Cladribine + Rituximab in HCL : UPDATE

Farhad Ravandi, MDProfessor of Medicine

University of Texas – M. D. AndersonCancer Center

• Can we design a regimen with higher efficacy than single agent nucleoside analogs? (with no increased toxicity)

• Can we predict those who relapse?

• Can we design a better regimen for variant HCL?

HCL - Questions

Cladribine followed by Rituximab

Days: 1 2 3 4 5 28 Weeks: 1 2 3 4 5 6 7 8

C C C C C R R R R R R R RBM BMBM

C - CladribineR - Rituximab

Enrollment and Response

Number Achieved CR (%)

Relapsed (%)

Died

Untreated 48 48 (100) 1 (2) 1 (2)*

Inevaluable 3

First relapse

14 14 (100) 0 (0) 0 (0)

HCLv 6 6 (100) 2 (33) 3 (50)**

* 1 Patient died in CR from other malignancies** 2 Patients died in CR from other malignancies

Remission Duration

Survival

P 0.001

Response to first, second, third line therapy

Else M, Cancer, 2005

P=0.00005

DFS after successive courses of NA

Else M, Cancer, 2005

Patients Treated in First RelapsePatient Prior

therapyCR1 duration

(Years)CR2 duration

(Years)

1 Cladribine 9 8.5

2 Cladribine 1 7.1

3 Cladribine 5.5 4.1

4 Cladribine 9 7.2

5 Cladribine 2.6 5.1

6 Cladribine 1 6.2

7 DCF 6.4 3.8

8 Cladribine 4.5 1.8

9 Cladribine 5.5 1.1

10 Cladribine 6 1.3

11 Cladribine 6.5 1.4

12 Rituximab 0 0.6

13 Cladribine 1 0.6

14 Cladribine 8.3 0.0

NCT00412594 - Cladribine followed by Rituximab in frontline HCL

NCT01829711 - Moxetumomab Pasudotox in relapsed HCL

NCT01841723 - Ibrutinib in relapsed HCL

NCT02034110 - Debrafenib+Trametinib in relapsed HCL

Ongoing Trials at MDACC

Thank you

fravandi@mdanderson.org

713-745-0394