| CTRI Number |
CTRI/2019/05/019350 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
22/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of acute cancers with addition of Bortezomib |
|
Scientific Title of Study
|
A single arm phase 2 study with addition of Bortezomib to standard induction chemotherapy in adult acute lymphoblastic leukemia |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anu Korula |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room no 5, Department of Haematology,
Christian Medical College,
Vellore, 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282352 |
| Fax |
04162226449 |
| Email |
anukorula@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Anu Korula |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room no 5, Department of Haematology,
Christian Medical College,
Vellore, 632004
TAMIL NADU
632004
India |
| Phone |
04162282352 |
| Fax |
04162226449 |
| Email |
anukorula@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Anu Korula |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room no 5, Department of Haematology,
Christian Medical College,
Vellore, 632004
TAMIL NADU
632004
India |
| Phone |
04162282352 |
| Fax |
04162226449 |
| Email |
anukorula@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Haematology, Christian Medical College Vellore, 632004, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore Investigator initiated Academic study |
| Address |
Department of Haematology,
Christian Medical College, Vellore, 632004, Tamil Nadu, India |
| Type of Sponsor |
Other [Charitable trust hospital] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anu Korula |
Christian Medical College |
Room no:05, Department of Haematology, Christian Medical College, Vellore, 632004, Tamil Nadu, India
Vellore
TAMIL NADU |
04162282352
04162226449
anukorula@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Silver |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bortezomib |
Bortezomib 1.3mg/m2 once a week x 4 doses |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Signed and dated written informed consent by start date of Screening visit in accordance with GCP and local legislation
2. Patients 40-60yrs of age with newly diagnosed B –cell Acute lymphoblastic leukemia |
|
| ExclusionCriteria |
| Details |
i. Pre-existing neuropathy – as detected by either NCV or clinical examination
ii. Philadelphia Positive acute lymphoblastic leukemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of peripheral neuropathy post-induction (defined according to NIH criteria)21 Grade 2 by clinical assessment by NCIC-CTC grading
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of morphological remission (assessment by bone marrow morphological examination as part of standard therapy)
2. Incidence of Minimal residual disease positivity (assessment by flow cytometry as part of standard therapy)
3. Incidence of subclinical peripheral neuropathy (detected by NCV) |
6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
10/06/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The results of this study will be published in reputed National and International journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer, and is fatal unless treated appropriately at first presentation. Over several decades chemotherapy regimens have evolved to markedly improve outcomes in pediatric ALL, with regimens involving high dose therapy with Methotrexate. In adult patients outcomes are poor, with 5 year survival of 30-40%, hampered by adverse cytogenetic features, poor tolerance to increasing doses of chemotherapy, with prolonged cytopenia and higher incidence of infection-related mortality. Several novel agents have been used in another poor prognostic group - relapsed pediatric ALL – with encouraging results. Of these, Bortezomib, is a proteasome inhibitor which is frequently used in the treatment of multiple myeloma and relapsed lymphoma. It is well tolerated and has minimal side effects. We plan to add Bortezomib to the induction phase of chemotherapy for adult B-cell ALL, to establish the feasibility and safety, and follow this with a randomized Phase II trial using standard chemotherapy with and without the use of Bortezomib.
Background: Acute lymphoblastic leukemia (ALL) in adults is an aggressive disease, with poor long-term survival rates of 30-50%. Bortezomib has been shown to be safe and effective in the treatment of ALL in the relapsed setting, and the purpose of this study is to establish the safety of Bortezomib in newly diagnosed ALL. Methods: This is a single arm Phase II trial to test the safety of Bortezomib in addition to standard induction chemotherapy in adult B cell acute lymphoblastic leukemia. Primary Outcome:
Incidence of peripheral neuropathy post-induction (defined according to NIH criteria)21 > Grade 2 (see below) by clinical assessment
Secondary Outcomes:
Incidence of morphological remission (assessment by bone marrow morphological examination as part of standard therapy)
Incidence of Minimal residual disease positivity (assessment by flow cytometry as part of standard therapy)
Incidence of subclinical peripheral neuropathy (detected by NCV)
Target sample size and rationale: As this is a Phase II pilot study, we plan to use this protocol on 10 patients and if safety is established, a multicenter randomized trial is planned to assess efficacy (by MRD post-induction). |