NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

ECOG-ACRIN E1910 - "A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please follow the "Full Protocol" link or contact NCORP-KC for complete protocol information.



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Leukemia Clinical Trial

CANCER TYPE: Acute
RESEARCH BASE: CTSU E1910
NCT NUMBER: 02003222
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

ALL, new dx, B-lineage BCR/ABL negative, age >=30 & <=70, BM & perip blood must be submitted pre-regist; Eval of Blinatumomab.  DCP-001 Eligible



NOTES


Treatment Plan     (Supplied Drug:  Blinatumomab)

 

PRE-REGISTRATION

Centralized immunophenotyping to determine pt eligibility

REGISTRATION - STEP 1 INDUCTION (ARM A)

Arm A, Cycle 1 - Cytarabine, Daunorubicin, Vincristine, Dexamethasone, Methotrexate, & Pegaspargase - Minimal Residual Disease (MRD) asmt Day 28

Arm A, Cycle 2 - Cyclophosphamide, Cytarabine, 6-Mercaptopurine, Pegaspargase, Methotrexate

If No CR ---> Off Treatment

If CR or CRi ---> STEP 2 INTENSIFICATION (ARM B)

STEP 2 INTENSIFICATION (ARM B)

1 Cycle only:  Methotrexate, Pegaspargase, Leucovorin rescue - MRD asmt at time of count recovery

STEP 3 RANDOMIZATION

ARM C - BLINATUMOMAB

Blinatumomab:  28mcg/day, CI, x 28 days, Cycle 1 followed by 2 wks rest

Blinatumomab:  28mcg/day, CI, x 28 days, Cycle 2 - MRD asmt 2 wks after completion of Cycle 2

Allogeneic BMT:  For those w/suitable donor who elect BMT.  May receive <2 cycles of Consolidation chemo b/f transplant.  MRD asmt Day 100.

OR

Consolidation Cycle 1:  Cytarabine, Etoposide, Methotrexate, Pegaspargase

Consolidation Cycle 2:  Cytarabine, Etoposide, Methotrexate

Consolidation Cycle 3:  Daunorubicin, Vincristine, Dexamethasone, Methotrexate, Cyclophosphamide, Cytarabine, 6-Mercaptopurine

Consolidation Cycle 4 (for those initially randomized to Blinatumomab):  Blinatumomab, 28 mcg/day, CI, x 28 days

Consolidation Cycle 5:  Cytarabine, Etoposide, Methotrexate

Consolidation Cycle 6 (for those initially randomized to Blinatumomab):  Blinatumomab, 28 mcg/day, CI, x 28 days

STEP 4 REGISTRATION - MAINTENANCE (ARM E)

Vincristine, Prednisone, 6-Mercaptopurine, Methotrexate:  Continue x 2.5 yrs from start of Intensification (Arm B)

 

 

ARM D - NO BLINATUMOMAB (Proceed directly to allogeneic BMT or Consolidation chemo)

Allogeneic BMT:  For those w/suitable donor who elect BMT.  May receive <3 cycles of Consolidation chemo b/f transplant.  MRD asmt Day 100.

OR

Consolidation Cycle 1:  Cytarabine, Etoposide, Methotrexate, Pegaspargase

Consolidation Cycle 2:  Cytarabine, Etoposide, Methotrexate - MRD asmt at time of count recovery (no Blinatumomab arm only)

Consolidation Cycle 3:  Daunorubicin, Vincristine, Dexamethasone, Methotrexate, Cyclophosphamide, Cytarabine, 6-Mercaptopurine

Consolidation Cycle 4:  Cytarabine, Etoposide, Methotrexate - MRD asmt at time of count recovery (no Blinatumomab arm only)

STEP 4 REGISTRATION - MAINTENANCE (ARM E)

Vincristine, Prednisone, 6-Mercaptopurine, Methotrexate:  Continue x 2.5 yrs from start of Intensification (Arm B)



ELIGIBILITY

PRE-REGISTRATION

  • Diagnostic bone marrow and/or peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing, and the establishment of BCR/ABL status. Testing will be performed by the ECOG-ACRIN Leukemia Translational Research Laboratory (LTRL) and reported to the institution.  IT IS ESSENTIAL THAT A SAMPLE CONTAINING SUFFICIENT BLAST CELLS BE SUBMITTED TO THE ECOG-ACRIN LTRL AT BASELINE SO THAT SUBSEQUENT BONE MARROW ASSESSMENTS OF MRD CAN BE DONE.

INDUCTION - STEP 1 (SEE PROTOCOL FOR STEPS 2, 3, & 4 ELIGIBILITY CRITERIA)

  • Age >30 & <70.  New dx of B lineage ALL made on BM or perip blood immunophenotyping.  Myeloid antigen expression, but unequivocal lymphoid immunophenotype is allowed.
  • No Mature B ALL (Burkitt's-like leukemia).
  • Negativity for Philadelphia chromosome by conventional cytogenetics, FISH &/or PCR.  If negative for Philadelphia chromosome by conventional cytogenetics, must have FISH or PCT for BCR/ABL to r/o occult translocations.
  • Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts from peripheral blood. FISH testing for common B-lineage ALL abnormalities including t(9;22) (BCR/ABL1), t(12;21) (ETV6/RUNX1), t(1;19) (PBX1/TCF3), +4,+10,+17, (Cen4/Cen10/Cen17), t(11q23;var), (MLL), del(9p) (CDKN2A/Cen9), and t(14;var) (IGH is encouraged. If there are few or no circulating blasts and an adequate marrow sample cannot be obtained for cytogenetic analysis, the patient may still enroll on the trial.
  • No concurrent active malignancy currently under treatment.
  • Have lab values obtained ≤ 48 hours prior to registration. Serum direct bilirubin < 2 mg/dl or serum total bilirubin ≤ 3, and serum creatinine < 2 mg/dl.
  • HLA typing (A, B, C, DR, & DQ) during Induction phase, or written explanation for not undergoing HLA typing on flow sheet.
  • No intercurrent organ damage or medical problems that will jeopardize therapy outcome.
  • No HIV infected pts.
  • No antecedent hematologic disorder.
  • No MI w/i past 3 mos, uncontrolled CHF, or uncontrolled cardiac arrhythmia.
  • No prior or current clinically relevant CNS pathology (see 3.2.12 for examples).
  • Normal cardiac ejection fx by pre-tx MUGA or Echo w/i 4 wks pre-regist (resting ejection fx >40% or >5% increase w/exercise), shortening fraction by Echo >24%, or to within normal range for the site.
  • No active uncontrolled infection.
  • No pregnant or nursing women.  Negative blood/urine pregnancy test w/i 2 wks pre-regist (if applicable).
  • Men/Women of reproductive potential must use 2 highly effective forms of contraception during protocol therapy & x 3 mos after last dose of protocol therapy.
  • ECOG perf status 0-3.
  • PRE-STUDY REQUIREMENTS*
    • H&P, ht, wt
    • CBC/diff/platelets
    • HLA typing (if considered SCT candidates; high resolution Class I & II typing should be done)
    • Serum Na, K, Ca, creat, PO4, Mg, urates
    • Serum bili, SGOT, SGPT, alk phos, LDH
    • PT, aPTT, Fibrinogen, D-dimer
    • CXR
    • Lumbar puncture (Day 1 of induction arm A)
    • ECG
    • Cardiac Ejection Fraction (MUGA/Echo)
    • BM aspirate, bx, & cytogenetics
    • Serum or Urine pregnancy test (if applicable)
    • BM aspir for MRD (heparin, FIRST PULL; MANDATORY)#
    • Perip blood (heparin, green or purple EDTA tubes, 30-40mL; MANDATORY)#
    • BM/Perip blood smears (Wright-Giemsa stained; MANDATORY)#
    • Karotypes (submit to ECOG-ACRIN Cytogenetic Lab)**
    • Perip blood (SST, serum 5mL tube) - pts receiving Blinatumomab; contact NCORP-KC for kit; submit to LabConnect**
    • Perip blood (red top, 15-20mL)***
    • Buccal Rinse (preferred) or Swab***
  • Signed informed consent.  

*         All pre-study scans/xrays <4 wks pre-regist.  <2 wks pre-regist if used to document meas or eval disease.

           CBC/diff/platelets & LFTs <48 hrs pre-regist.
           Pre-study chemistries <1 wk pre-regist, unless required on Day 1 per protocol.  If abnormal, repeat w/i 48 hrs pre-regist.

           Pre-study BM bx & aspirate <1 wk pre-regist.    

           See §10 for specimen submission instructions.

**       Prior to start of tx (Step 1)
***     With pt's consent

#         Submit to ECOG-ACRIN Leukemia Translational Studies Lab.  Must notify Dr. Paietta by phone on day of shipment.






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