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

SWOG S1712 - " A Randomized Phase II Study of Ruxolitinib in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia Patients with Evidence of Molecular Disease.

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 contact NCORP-KC for complete protocol information.



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Leukemia Clinical Trial

CANCER TYPE: Chronic
RESEARCH BASE: SWOG
NCT NUMBER:
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM
UPDATED ON 08/15/2018 (17:22:49)

BRIEF DESCRIPTION

CML w/molecular disease, Dasatinib or Nilotinib +/- Ruxolitinib.  DCP-001 Eligible



NOTES


Patients must have detectable BCR-ABL transcripts measured by RT-PCR at a CLIA-approved laboratory and reported on the International Scale (IS) with a value of > 0.0032% IS and ≤ 1.0% IS within 21 days prior to randomization.

Patients must be receiving treatment with dasatinib (within the allowable dose range of 70-100 mg daily) or nilotinib (within the allowable dose range of 200-400 mg BID) as first or second line therapy for a minimum of 6 months prior to registration.

 

Treatment Plan        (Supplied Drug:   Ruxolitinib)

Arm 1:

Dasatinib 70-100 mg^ PO, Days 1-90, once per day, max of 4 cycles

OR

Nilotinib 200-400 mg^ PO, Days 1-90, BID, max of 4 cycles

^ Within the outlined dose range, dose is at the discretion of the treating physician, and should be the same as the dose the patient was receiving prior to randomization.

Cycle = 90 days

Arm 2:

Ruxolitinib 15mg PO, Days 1-90, BID, max of 4 cycles

AND

Dasatinib 70-100 mg^ PO, Days 1-90 once per day, max of 4 cycles

OR

Nilotinib 200-400 mg^ PO, Days 1-90, BID, max of 4 cycles

^ Within the outlined dose range, dose is at the discretion of the treating physician, and should be the same as the dose the patient was receiving prior to randomization.

Cycle = 90 days

 

 



ELIGIBILITY

  • Patients must have a diagnosis of chronic phase chronic myeloid leukemia without any history of progression to accelerated or blast phase CML (as defined in Section 4.0). No new bone marrow aspiration and biopsy is needed to prove diagnosis prior to randomization; however, documentation stating the patient is in chronic phase is required.
  • Patients must have detectable BCR-ABL transcripts measured by RT-PCR at a CLIA-approved laboratory and reported on the International Scale (IS) with a value of > 0.0032% IS and ≤ 1.0% IS within 21 days prior to randomization. The RT-PCR assay must have the sensitivity to detect a 4.5 log reduction in BCR-ABL transcripts from baseline (at least 0.0032% IS).
  • Patients must be receiving treatment with dasatinib (within the allowable dose range of 70-100 mg daily) or nilotinib (within the allowable dose range of 200-400 mg BID) as first or second line therapy for a minimum of 6 months prior to registration.
  • Patients must not have received > 2 TKIs for treatment of CML (hydroxyurea prior to initiation of TKI is allowed).
    • Patients must have been on their current TKI for a minimum of 6 months prior to randomization.
    • If dasatinib or nilotinib is second-line therapy, the reason for stopping first-line treatment must not have been resistance to prior treatment or failure to achieve an adequate response on their first-line TKI (e.g., the patient could have stopped due to intolerance to prior TKI).
  • Patients must have been receiving TKI treatment for CML for at least one year and no more than 10 years prior to randomization.
  • Patients must be expected to remain on the same TKI for the next 12 months.
  • Patients must not be receiving any other investigational agents.
  • Patients must be ≥ 18 years of age.
  • Patients must have complete history and physical examination within 28 days prior to randomization.
  • Patients must have QTcF interval < 500 ms (by Fridericia calculation) on a 12-lead EKG within 7 days prior to randomization.
    QTcF = QT/(RR)0.33
    (QTcF = QT interval divided by the cube root of the RR [heart rate] in seconds)
  • Patients must have platelets ≥ 100,000/mm3 (75.0 x 109/L), ANC > 1,000/mm3 (1.0 x 109/L), and hemoglobin ≥ 8 g/dL within 7 days prior to randomization.
  • Patients must have ALT and AST ≤ 2.5 x IULN within 7 days prior to randomization.
  • Patients must have total bilirubin ≤ 1.5 x IULN within 7 days prior to randomization.
  • Patients must have a serum creatinine ≤1.5 x IULN within 7 days prior to randomization.
  • Prior malignancy is allowed providing it does not require concurrent therapy. Exception: Active hormonal therapy is allowed.
  • Patients must not be pregnant or nursing due to the teratogenic potential of the drugs used on this study.
  • Patients known to be HIV+ are eligible provided they meet all other eligibility criteria and have undetectable HIV viral loads.
  • Specimens (peripheral blood) must be collected and submitted to a CLIA-approved laboratory as outlined in Section 15.1, within 21 days prior to randomization. BCR-ABL transcripts must be measured using RT-PCR and results must be reported using the International Scale. The RT-PCR assay must have the sensitivity to detect a 4.5 log reduction in BCR-ABL transcripts from baseline (at least 0.0032% IS).
  • Patients must be offered participation in submission of specimens for central BCR-ABL quantification. This submission is highly encouraged as an important protocol endpoint. With patient’s consent, specimens must be collected and submitted as outlined in Section 15.2, within 21 days prior to randomization.
  • Patients must be offered participation in specimen banking for future research. With patient’s consent, specimens must be submitted as outlined in Section 15.3.





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