & Diffuse large B cell lymphoma stage III & IV stage
2. CD 20 positive Burkitt lymphoma & Diffuse large B cell lymphoma stage I & II stage non-resectable
|
|
| ExclusionCriteria |
| Details |
1. Active hepatitis B infection or carriers of hepatitis B virus
2. Active hepatitis C infection or carriers of hepatitis C virus
3. HIV infected children
4. Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology
5. Follicular lymphoma, MALT, nodular marginal zone lymphoma and primary mediastinal B cell lymphoma
6. Children with cardiac dysfunction- ejection fraction < 45%
7. Pregnancy
8. Allergic to rituximab
9. Not consenting for treatment
10. Children assessed by treating physician as not fit for intensive chemotherapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of treatment schedule utilizing addition of rituximab to reduced dosage standard LMB backbone chemotherapy. |
To evaluate the efficacy of treatment schedule utilizing addition of rituximab to reduced dosage standard LMB backbone chemotherapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the toxicity profile of treatment schedule utilizing addition of rituximab to reduced dosage standard LMB backbone chemotherapy. |
During chemotherapy treatment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
18/09/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications yet from this protocol |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Mature b cell lymphoma is a curable malignancy with cure rates exceeding 90% in developed world. In developing country setting it is 70%. The lower survival rate is due tohigher treatment related toxicity and higher relapse rate. Malnutrition and delayed presentation leads to higher mortality rates. To counter higher mortality rate in malnourished children it is planned to reduce the chemotherapy dosage to 75%. The treatment intensity could be maintained if there are fewer toxicity. This would indirectly reduce the relapse rate. Dose reduction is expected to facilitate in maintaining treatment intensity To prevent relapse an additional biomolecule, rituximab, active against mature B cell lymphoma is added. In trials it has already boosted the survival rate by 15%. This would reduce the relapse rate. We expect with the strategy of reduction of chemotherapy dosage and addition of rituximab our survival rate would exceed 90%. We are conducting a pilot study testing this hypothesis and then later to expand to a phase III trial
|