Anco ash 2005 review acute leukemias feb 22 2006 charles linker md
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ANCO ASH 2005 Review Acute Leukemias Feb 22, 2006 Charles Linker MD. Abstract # 43 Mini-allo for AML Herr et al EBMT Review. Mini-allo for AML EBMT Registry. n = 204 Age 58 (median) Sib and MUD donors Regimen - Flu/Bu, Flu/TBI FU 13mo 1-yr TRM 15% 1-yr Rel 34% 1-yr LFS 50%

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Anco ash 2005 review acute leukemias feb 22 2006 charles linker md
ANCO ASH 2005 Review Acute Leukemias Feb 22, 2006Charles LinkerMD


Abstract 43 mini allo for aml herr et al ebmt review
Abstract # 43Mini-allo for AMLHerr et alEBMT Review


Mini allo for aml ebmt registry
Mini-allo for AMLEBMT Registry

n = 204

Age 58 (median)

Sib and MUD donors

Regimen - Flu/Bu, Flu/TBI

FU 13mo

1-yr TRM 15%

1-yr Rel 34%

1-yr LFS 50%

1-yr OS 62%


Abstract 47 mini allo for aml shimoni et al tel hashomer israel
Abstract # 47Mini-allo for AMLShimoni et alTel Hashomer, Israel


Mini allo aml israel
Mini-allo AMLIsrael

n = 67

Age > 55

Sib and MUD donors

Regimen - Flu/Bu

FU 22mo

2-yr TRM 8%

2-yr OS 47%

If CR1: 2-yr OS 80%, TRM 0%


Calgb 100103 phase ii study of mini allo for aml cr1 age 60
CALGB 100103Phase II Study of mini-allo for AML CR1, age > 60

Study Chair: Steve Devine

CTN co-chair: Sergio Giralt


Calgb 100103 background 1
CALGB 100103Background - 1

  • Poor results of chemotherapy

  • No signs of progress in chemotherapy

  • New approaches are warranted


Calgb 100103 calgb background data
CALGB 100103CALGB background data

  • Analysis of 600 CALGB AML age > 60 with cytogenetics

    CR 50%

    5-year OS 7% !!!

    Cytogenetics predictive of outcome


Aml cr1 age 60 dfs by cytogenetics

P<0.001

< 5 Abnormalities

5 Abnormalities

AML CR1, age > 60DFS by Cytogenetics


Aml cr1 age 60 os by cytogenetics
AML CR1, age > 60OS by Cytogenetics



Calgb 100103 background 2
CALGB 100103Background - 2

  • Results in best group are still poor (n = 276)

    CR1

    Age 60-75

    Receive first consolidation on randomized trial

  • 2-year DFS 24%

  • 3-year DFS 17%


Calgb 100103 eligibility 1
CALGB 100103Eligibility - 1

  • AML CR1

    Prior MDS, t-AML allowed

    < 2 cycles induction

    < 2 courses consolidation

    < 6 months in CR1

    exclude APL, prior MPD

  • Age 60-74

  • Matched sibling or 10/10 MUD donor


Calgb 100103 eligibility 2
CALGB 100103Eligibility - 2

  • PS 0 - 2

  • Adequate organ function

    DLCO > 40%

    EF > 30%

    Creatinine clearance > 40

    Bili < 2.0

    AST < 3x normal


Calgb 100103 preparative regimen
CALGB 100103 Preparative Regimen

  • Fludarabine 30 mg/m2 x 5 days -7 to -3

  • Busulfan 0.8 mg/kg IV x 8 days -4 to -3

  • Thymoglobulin 2.5 mg/kg x 3 days -4 to -2

  • Stem cell infusion day 0


Calgb 100103 gvh prophylaxis
CALGB 100103 GVH Prophylaxis

  • Tacrolimus day - 2 to +90

  • MTX 5 mg/m2 days, +1, 3, 6, 11

  • Taper tac day +90 to +150/+180


Calgb 100103 statistics
CALGB 100103 Statistics

  • Primary objective 2-year DFS > 35%

    90% power to exclude DFS < 20%

  • Accrual goal = 61

  • Stopping rules for TRM

    Assume true TRM 20%

    Unacceptable TRM 40%


Calgb 100103
CALGB 100103

  • Currently active in CALGB

    sib donors only

  • Amendment in process

    Add CTN

    Add MUD


Mini allo for aml age 60
Mini-allo for AML, age > 60

  • Currently treatments work poorly

  • Mini-allo is feasible

  • Several pilot studies show DFS > 40%

  • Deserves testing in Group setting

  • CALGB 100103 is last chance for USA study


Abstract 146 ph all dellanoy et al grall france
Abstract # 146Ph+ ALLDellanoy et alGRALL, France


Ph all age 55 treatment
Ph+ ALL,age > 55Treatment

  • Pre-phase

    Prednisone x 1 week

  • Induction

    CyDVP

    Imatinib 600 x 2 mo

  • Consolidation

    10 blocks of chemo

    2 x 2 mo imatinib

  • CNS-P

    i.t. mtx + cranial RT


Ph all age 55 results
Ph+ ALL, age > 55Results

N = 30

Age 66 (58 - 78)

FU 15mo

CR 20/29 ( vs 6/21 historical control)

1-yr OS 71% (11% control)

1-yr EFS 57% (5% control)


Asct for high risk all protocol 9501 soc
ASCT for high-risk ALLProtocol 9501 & SOC


Protocol 9501 soc for ph effect of imatinib
Protocol 9501 SOC for Ph+Effect of Imatinib


Ph all role of imatinib
Ph+ ALLRole of Imatinib

  • Plays major role in induction

    Safe to combine with chemotherapy

    Increases remission rate

  • Encouraging results post-remission

  • May play role in transplant

    Allo transplant is treatment of first choice

    Patients get to transplant in remission

    May reduce relapse rate

    ASCT being tested in CALGB 10001

    May allow PCR neg stem cells for ASCT


Abstract 150 nelarabine for t all goekbuget et al gmall germany
Abstract # 150Nelarabine for T-ALLGoekbuget et alGMALL, Germany


Calgb 19801 de angelo et al ash 743 2002
CALGB 19801De Angelo et alASH #743 (2002)

  • Eligibility

    T-ALL or T-LL

    Relapse or refractory

  • Treatment

    Nelarabine (GW 506U) 1.5g/m2 days 1, 3, 5

    q3 weeks x 2 cycles

    Responders may get additional 2 cycles

  • Results

    10/38 CR (26%)

    MDCR 10mo

    1-yr DFS 40%


Nelarabine patients and treatment
NelarabinePatients and Treatment

  • n = 53

  • Age 31 (19 - 81)

  • Disease category:

    First relapse 36

    Second relapse 7

    Relapse after transplant 7

    Refractory 3

  • Treatment:

    Nelarabine 1.5g/m2 days 1, 3, 5


Nelarabine results
NelarabineResults

25/53 CR (47%)

19/25 Cr go to transplant

OS 16%

OS of CR 27%


Nelarabine for t all
Nelarabine for T-ALL

  • Important new agent

  • Good choice for relapse

  • Should be tested up front


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